Finalist: The Wall Street Journal, by The Wall Street Journal

For "Deadly Medicine," a stellar reporting project that documented the significant cancer risk to women of a common surgery and prompted a change in the prescribed medical treatment.

Nominated Work

November 22, 2014

Medical device sidelined too late to save some

By Jennifer Levitz and Jon Kamp

Linda Interlichia arrived alone at her family’s Cape Cod vacation home a half-mile from the beach last fall. Her routine there had been unchanged for years: She opened the doors to let the breeze flow in from the marsh and sat on the deck in the afternoon, sipping a glass of Chardonnay.

The second night, ease gave way to dread. Heavy pelvic bleeding left her faint, and the next morning, she drove herself to the emergency room.

It was, she confided to her husband, Frank, among the most frightening episodes in her life. The hemorrhaging under control, she returned home to Rochester, N.Y., and saw her doctor the same week.

To Mrs. Interlichia’s relief, her gynecologist, Wendy Dwyer, linked the bleeding to benign uterine growths, she said, and offered an enticing solution, a brochure extolling a robot-assisted hysterectomy through tiny incisions.

“She slapped it on the table between us as we sat in her office like she was giving me a Christmas present,” Mrs. Interlichia said.

“She said I’d be up and running — she knew I liked to jog — in three weeks with minimal scarring and pain,” she said.

“I left thinking I didn’t have a care in the world.”

But her problem wasn’t benign. It was an aggressive cancer, leiomyosarcoma, identified only after her surgery.

And Dr. Dwyer had used a laparoscopic power morcellator, a tool inserted through an incision to cut up and remove the uterus.

A morcellator can leave behind bits of malignant tissue that seed multiple new tumors, scientists say. No one told Mrs. Interlichia her October 2013 surgery would use a morcellator, she said. Eight weeks later, another doctor found a softball-size mass and other tumors in her pelvis that he said weren’t there before her hysterectomy.

“It is terrible,” Dr. Dwyer said this month, her voice catching with emotion. “It’s never what I wanted for her.” Little was known about the cancer in the past, she said, and it was good it was now being looked at. She declined to comment further for this story.

Dozens of cases have come to light this year of women whose cancers rapidly worsened after morcellation. The U.S. Food and Drug Administration warned in April that the tools can worsen cancer. The top U.S. morcellator maker, Johnson & Johnson, halted sales in April, and many hospitals have curtailed their use.

While the newfound scrutiny of the morcellator may save lives, women like Mrs. Interlichia and their families are still paying a grim price for decisions they and their doctors made not long before the alarms rang.

“Looking back now,” Mrs. Interlichia said this June, “I wish I had asked more questions.”

When Mrs. Interlichia, a Rochester copy editor, came to Dr. Dwyer in 2013, most gynecologists still rarely told patients that a morcellator might spread cancer. The risk was considered too small.

Dr. Dwyer didn’t suggest options other than robotic surgery, Mrs. Interlichia said, and “I figured she would tell me what was best.”

She went in for surgery Oct. 21, 2013, expecting a quick recovery. Her husband found her chatting with the nurse in good spirits in the recovery room. “The patient tolerated the procedure well,” Dr. Dwyer wrote in postoperative notes that day.

The shock came 10 days later. As the Interlichias sat in Dr. Dwyer’s office, they said, the gynecologist seemed near tears as she told them what she had thought was a fibroid, a common benign growth, was actually leiomyosarcoma.

“I felt bad for her,” said Mrs. Interlichia. “She was devastated it happened.” Soon after, she dropped off a gift — holiday-themed socks — for Dr. Dwyer.

The couple still hadn’t heard the word “morcellator.”

That came eight weeks later. In late December, she visited Dr. Christopher Awtrey, gynecologic oncology director at Boston’s Beth Israel Deaconess Medical Center, for exploratory surgery to see if her cancer had spread.

Leiomyosarcoma experts like Dr. Awtrey say there is far greater probability of recovery if surgeons remove the uterus intact. Once spread, the malignancy usually isn’t curable, cancer experts say.

Mrs. Interlichia lay in her hospital bed, gripping her husband’s hand as she listened to Dr. Awtrey explain the morcellator and describe her tumors. Fragments left behind had embedded in her abdomen and grown wildly, he concluded.

“That tumor, once morcellated, appeared to be like a small fire with gasoline on it,” he told the Journal.

Mrs. Interlichia told him she wished she had sought a second opinion. “He said I could have gotten a second, third, fourth and fifth opinion, and they would all say the same thing. This has been gynecologists’ common practice,” she said. Dr. Awtrey corroborated the conversation.

More women are choosing robotic hysterectomies, which offer quicker recovery and less scarring than open surgery and are easier for some doctors than manual laparoscopic surgery.

In early January, she became aware of surging publicity around the morcellator’s risk.

Dr. Amy Reed, a Boston anesthesiologist, had gone public in December with her story: After a hysterectomy for fibroids, she learned a hidden cancer had been morcellated.

Mrs. Interlichia started following news on the issue closely as she began chemotherapy. She lost her long hair, which she had dyed blond. Photos after that point show her with short gray hair.

In April, as she was trying a second type of chemotherapy — the first failed to stop tumor growth — she was shocked to read a Wall Street Journal page-one article showing there had been years of scattered but accumulating evidence of the morcellator’s risk.

Days later, the FDA issued its advisory. That was some comfort, but Mrs. Interlichia was troubled to read of a divide in gynecology: Some doctors were still using the device, insisting the FDA had overreached.

“I think this is mostly public relations and not science,” one doctor told the Journal in a May 21 article Mrs. Interlichia read. Incensed, she would later write to the FDA: “As I lay in my hospital bed after

a second surgery to address the damage done by my hysterectomy ... I was anything but fodder for a public relations scheme.”

That month, in one of her first public outings after losing her hair, she saw her youngest daughter, Grace, graduate from college. Her other daughter, Katie, was in graduate school in Boston.

Mrs. Interlichia insisted that her illness not throw her two daughters’ lives off track. “Look, if you think you’re going to come back to Rochester and stare at us and cry, that is not what we want,” she told them. The daughters were heartbroken about their mother’s diagnosis, her husband said.

As summer approached, Mrs. Interlichia began frequenting websites for women and families who had morcellation experiences, learning of other women like her in Rochester.

One was Brenda Leuzzi. In 2012, doctors at a University of Rochester Medical Center hospital diagnosed her with bleeding from fibroids. The Zumba instructor had a hysterectomy with morcellation in September 2012, records provided by her lawyer show.

She screamed when she got the call with a postsurgery diagnosis: leiomyosarcoma.

She and her husband, Rochester firefighter George Leuzzi, in May filed suit against J&J’s Ethicon unit, the morcellator’s maker, in New York federal court, alleging it sold an unsafe product and failed to adequately warn of dangers.

An Ethicon spokesman said it “acted appropriately and responsibly in the development, testing, marketing, and voluntary withdrawal of our devices.”

When Mrs. Interlichia connected online with Mrs. Leuzzi’s family, Mrs. Leuzzi was already in the late stages of cancer. Mrs. Leuzzi’s uncle, Gene Manley, who planned to testify at FDA hearings on the device, asked Mrs. Interlichia if he could mention her name. She agreed, also writing her letter to the FDA.

“There is no justification in the world for a doctor making my condition worse when it was absolutely avoidable,” she wrote. “I had hopes, dreams, plans and a life I loved. In short, I am a human being, not a data point.”

The Interlichias watched the July FDA hearing on a laptop while she was receiving chemotherapy. One panel member, Craig Shriver, a surgical oncologist at Walter Reed National Military Medical Center, said: “There is at present no safe way to offer laparoscopic power morcellation as part of any minimally invasive surgery.”

But some who testified defended morcellators, Mr. Interlichia said, and “we stopped watching because it was too upsetting to hear such vigorous defense of the process that put her in that infusion chair.”

At the hearing, Mrs. Leuzzi’s uncle found another Rochester-area cancer victim’s husband, Jim Leary, a police officer from Greece, N.Y. Mr. Leary told of how his wife, a church-preschool teacher, had died.

Barb Leary, a mother of two, had come in with bleeding to her gynecologist in 2009. The doctor diagnosed fibroids, and she had morcellation at Rochester General Hospital, according to records provided by her family.

Days later, the pathology report revealed Mrs. Leary had leiomyosarcoma. “It was like getting hit with a baseball bat upside the head,” Mr. Leary said.

Barb Leary died of the cancer in September 2013 at age 52.

The gynecologist who performed her surgery was Dr. Dwyer. A month after Mrs. Leary’s death, Dr. Dwyer, who is affiliated with Rochester General, would morcellate Mrs. Interlichia.

Mrs. Interlichia knew of Mrs. Leary through an online community. “When I learned she had done this before, unfortunately to Barbara, I was stunned,” Mrs. Interlichia said of Dr. Dwyer after a Journal reporter told her of the connection. “It’s a depth of anger and shock that’s hard to quantify or express.”

Dr. Eugene Toy, Rochester General’s chief of obstetrics and gynecology, declined to discuss patients. Rochester General, where Mrs. Interlichia and Mrs. Leary had their surgeries, suspended power morcellation after the FDA advisory, and he said the new policy showed the hospital was doing all it could to reduce risks.

Mrs. Interlichia wrote Mr. Leary an email suggesting they meet, but she became too ill. Her MRI showed two tumors were growing and several new ones had appeared.

Instead, in August, her husband met Mr. Leary at a Rochester Italian restaurant. Mr. Interlichia had a beer. Mr. Leary nursed a Jack Daniel’s. Each ordered another.

“For the first time, I was able to really talk to someone who understands what I went through with Barb,” Mr. Leary said. He shared the little things he had done as she weakened, like how he learned the smell of coffee made her feel nauseated and stopped making it around her.

“We drank a bit and talked about our sad, common bond,” Mr. Interlichia, who oversees fundraising at the University of Rochester Medical Center, said a few days afterward. “We certainly share anger.”

Soon their group included Mr. Leuzzi, who knew of Mrs. Interlichia’s case from support websites. “There’s a unique bond between the three of us,” Mr. Leuzzi said. “I can’t describe how terrible this ordeal has been,” he said. “There’s only a few people out there who understand that.”

Late this summer, Mr. Leuzzi was busy caring for his wife, who was often doubled over in pain.

Her cancer was “unexpected and tragic,” said Dr. Marit Sheffield, who evaluated Mrs. Leuzzi before surgery. Her surgeon, Uma Penmetsa, said of Mrs. Leuzzi that “she is helping physicians to rethink if, when, and how to use power morcellation, which until recently, has been standard practice.”

The two doctors declined to say whether they told Mrs. Leuzzi about the morcellator and its risks. University of Rochester said its hospitals stopped using power morcellators in May.

Dr. Joseph Skitzki, a sarcoma specialist at Roswell Park Cancer Institute in Buffalo, N.Y., evaluated Mrs. Leuzzi this year and said he believes morcellation worsened her cancer.

In an interview this summer, Mrs. Leuzzi said she was heartbroken she wouldn’t see her 3-year-old daughter, Peyton, grow up. She blamed morcellation for robbing her of a fair fight against her cancer.

With another procedure, Mrs. Leuzzi said, “I would have had more time.”

Mrs. Interlichia, too, had other minimally invasive options that would have given her a fighting chance, Dr. Awtrey said. Preoperative tests, he believed, showed she could have had a vaginal hysterectomy.

“My most fervent wish,” Mrs. Interlichia said this summer, “is to make sure this never happens to anyone else.”

By September, Mrs. Leuzzi was too weak to talk. Mrs. Interlichia had tried three types of chemotherapy, but her tumors kept growing. Midmonth, she traveled with her husband to their Cape Cod house but could only manage walks to the end of the street.

By October, Mrs. Leuzzi was bedridden. Mrs. Interlichia, who needed help standing up, eventually stopped treatment. “I am not afraid,” she told her husband.

Brenda Leuzzi died Oct. 24, 2014, at age 44.

Linda Interlichia died one week later, on Halloween. She was 55.

December 16, 2014

Devices get quick approval, little follow-up from FDA

By Jon Kamp and Thomas M. Burton

The Food and Drug Administration’s warning last month was unusual: Doctors shouldn’t use a common surgical tool on most women because it can spread hidden uterine cancer.

A year earlier, the FDA had no official concerns about laparoscopic power morcellators, which it began approving in 1991.

The November warning came after multiple cases emerged this year of women whose cancers worsened after surgery with the devices used to cut and remove tissue in procedures such as hysterectomies.

The FDA over two decades cleared at least 10 such morcellators from various companies through a streamlined process that lets a device maker seek approval by showing a product is similar to an already-approved device.

Congress created that expedited process in 1976. The FDA used it to review 99% of about 3,000 new medical-device applications it cleared in the 2013 fiscal year. In contrast, the FDA has recently approved roughly 30 new drugs each year, after stringent reviews that usually require controlled clinical trials that can take years.

The agency didn’t start studying how morcellators might harm women until December 2013, after The Wall Street Journal highlighted the tools’ hazards.

The FDA system clears thousands of devices that doctors use to help maintain the health of millions of Americans.

There is no evidence the FDA’s oversight of morcellators departed from its standard procedure, and no one suggests that the FDA approved faulty morcellators or that the tools failed to work as designed.

Instead, the device’s tragic effects on some women illustrate one shortcoming of America’s medical-device regulation system, say some researchers who have studied it.

“There are too many approved moderate and high-risk devices that get on the market lacking high-quality evidence that they are safe and effective,” says Rita Redberg, a University of California, San Francisco, cardiologist who studies device regulation.

In 2011, a panel at the influential Institute of Medicine, which reviewed the system at the FDA’s request, called for scrapping the approval process, concluding its main test — whether a device is “substantially equivalent” to a prior product — fails to prove devices are safe or effective.

It found “substantial weakness” in the FDA post-approval safety monitoring.

Dr. William Maisel, the FDA medical-device center’s chief scientist, says that the approval process is a good way to “balance innovation and safety” and that the agency is strengthening its surveillance of devices on the market.

Still, he says, “it’s a legitimate question to ask” whether early clues “should have raised a caution about fibroids,” benign growths that sometimes turn out to be uterine cancer a morcellator can spread.

He says only an extremely large clinical study could have turned up early evidence of the morcellator’s risks and that the FDA didn’t act because “the agency and the clinical community didn’t have an appreciation of the risks of cutting presumably benign fibroids.”

The Journal reviewed regulatory documents and other records showing how the tools made it to market. The tale begins with a provision named 510(k). Part of the 1976 law that systematically regulated medical devices, it was meant to “grandfather in” certain pre-1976 devices and to simplify approval for tools that were substantially similar to them.

The 510(k) review was to be an exception and its purpose wasn’t to stress safety, says former FDA Commissioner David Kessler, but “the exception became the rule.”

It was a 510(k) review the FDA used in 1991 to first approve a laparoscopic power morcellator, a device that played into a movement toward “minimally invasive” surgery, in which doctors operate through tiny incisions.

The applicant, Cook Urological Inc., in its documentation cited as precedents four devices, including manual morcellators called “tissue punches” and a motorized tool for clearing matter in joint surgery.

Cook documents viewed by the Journal didn’t list any clinical trials. In most cases, 510(k) reviews don’t require the kind of controlled human tests that most drugs go through. Device makers typically perform so-called bench tests — such as stressing components to measure durability — and may test on animals.

“With a mechanical instrument, the idea was that you can predict the effects on health with some certainty,” says Bradley Merrill Thompson, a medical-device lawyer in Washington, “whereas a drug permeates your body and is harder to predict.”

By 1991, it was well known that cutting cancer in the body could spread it. Doctors typically cut out tumors intact, often in surgical bags to avoid contamination.

Cook Inc., of which Cook Urological is a unit, says its morcellators were designed for use with protective bags. April Lavender, Cook’s senior vice president of regulatory affairs, says the FDA didn’t ask questions about cancer-spreading risk during the review.

One FDA reviewer did express concern the Cook morcellator might constitute a riskier device. Its design and intended use, the reviewer wrote, “led me to believe that it could be used for liposuction” which FDA rules regarded as high-risk.

The FDA often gives more-stringent reviews to high-risk devices — a tiny portion of reviews — that can include clinical trials. Cook added an anti-liposuction warning, and the FDA approved its morcellator.

The FDA declined to comment on discussions during the review. Cook says it discontinued the morcellator in 2001 due to competition.

Cook’s device would beget a chain of other morcellator approvals through 2011, with each new application citing prior models.

In December 1994, Karl Storz Endoscopy-America Inc. asked the FDA to clear its new morcellator, citing the Cook tool as one precedent. In a January 1995 phone call, FDA medical officer Daniel Schultz expressed concern to Storz that the tool could spread dangerous cells, application documents show.

The same day, he wrote in a summary for the record that the device “must be used with an appropriate tissue extraction bag for malignant and other tissues which are potentially harmful if disseminated within a body cavity.”

The FDA approved Storz’s morcellator for general surgery in early 1995. Later that year, it cleared it as the first power morcellator approved for gynecology. Karl Storz GmbH didn’t respond to inquiries. Dr. Schultz doesn’t dispute the documentation.

The Storz tool’s instructions called for bags where doctors suspected tissue was cancerous. But gynecologists often can’t detect a cancer called uterine sarcoma with certainty until after surgery.

Most gynecologists didn’t end up using bags with morcellators, they say, in part because they considered them clumsy and unreliable. And they broadly considered uterine sarcoma rare — as low as one in 10,000. Some early studies suggested otherwise. A 1990 study found that in 1,429 surgeries for presumed uterine fibroids at a Los Angeles hospital, about one in 200 women had hid den sarcoma. A 1994 study of 1,332 patients found a one-in-444 ratio. The FDA cited the studies in an advisory this April.

“In retrospect,” Dr. Schultz says, “the labeling maybe should have been, ‘Do not use if there is any question of malignancy.’”

He later became director of the FDA’s medical-device center, leaving in 2009.

Any individual report might not have been enough to raise alarms, and it took years for scientific evidence to accumulate.

Companies and the FDA aren’t required, under the 510(k) system, to scour scientific literature for studies on a tool’s potential risks, says Mr. Thompson, the device lawyer.

The FDA’s Dr. Maisel says it didn’t act because “the agency and the clinical community didn’t have an appreciation of the risks of cutting presumably benign fibroids.”

The Storz morcellator joined the precedent chain. In 1996, California-based FemRx Inc. cited it in an application that included draft instructions copied almost verbatim from the Storz language on bags and cancerous tissue.

FemRx application documents viewed by the Journal don’t otherwise mention cancer-spreading risk.

The FDA approved the device in 1997. It declines to comment on the discussions during the review.

A spokesman for Johnson & Johnson, which bought FemRx in 1998 and eventually became America’s biggest morcellator seller, says “we appropriately engaged with the FDA as part of the regulatory approval process” and that the 510(k) process “has worked well for three decades and has evolved when appropriate to better serve patients.”

Morcellators gained traction, helping gynecologists offer women faster recoveries and fewer complications than open surgery. The 1995 Storz approval covered gynecology and fibroids. Doctors are allowed to use tools “off label,” and some began using morcellators for hysterectomies as well.

The FDA cleared a J&J device in 2000 for hysterectomies — a precedent cited by some others.

Some new reports found relatively high hidden-sarcoma rates, including studies in 1999 and 2008 suggesting rates from one in 462 women to one in 253 — studies the FDA cited this year.

The FDA had tools to monitor the morcellator’s impact. One tool failed: Maude, a database to which the FDA requires hospitals and device makers to report cases linking devices to deaths and serious injuries. The database didn’t receive any reports of cancers that morcellation might have worsened until December 2013, the FDA says.

Another tool was the FDA’s power to order a company to probe the safety record of a device that got 510(k) clearance and that presented a potential health risk. The FDA says it has never ordered such a probe on morcellators.

An FDA spokeswoman says: “The magnitude of the risk of spreading unsuspected uterine cancer via morcellation was not recognized until the issue gained prominence in December 2013.”

A 2008 morcellator application explicitly mentioned cancer risks. Gyrus ACMI Inc. asked the FDA to approve a model that cuts with energy rather than the spinning tubular blade most use, listing a J&J model as one precedent.

Gyrus documents show researchers assessed “the risks associated with ‘seeding’ of cancerous or pre-cancerous cells” while cutting beef parts stuffed in a Yorkshire pig.

Regulatory documents show one tester, gynecologist Thomas Lyons, reported that the device “presented a lower risk in comparison to competitor products” because it destroys cells and “does not cast tissue.”

Dr. Lyons confirms those remarks but says he doesn’t believe morcellation affects the trajectory of uterine cancer.

Olympus Corp., which bought Gyrus in 2008, declines to comment on the application. The FDA didn’t respond to inquiries about the device.

The FDA approved the device and, through 2011, cleared morcellators from at least three other companies: Nouvag AG, LiNA Medical ApS and Trokamed GmbH. Nouvag declines to comment. LiNA and Trokamed didn’t respond to inquiries.

That year, South Korean researchers raised alarms by reporting that a 56-patient review showed cutting up uterine tumors, rather than removing them intact, was more likely to spread cancer.

In 2012, the FDA said it planned to mine insurance and hospital databases for device problems. It declines to say whether it has done so for morcellators.

Two 2012 studies showed one-in-223 and one-in-546 hidden-sarcoma rates after surgery for benign diagnoses.

This year, the FDA cited those two studies, the Korean report and other literature as part of the probe it began in December 2013. The agency in April estimated one in 350 women undergoing surgery for fibroids are found to have uterine sarcoma.

J&J halted morcellator sales in April. Other morcellator companies haven’t announced plans to suspend sales.

Like morcellators, some other devices have won FDA approval after which dangers emerged. Many doctors have used so-called vena cava filters to stop blood clots. The FDA, which first allowed the current generation of the devices in the 1980s, issued a safety alert in 2010 about adverse events including movement of fractured pieces to the heart.

“Clearly the performance of the products was not sufficient,” the FDA’s Dr. Maisel says, adding that the agency is requiring a detailed study of inferior vena cava filters.

Along with beginning to mine databases, the FDA is working toward placing identifying numbers on devices. It says the surveillance improvements will help it better collect data and may be able to identify safety issues such as the morcellator’s faster.

Dr. David Challoner, who headed the IOM panel calling for regulatory overhaul, credits the FDA for working on these repairs.

“Industry’s interest with all of these devices is to get through the process and get on the market as soon as possible,” he says. The public’s interest “is to get the unexpected, faulty device out of the market as soon as possible.”

Jennifer Levitz contributed to this article.

April 12, 2014

Doctors discounted early hints of popular procedure’s risks

By Jennifer Levitz and Jon Kamp

The women’s health-care community got a shock to the system in December, when leading U.S. hospitals abruptly began acknowledging that a commonly used surgical tool risked killing some women.

The tool, used since the 1990s in many hysterectomies, can stir up aggressive cancers, they said. Brigham and Women’s Hospital, Temple University Hospital and others quickly altered their procedures for the tool’s use. The Food and Drug Administration has begun a probe of its risks.

Yet there were hints of the tool’s potentially fatal flaw going back to its early years. Doctors use the device, called a power morcellator, through tiny incisions to cut into, or “morcellate,” the uterus and remove it. The procedure is popular because it allows speedier recovery than open surgery and is easier to perform than many alternatives.

Doctors who trained others on some early morcellators, including one named “Diva,” noticed in the late 1990s that they sometimes left behind tissue fragments. Data as early as 2003 suggested that, if those bits were malignant, they could seed rapid cancer growth. Although some morcellator makers have long recommended containing risky tissue in a surgical bag — standard practice in many specialties gynecologists rarely used bags, considering the risk too low and their use too cumbersome.

“I don’t think there is an acceptable safe morcellator” without systems to contain tissue, said Bobbie Gostout, Mayo Clinic’s chairwoman of obstetrics and gynecology, at a 2011 conference where a study highlighted the device’s cancer-spreading risk. That risk, she said, “seems just out of bounds.”

Many doctors still support morcellator use and believe the procedure can be done safely.

But new safety worries have prompted many to re-evaluate how they use the tools. The issue went mainstream in December after Brigham said that, by using a morcellator in an October hysterectomy, it may have inadvertently worsened the cancer of Amy Reed, a 41-year-old anesthesiologist at Beth Israel Deaconess Medical Center. Beth Israel, like Brigham, is at Harvard Medical School teaching hospital in

Boston.

Brigham, which later confirmed publicly that its procedure worsened Dr. Reed’s cancer, says it hadn’t known she had the malignancy, didn’t use a surgical bag and didn’t warn her of the cancer-spreading risk. She and her husband, a Brigham surgeon, have since lobbied regulators, lawmakers, companies and medical societies for a morcellator moratorium.

Now a growing number of specialists say doctors and device makers, while playing up the morcellator’s benefits, overlooked its risks. And the U.S. medical system, they say, systematically failed to disclose those risks to women.

Gynecologists “were using their best professional judgment to offer something they saw as beneficial,” says David Boruta, a Massachusetts General Hospital oncological gynecologist, “and unfortunately didn’t think about that risk as much as they should have.” Doctors commonly warn patients of far-slimmer risks, he says, such as of contracting HIV through transfusions.

Until Dr. Reed’s tragedy, even leading hospitals like Brigham, Temple and Massachusetts General continued to allow morcellator use without requiring surgical bags or disclosure of cancer-spreading concerns. The risk, says Robert Barbieri, Brigham’s obstetrics and gynecology chairman, was considered too small. Massachusetts General says it wasn’t aware until December of the complication and hadn’t ever had such a case.

That small risk has been too real for women like Nancy Lincoln Davies. Ms. Davies, a 59-year-old glider instructor, thought she had a benign growth called a fibroid when her surgeon from the Dartmouth-Hitchcock health system in New Hampshire performed a hysterectomy in September 2012. Her doctor used a morcellator, a device that typically employs rotating cylindrical blades at the tip of a shaft through which the uterus is then extracted.

Only afterward did doctors discover she was among the estimated 0.2% whose presumed fibroids prove to be uterine sarcoma after surgery. The cancer is stealthy: Doctors generally can’t diagnose it until it is removed.

Ms. Davies died last summer after her cancer spread. Her husband, Glenn Davies, says her doctor told the couple that morcellation probably worsened the cancer and said a bag wasn’t used.

Dartmouth-Hitchcock declines to comment on Ms. Davies’s case. It says her cancer type, “when morcellated, has a higher chance of recurrence than if not morcellated,” that it discloses the risk “case-by-case” and that bag use is “at the discretion of the surgeon.” Mr. Davies says doctors didn’t reveal that risk. “If they had told her, she definitely would not have wanted it.”

Since December, such cases have helped drive a rush to analyze the tool’s risk and rethink procedures.

Uterine sarcoma can still be fatal if left alone or removed in an intact uterus through other surgeries. But “morcellation appears to worsen prognosis” by disseminating cancer cells, concluded a recent analysis overseen by doctors at Cleveland Clinic and other leading hospitals who examined literature on morcellation through March 2014, including data back to 2003 that suggest the cancer risk.

In an unpublished December paper responding to Dr. Reeds’s case, Harvard Medical School and Boston University doctors estimated uterine morcellation “results in hundreds of avoidable deaths each year.”

Temple University Hospital in February limited morcellation to a narrow range of cases and only with a bag. Enrique Hernandez, the head gynecologist who set Temple’s new policy, says his hospital uses a morcellator that cuts with electricity rather than a blade, which he says has less potential to spread tissue. The device’s maker, Olympus Corp., says it encourages customers to follow standards set by national medical societies.

Brigham and Massachusetts General this year mandated bags. “We believe that use of a containment

system will minimize the potential risk,” says Brigham’s Dr. Barbieri.

Hospitals including Cleveland Clinic, Temple, Brigham, Massachusetts General and Beth Israel say they now mandate disclosing the risk. Insufficient disclosure “is one of the most essential issues in this,” says Christopher Awtrey, Beth Israel’s gynecologic oncology director.

A spokeswoman for Mayo says it continues to do morcellations using “case-by-case judgment,” declining to elaborate on its procedural policies. Mayo “is committed to the safety of its patients and is participating in a multi-institution review of practice and outcomes related to morcellation,” she says.

The morcellator’s proponents say it is an important option. It “has brought huge benefits,” says Franklin Loffer, medical director for AAGL, formerly the American Association of Gynecologic Laparoscopists. Dr. Loffer retired as a gynecologic surgeon in 2009.

“While all pelvic surgeries carry risk,” says a spokesman for Johnson & Johnson’s Ethicon division, which bought the Diva’s maker in 1998 and is now the largest U.S. morcellator maker, “morcellation is considered to be a safe and effective treatment option for many patients when compared to alternative procedures.”

He says J&J models have always included cautions about the potential spread of harmful tissue, including “uterine sarcomas which are extremely rare, occurring in only a fraction of a percent of patients.”

Today, 55,000 to 75,000 U.S. hysterectomies a year involve morcellators, estimate gynecological groups and research hospitals. Doctors also use them in myomectomies, the removal of fibroids alone. Other makers of morcellators using powered blades include companies such as Karl Storz GmbH and Richard Wolf GmbH. Storz and Wolf didn’t respond to inquiries.

Morcellators were a welcome innovation for many.

Roughly a half-million U.S. women have hysterectomies each year, 40% for fibroids, by some estimates. Doctors most commonly remove the uterus intact through incisions sometimes 7 inches long in open surgery that is more prone to complications like bleeding and infection than less-invasive options. It can require several days in the hospital and up to six weeks’ recovery.

One less-invasive approach is to remove the uterus intact through the vagina. Many specialists consider it the preferred method, but performing it can be more difficult than some other methods.

Another that has gained popularity in many disciplines is “laparoscopic” surgery, in which the surgeon makes small incisions to insert a camera and surgical instruments and operate without opening the body. Complications include possible urinary-tract injuries and longer operating times.

But a hysterectomy patient can sometimes go home the same day, for two to four weeks’ recovery.

Early on, few doctors did laparoscopic hysterectomies, partly because morcellating manually was difficult. The breakthrough came in the 1990s, when the FDA began clearing power morcellators through a streamlined process it applies to many devices.

Gynecologists say a big shift happened in 1997, when the FDA cleared the Diva. Its California maker, FemRx, touted it as safe and better for patients.

Morcellation caught on among gynecologists, who found it simpler than other approaches. It also played into a popular theory that the cervix was important for sexual function and should be left intact — a so-called supracervical hysterectomy.

“Industry really pushed that supracervical deal,” says William Saye, a retired gynecologist who helped develop laparoscopic surgery and prefers vaginal hysterectomies.

The American Congress of Obstetricians and Gynecologists has refuted the cervix theory.

Lori Jennings, a former FemRx executive who worked at J&J, says sales weren’t driven by device makers as much as by “far more pull” from doctors and women who “demanded that procedure like you wouldn’t believe.”

Doctors soon saw morcellators could leave tissue. David Olive noticed that, when he worked with FemRx to train doctors on the Diva, some fragments were so hard to find that “eventually, people started leaving little bits.” Dr. Olive, president in 2001 of the AAGL gynecologist group and now a Wisconsin fertility specialist, says the morcellator’s benefits outweigh its risks.

Training on the Diva’s descendants took off after J&J bought FemRx, say doctors who attended training at sites in Florida and Texas. “They would fly you up there and put you in a hotel to work with these morcellators,” says Cranston Cederlind, a Kansas gynecologist who later helped demonstrate them in a broadcast.

Dr. Cederlind and others say safety training focused on factors such as avoiding nearby organs. They recall emphasis on removing bits of tissue. Dr. Cederlind says the morcellator’s risks are low and the training was appropriate.

“We offer training to surgeons on the safe and effective use of our products,” the J&J spokesman says.

Bodies can absorb fragments, but benign pieces can attach to organs and grow. A 1998 paper described a morcellation leaving a “lost” mass lodged near the liver, prompting major surgery. “It was a chunk of uterus and just in a bad place,” says the author, Francis Hutchins Jr., a retired gynecologist known as the “Fibroid King.” He says the morcellator was an important advance that benefited patients but “is not an absolute necessity.”

The potentially fatal risk comes when lost tissue is malignant.

Uterine sarcoma affects fewer than 1 in 10,000 women, but about 1 in 500 with presumed fibroids prove after surgery to have malignancies, according to some studies. Surgeons in specialties like urology typically enclose an organ in a bag before cutting it by hand. J&J and Storz in instructions advise doctors to use bags if worried about harmful tissue.

Dr. Olive and others contacted by the Journal who gave morcellator training don’t recall bags being used in training. Bag use doesn’t appear in several training videos reviewed by the Journal.

Steven McCarus, a Florida gynecologist who trained doctors on J&J morcellators and appears in a Storz-backed video, says bags weren’t in training because they were difficult to maneuver over enlarged uteruses and because there hasn’t been a bag that is up to the job. “The solution,” he says, is to “be careful and remove all tissue.”

Dr. Loffer, AAGL’s medical director, says because so few women had problems, “morcellating within a bag did not achieve widespread prominence within our field.”

In 2011, South Korean researchers caused a stir at a Florida conference by reporting that a 56-patient review showed morcellating tumors, rather than removing them intact, was more likely to spread cancer. Among women whose tumors were removed intact, 19% died within 63 months; 44% with morcellated tumors died within 39 months. Boston and German researchers later produced similar data.

“I think it’s a misstep for us as a profession to have accepted morcellation” without some containment, said

Mayo’s Dr. Gostout at the conference. The Mayo spokeswoman declines to say what impact those remarks had on Mayo’s procedures. She says Dr. Gostout stands by the remarks. Ms. Davies didn’t know of the risk when she began having unbearable pelvic pain. Her doctor diagnosed a fibroid, recommending a procedure involving morcellation. “There was no warning that ‘hey, if this is more than a fibroid, here

is what can happen,’” her husband says.

The couple learned at a postsurgery appointment that her “fibroid” was cancer. “We looked it up afterward, sitting at the kitchen table,” Mr. Davies says. “We had no clue” of the risk. Ms. Davies’s abdomen filled with tumors and she died last July.

Hospitals say mandating bags should allow safer morcellations. Using them “will provide our patients with the safest and highest quality care,” says Brigham’s Dr. Barbieri, “while preserving the advantages of laparoscopic surgery.”

Gynecology groups expect to issue new guidance soon. The ACOG group recently said power morcellators aren’t needed for minimally invasive options, such as removing the uterus vaginally or through medium-size incisions.

April 18, 2014

FDA warns on popular medical procedure

By Jennifer Levitz and Jon Kamp

Federal regulators advised doctors Thursday to stop using a surgical device used in tens of thousands of hysterectomies each year, citing its potential to spread cancer.

The move by the Food and Drug Administration could change the way many women are treated for common but often painful growths in the uterus known as symptomatic fibroids, which spur about 40% of the roughly half-million hysterectomies performed annually in the U.S., by some estimates.

The agency’s safety alert follows a series of articles in The Wall Street Journal that reported on the risk of using the device and a campaign started earlier by two Bostonarea physicians to halt the procedures.

The instrument, known as a power morcellator, typically uses a tube-shaped blade to slice up and remove fibroids or the entire uterus, avoiding the long surgical scars associated with traditional, open surgery. But it can also spread an often undetectable cancer known as a uterine sarcoma, according to the FDA.

In a rare safety alert for medical devices — addressed to doctors, medical associations, hospitals, women, device manufacturers and advocacy groups — the FDA cited estimates that this cancer affects one in 350 women undergoing such procedures and that power morcellation can significantly worsen the odds of long-term survival.

“For this reason, and because there is no reliable method for predicting whether a woman with fibroids may have a uterine sarcoma, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids,” the agency said in a communication posted on its website Thursday. Myomectomy is the removal of just fibroids.

“In general, the procedure should not be performed,” Dr. William Maisel, deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health, said at a media briefing.

If doctors do perform such procedures, the FDA said, they should advise patients of the cancer-spreading risk.

The concern is that using a powered device to slice undetected, cancerous tissue within the abdomen -- and without any protective measures -- raises the risk of malignant cancer cells embedding in other tissue and elevating the cancer to a more dangerous stage, studies have shown.

Because uterine sarcomas can’t be reliably detected before they are removed, they can be mistaken for fibroids. The cancer is typically discovered only after the mass has been removed and tissue sent to a pathologist.

This was the situation that ensnared Amy Reed, a 41-year-old mother of six and anesthesiologist at Boston’s Beth Israel Deaconess Medical Center, who developed advanced uterine cancer shortly after a routine hysterectomy in October. The hospital where she was treated, Boston’s Brigham and Women’s Hospital, acknowledged that use of morcellation worsened her cancer.

The FDA began its review in December, “when some high-profile cases covered in the media came to our attention,” Dr. Maisel said. The agency also noted there are many alternatives, including minimally invasive surgery without morcellators, vaginal hysterectomies and open surgery. There are also nonsurgical options including drug therapy and ultrasound treatment.

The agency’s alert prompted some to act immediately Thursday. Dr. Isaac Schiff, chief of the Department of Obstetrics & Gynecology at Massachusetts General Hospital, said, “I have asked our doctors to stop the procedure immediately until we have more information.”

Robert Barbieri, obstetrics and gynecology chairman at Brigham and Women’s Hospital, told surgeons Thursday that “we are immediately suspending use of this device in all cases until further notice,” according to an emailed statement. Both hospitals had previously put tight restrictions on morcellators in response to cancer concerns.

Morcellators, introduced in the 1990s, have helped gynecologists

perform about 50,000 fibroid-removal procedures

each year through tiny holes, the FDA estimated,

rather than longer incisions that can lead to bigger scars

and a longer recovery.

The FDA doesn’t directly regulate how doctors practice medicine, but advising against a procedure can significantly change practice by raising the risk of lawsuits for doctors who go against that advice, legal experts said.

“The fact that the FDA released this warning makes it more likely that a doctor who went against it will be held to have practiced in a way below the standard of care,” said I. Glenn Cohen, a Harvard Law School professor who specializes in health-law policy and bioethics. “Second, this increases the chance that a patient may succeed in suing for a failure to get informed consent.”

With the issue gathering steam since December, gynecological societies had already been doing their own reviews of power morcellation. Commenting on the FDA move, the American College of Obstetricians and Gynecologists said its own review is ongoing. “We greatly appreciate the urgency behind the issue,” the group said.

Some gynecologist have argued there are several ways to perform minimally invasive procedures without using morcellators, including cutting tissue manually inside protective bags. Gynecologists have said they seldom used these bags during hysterectomies and fibroid procedures previously.

A number of top hospitals have recently told their doctors only to morcellate inside bags. The FDA instructed morcellator manufacturers “to review their current product labeling for accurate risk information for patients and providers.”

A spokesman for Johnson & Johnson’s Ethicon subsidiary, the largest maker of power morcellators, said the company will review its product labeling as the FDA requested and supports plans for an advisory committee meeting. He noted that J&J’s uterine morcellator instructions have always recommended doctors use protective bags when using the device on malignant or suspicious tissue.

“This is an important announcement by the FDA, and we support any measures that enhance patient safety, which is always our first priority,” the spokesman said.

Diana Zuckerman, president of the nonprofit National Research Center for Women & Families, and an advocate for stiffer medical-device regulations, said the FDA’s statement should have a major impact. “What surgeon is going to take the chance of using this device if the FDA has made such a strong warning?” she said. The FDA’s action “is going to save a lot of lives.”

April 30, 2014

Cancer risk halts sale of surgical tool

By Jon Kamp

Johnson & Johnson, the largest maker of devices used in a popular uterine surgery, said Tuesday it has suspended sales of the tools amid concerns about their potential to spread a rare but deadly cancer.

The health-care giant said it was halting world-wide sales, distribution and promotion of the tools called power morcellators but not permanently pulling them from the market.

The action follows a Food and Drug Administration advisory on April 17 discouraging doctors from using the devices to remove fibroids — common but often painful uterine growths — because of a risk of worsening an often-hidden cancer.

The FDA has said it plans an advisory committee meeting this summer to examine the tools’ use. J&J wrote in a letter to customers that it is waiting for the FDA and the medical community to further clarify the role of morcellation in fibroid treatment.

J&J, which began selling the devices in 1998 through its Ethicon division, said the instructions have always cautioned doctors about the potential spread of malignant or suspicious tissue. But the company acknowledged it is difficult to diagnose some cancer ahead of surgery.

“We believe that suspending the commercialization of these products until their role is better understood and redefined by the medical community is the appropriate course of action at this time,” J&J told customers.

Morcellators typically use long, tube-shaped blades to cut and remove tissue through tiny incisions, helping patients avoid open abdominal surgery associated with longer scars and recovery. The FDA has estimated morcellators are used about 50,000 times yearly to perform fibroid-removal procedures. Overall, fibroids account for about 40% of the roughly 500,000 hysterectomies performed annually in the

U.S., by some estimates.

Fibroids are most often benign. But the FDA cited a 1 in 350 risk that women undergoing surgery to remove these growths have an undetected cancer known as a uterine sarcoma.

The risk of spreading this cancer with morcellators — highlighted in a series of Wall Street Journal articles — erupted into a gynecological debate late last year after a Boston-area couple began raising an alarm.

Amy Reed, a 41-year-old mother of six and anesthesiologist at Boston’s Beth Israel Deaconess Medical Center, developed advanced uterine cancer shortly after a hysterectomy in October. The hospital that performed the procedure, nearby Brigham and Women’s Hospital, acknowledged that use of morcellation worsened her cancer.

The sales halt doesn’t prevent doctors from using devices already in inventory, and J&J hasn’t recalled those devices. But several hospitals, including Cleveland Clinic and Brigham and Women’s, have suspended morcellator procedures.

Other smaller morcellator manufacturers include Karl Storz GmbH, Olympus Corp. and Richard Wolf GmbH. Storz and Wolf didn’t respond to a request for comment. An Olympus spokesman declined to comment.

May 22, 2014

Deciding against morcellation may have saved her life, patient believes

By Jennifer Levitz

Colorado chemist and college instructor Debra Grymkoski believes her awareness of the potential risks of power morcellation may have saved her life.

Ms. Grymkoski, 53 years old, was diagnosed earlier this year with fibroids, common and benign uterine growths that can cause pressure and bleeding. She scheduled a minimally invasive hysterectomy, in which her doctor would remove her uterus through a small incision.

But before her planned surgery in late March at St. Mary- Corwin Hospital in Pueblo, Colo., she read a Wall Street Journal article highlighting a debate about power morcellators, bladed devices used to slice up fibroids or the uterus so tissue can be taken out in small pieces. The U.S. Food and Drug Administration hadn’t yet issued an April 17 advisory against the tool. But there was growing concern among some doctors that the instruments could spread and worsen cancer in cases where presumed fibroids turn out to be sarcomas, a type of cancer that can’t be diagnosed with certainty before surgery.

She voiced her worries to her doctor, who agreed to not use the device despite believing the risks were negligible.

“I think my initial reaction was, ‘Oh, this is rare,’” said her doctor, Stephen Wassinger. “But I tucked it away in the back of my head. If a patient doesn’t want something, that’s their right.”

He removed her uterus vaginally, without a power morcellator.

Her pathology report came back: She had a type of uterine sarcoma called an endometrial stromal sarcoma.

A scan this month showed no signs of cancer in Ms. Grymkoski, and she is hopeful about her future. “I feel lucky,” she said.

“I walked away from that almost dumbfounded,” said Dr. Wassinger. “Using a morcellator would have saved me 30 minutes of surgery, but it would have ultimately been much worse for her prognosis.”

Dr. Wassinger said his close call and the FDA advisory has altered his approach. He isn’t using a power morcellator, and if he resumes, it will be on patients with detailed informed consent. “I don’t think a lot of people would accept that risk, and that’s OK,” he said.

Ms. Grymkoski agreed to share her experience so she can empower other women. “If it’s going to save someone else or have someone else make the right decision, then I think it’s worth it,” she said.

May 22, 2014

FDA advisory vexes doctors

Cancer Concern Over Uterine Procedure Prompts Split in Medical Community

By Jennifer Levitz and Jon Kamp

An advisory from the Food and Drug Administration that strongly cautioned doctors against performing a common surgical procedure on women is upending the landscape of gynecological care across the U.S.

The FDA surprised gynecologists last month when it issued an advisory against using a device called a laparoscopic power morcellator, saying it can spread a dangerous hidden cancer. The bladed tool is used in minimally invasive surgeries to slice up and remove uterine growths called fibroids, sometimes as part of a hysterectomy.

No figures are available on how many doctors have chosen to heed the nonbinding warning, which the agency plans to revisit at a hearing this summer. But dozens of interviews show the advisory has divided hospitals and gynecologists, many of whom are still using the device, and left women puzzling over their options. The tool was being used in an estimated 50,000 U.S. uterine surgeries each year.

The FDA said women undergoing surgery for what look like benign fibroids actually have a 1 in 350 risk of hosting an undetected cancer called a uterine sarcoma. Morcellating these tumors can spread cancerous tissue internally and significantly worsen the odds of long-term survival, the agency said.

Johnson & Johnson, the largest morcellator maker, suspended global sales soon afterward, though it said it continued to stand by the product’s safety and effectiveness.

The company said the device’s instructions have always cautioned doctors about the potential spread of malignant or suspicious tissue. But it acknowledged it is difficult to diagnose some cancer ahead of surgery.

A number of doctors believe the FDA overreached, and think the cancer risk is so small that gynecologists can go an entire career without seeing a case. Others call the advisory a necessary precaution.

Hospitals and private practices are taking an array of approaches. The University of Pittsburgh Medical Center system, which has more than 50 obstetrics and gynecology practices, opted to continue using the device.

The medical system changed its informed-consent forms to include wording on cancer risk and told doctors to discuss the risk with patients. But Allen Hogge, chairman of obstetrics, gynecology and reproductive sciences there, questioned the data behind the FDA’s estimate. The FDA began looking at the issue after media reports late last year about a prominent Boston doctor who discovered she had sarcoma after morcellation.

“I think this is mostly public relations and not science,” Dr. Hogge said. In response, the FDA said it conducted a rigorous analysis of published literature.

Duke University Health System also continues to use the power morcellator after gaining a patient’s informed consent.

But HCA Holdings Inc., a major for-profit health-care company with hospitals and surgery centers in 20 states, recommended its affiliated doctors follow the FDA’s guidance, a spokesman said.

In upstate New York, Unity Health System, which has hospitals and practices around Rochester, declared a moratorium on power morcellators six weeks ago but said it plans to revisit the issue next month.

Other doctors say their move away from the device may be permanent. “I probably will not ever use it again,” said Plano, Texas, gynecologist Keith Reisler, who said the rare exception might be an obese patient who could have a higher risk from a large incision. “The recent numbers [on cancer risk] made me uncomfortable because the question is: What are we going to find out next?”

The advisory roiled Florida Hospital, an Orlando-area system that is home to one of the primary J&J training centers for the tool. “There [were] very strong emotions on all sides of the fence and a lot of people quite frankly upset with the FDA’s warning,” said Chief Medical Officer Neil Finkler, a gynecologic oncologist. Dr. Finkler said he treated two patients who died from sarcomas after morcellations performed by other doctors, and agrees with the FDA’s guidance. The Florida

Hospital system chose to suspend the practice.

The conflicting views are confounding some women who wonder if they should opt for another choice such as open abdominal surgery, which has a longer recovery time and carries its own risks, or vaginal procedures, which are considered to be the best option but one that not all gynecologists know how to perform.

After three years of painful fibroids, Terri Keeler, a 44-year-old school aide and spinning instructor in Wexford, Pa., was heading for a laparoscopic hysterectomy using morcellation. But she paused this month to balance the FDA’s advisory against comments from her University of Pittsburgh doctor, who she said told her that a hidden sarcoma was very rare.

Suketu Mansuria, Ms. Keeler’s doctor and the assistant director of gynecologic minimally invasive surgery at the medical center, acknowledged the conversation, one he’s had with several patients. “I say that in my opinion, one in 350 is an overestimation,” he said. He said the choice is always up to the patient.

The clashing opinions have “totally confused things,” Ms. Keeler said. “I’m questioning what I’m going to do.”

Medical societies, including the influential American College of Obstetricians and Gynecologists, recently further complicated the debate. ACOG issued a statement on May 9 defending morcellation for many patients. The group acknowledged the cancer-spreading risk, which it said should be disclosed, but said the procedure spares women more invasive surgery.

ACOG’s view carries weight with doctors, hospitals, health insurers and malpractice liability insurers. Doctors Co., the largest doctor-owned malpractice insurer, plans to note both the FDA advisory and the ACOG response in the next issue of a publication it sends to 75,000 physicians, said David Troxel, the insurer’s medical director.

“I don’t want to pre-empt the national medical specialty society when they get on this right away,” Dr. Troxel said. His Napa, Calif.-based company hasn’t advised doctors on whether to use morcellators, but will advise them to discuss the risks, benefits and alternatives with patients, Dr. Troxel said.

Another liability insurer, ProAssurance Corp. of Birmingham, Ala., said it has received many questions on morcellation from hospitals and doctors. The insurer doesn’t give clinical advice but also is stressing the need for informedconsent discussions with patients, a spokesman said, including making sure patients are aware of the FDA advisory.

February 20, 2014

Video: Hospital restricts procedure that may lead to cancer

April 30, 2014

Cancer risk raises doubts over FDA oversight of medical tools

By Jon Kamp

A U.S. Food and Drug Administration database that catalogs medical-device problems holds thousands of entries on a tool called a laparoscopic power morcellator, used since the 1990s.

But before December, none of those reports linked the tool to a potentially deadly risk: worsening a rare and oftenhidden uterine cancer. Instead, older entries documented malfunctions and occasional injuries to patients.

Medical literature had highlighted the risk since the tool’s debut. But the FDA didn’t begin to closely examine the danger until late last year, when a Boston doctor took her case public in The Wall Street Journal.

As the FDA prepares to hold hearings this week on the power morcellator’s future, critics say the case demonstrates weaknesses in the surveillance system. An agency panel will hear testimony Thursday and Friday.

Morcellators slice up common and generally benign uterine growths called fibroids so they can be removed through small incisions in minimally invasive procedures. In April, the FDA discouraged these procedures, estimating one in 350 patients could have a concealed cancer that the devices may spread.

Through medical records and doctor interviews, the Journal has identified at least two dozen cases before December where morcellators likely worsened cancer. Medical journal articles have also identified cases.

“Why is it that even when we know numerous women have already had this happen to them, it’s not in the database?”asked Diana Zuckerman, president of the National Center for Health Research, a nonprofit that advocates for product safety.

The FDA approves nearly all devices through a process that typically allows products deemed substantially similar to something already marketed to be sold without clinical-trial data. The FDA has said it is unlikely a more intense review would have highlighted the morcellator’s cancer risk sooner.

The FDA in recent years developed a blueprint for significant surveillance improvements. But for now, its principal tool remains a system that gathers reports on problems in a database called Maude, which can be mined to find or analyze these problems, said Rita Redberg, a cardiologist at the University of California, San Francisco Medical Center who is critical of FDA surveillance efforts.

The agency requires hospitals and device makers to chronicle cases linking devices to deaths and serious injuries. Doctors don’t have to report issues, although they are encouraged to.

The FDA said it long knew morcellators could spread uterine cancer, but the fresh attention prompted new analysis that found a higher-than-realized cancer risk. The agency said it didn’t know why it didn’t receive reports of cancer worsened by morcellators before December but noted doctors would have to connect advanced cancer cases to an earlier procedure.

At times, connections were made but not reported. Boston’s Brigham and Women’s Hospital confirmed two instances where morcellation worsened cancer, including the case that sparked public debate last year. While the hospital regularly files device reports, risk managers there didn’t think this was a reportable issue, a spokeswoman said.

“The devastating outcome was the result of the undetected cancer, not device malfunction or failure,” she said.

Regulatory experts said the hospital should have reported the cases. But they also said lax enforcement gives little incentive to call out mishaps.

The FDA said it found that encouraging more and better reports from hospitals and doctors, rather than levying sanctions, is the best use of limited resources.

The lack of earlier morcellator alarms worries Jim Leary, a Greece, N.Y., police officer whose wife, Barbara, died in September. She was diagnosed with uterine cancer in 2009 after a doctor at Rochester General Hospital used a morcellator to remove what looked like a benign fibroid, according to the patient’s records.

A month after she died at age 52, the same doctor performed a similar procedure on another woman who is now battling advanced cancer, according to the patient’s records. The hospital and doctor have declined to discuss these cases.

More than 20 reports linking morcellation and cancer have filtered into Maude since December. Some came from patients, others from doctors, and several came from Johnson & Johnson, the largest maker of the device. They were triggered by lawsuits and news stories, a J&J spokesman said. J&J halted global morcellator sales after the FDA’s April advisory, though it has defended the devices’ safety.

July 11, 2014

Doctor with industry tie leaves FDA safety panel

By Jennifer Levitz

SILVER SPRING, Md. — A member of a panel advising the government on the safety of a medical device that can spread cancer in women stepped down after the U.S. Food and Drug Administration reviewed consulting fees he accepted from a device manufacturer, the agency said Thursday.

San Francisco gynecologist Andrew Brill removed himself from the 16-member panel before two days of hearings on the device were set to begin Thursday, an FDA spokeswoman said. A spokesman for Dr. Brill referred questions to the FDA.

In 2013, he received nearly $100,000 in consulting fees from Johnson & Johnson subsidiary Ethicon, according to J&J’s website. Ethicon is by far the largest manufacturer of a tool known as a laparoscopic power morcellator. The advisory panel is expected to recommend to the FDA whether regulations governing morcellators, used in an estimated 50,000 hysterectomies a year, should be altered.

“The FDA has a rigorous conflict of interest process in place designed to ensure the integrity of our meetings. During the course of the agency’s review and in consultation with Dr. Andrew Brill, it was determined that the financial information he disclosed was just above the threshold established for panel members to participate in one of our meetings,” an FDA spokeswoman said.

The Wall Street Journal first asked the FDA and Dr. Brill about the consulting fees on Tuesday after comparing publicly released names of the members of the panel with a list of paid consultants on J&J’s website and other public documents.

The agency declined to speak until Thursday morning. J&J, which appears to be the only morcellator manufacturer that releases names of its paid consultants, said Dr. Brill has done professional education consulting in the firm’s women’s health and energy businesses and that he is a recognized leader in the field.

The FDA assembles its own advisory panels and requires members to report any financial interests members might have in the subject matter. The agency declined to release disclosure statements submitted by morcellator panel members, citing privacy laws. In evaluating potential conflicts, the test is whether “the need for the individual’s services outweighs the potential for a conflict of interest created

by the financial interest involved,” FDA policy says.

The agency says that it would generally automatically disqualify applicants whose potentially conflicted financial interests — or those of immediate family members — top $50,000 from participating in a meeting.

At least two other gynecologists on the panel have had financial ties to manufacturers, according to J&J’s website and other public documents.

Michael P. Diamond, a Georgia gynecologist and acting chairman of the FDA panel meeting on morcellators, was previously a consultant for Ethicon and received a grant from the company, he said Thursday in response to a question from the Journal. He declined to say the amount he received, which wasn’t available on the J&J website.

Keith Isaacson, a Boston-area gynecologist, received nearly $12,000 in consulting fees from Ethicon in 2013. according to the J&J website. His work for the firm has been as a “professional-education consultant,” a J&J spokesman said. A spokeswoman for Dr. Isaacson said he wouldn’t comment until after the hearing ends Friday.

Both doctors remain on the panel. The FDA declined to comment on the doctors, saying it doesn’t discuss sitting members’ disclosures.

Morcellators are used to cut up common uterine growths called fibroids, often in a hysterectomy, so they can be removed from the body via small incisions. But the devices can sometimes spread a rare cancer that masquerades as benign fibroids.

The risk had been known for years but was believed to be extremely small. In April, the FDA said the risk was higher than previously thought and discouraged doctors from using morcellators while it considered a more permanent position on the tools.

The hearing Thursday drew patients, relatives, doctors and industry representatives.

“Because morcellation upstaged her cancer, Elizabeth never had a chance,” Joanne Jacobson told the her sister, who died from cancer in January 2013 following a morcellation procedure, according to her medical records.

JoAnn Trainer urged a ban on cutting tissue inside the body while speaking on behalf of her daughter Amy Reed, a Boston physician whose post-morcellation cancer case triggered alarm that led to this week’s meeting. Dr. Reed plans to speak Friday.

The head of the influential American College of Obstetricians and Gynecologists said taking away morcellators will drive more women to elect open abdominal surgery, which carries its own risks, such as infection.

J&J halted all sales shortly after the FDA advisory. Piet Hinoul, vice president of medical affairs at Ethicon and a gynecologist, said the company stands by this decision until there is consensus about how to mitigate the risk.

Jon Kamp contributed to this article.

July 23, 2014

New cancer risk seen from medical tool

Morcellators, Used in Uterine Procedures, May Spread More Types of Malignancy, Study Finds; Report Backs FDA’s Concern

By Jennifer Levitz

A surgical device commonly used in hysterectomies has the potential to spread more types of cancer in a woman’s body than previously thought, new research released Tuesday shows.

The report in the Journal of the American Medical Association also reinforces an earlier government assessment that use of the device, a laparoscopic power morcellator, is risky.

In April, the Food and Drug Administration advised doctors to stop using morcellators for removing fibroids in the uterus. The agency concluded the device could spread previously undetected cancerous tissue inside the body, significantly worsening the patient’s odds of survival.

The new study by Columbia University doctors found that 1 in 368 women undergoing hysterectomies have a hidden uterine cancer that is at risk of being spread by a morcellator. Significantly, the research examined the records of a much larger group of women than the FDA did in its main analysis.

Many gynecologists disputed the FDA data and its assessment of the device’s danger. The agency held a two-day hearing on the issue earlier this month and is expected to decide this year whether to restrict or even ban use of morcellators.

Doctors not involved in the new study said its findings make clear that the device puts a segment of women at risk.

“This just confirms it,” said David Mutch, chief of gynecologic oncology at Washington University School of Medicine and Barnes-Jewish Hospital in St. Louis.

Morcellators deploy spinning blades to slice uterine fibroids or the uterus itself into fragments that can be removed through tiny laparoscopic incisions. Johnson & Johnson, the largest maker of the tool, suspended sales after the FDA’s warning.

Using a database of insurance information, the authors of the new study, which was funded by the National Cancer Institute, identified more than 36,000 women treated with the device at 500 U.S. hospitals over seven years. The research found a level of hidden-cancer risk similar to the FDA report.

Beyond that, the researchers found the procedure presents the risk of spreading other types of cancer beyond the uterine sarcomas that had been the focus of concern. The study included all cases of women who were found to have uterine cancer after they underwent morcellation, including endometrial cancer, which is far more common.

The study didn’t say whether their cancer was worsened by the procedure. “Certainly that is the next step, to answer those questions,” said Jason D. Wright, the lead author of the report and director of gynecologic oncology at the Columbia University College of Physicians and Surgeons.

Sarcomas can masquerade as benign fibroids. Doctors can test before surgery for endometrial cancer, which begins in the lining of the uterus. But endometrial cancer isn’t always detectable, Dr. Wright said. “I think this provides important information showing that there is certainly a risk of cancer, not only sarcomas, but endometrial cancer at the time of morcellation,” he said.

Moreover, other types of gynecologic cancer and precancerous tissue were found to have been missed before surgery and morcellated, Dr. Wright said.

The authors said patients should be counseled about the risks of undetected cancerous and precancerous conditions before undergoing the procedure.

Estimates dating to the 1990s suggested that the odds of an undetected uterine cancer were rare — as low as 1 in 10,000 cases. But a few studies back then found the risk as high as about 1 in 500 cases. A recent meta-analysis by the FDA put the risk even higher, at 1 in 352, but that estimate was criticized by many specialists as relying on thin data and not rigorous enough to warrant a crackdown on the device.

Proponents of the surgical tool argue that its benefits — helping doctors perform a less-invasive operation — make it too important to ban. Some gynecologists contend that without morcellators, more women will undergo traditional abdominal hysterectomies, which often result in bigger scars, longer recoveries and more complications.

Opponents call the risk too high for an elective procedure, and note there are alternatives. To that point, the study found that morcellation was performed in only about 16% of the more than 230,000 minimally invasive hysterectomies it looked at.

Dr. Wright said the authors of the JAMA report conducted the study because of publicity about the device, led by The Wall Street Journal, which first reported on the issue in December.

Some families hope the new research will spur sharper restrictions on the device. “I just think it’s got to get stopped,” said Glenn Davies, of Salem, N.H. In 2012, a doctor diagnosed his wife, 59-year-old Nancy Lincoln Davies, with a fibroid and used a morcellator during a hysterectomy, her records show. Her mass was actually cancer, and she died 10 months later.

August 19, 2014

Personal Journal: Answers for women with fibroids

By Angela Chen

After a popular method of removing uterine fibroids has come under intense scrutiny, many women are wondering what other options they have.

Laparoscopic power morcellation is a minimally invasive surgery that breaks up the benign growths, usually found in the uterine wall, and removes them in pieces, sometimes as part of a hysterectomy. The Food and Drug Administration advised against the procedure in April, saying it can spread a dangerous cancer hiding undetected in the growths. The FDA’s warning was nonbinding and the agency, which may weigh in on the matter further, hasn’t issued a final recommendation.

Meanwhile, Johnson & Johnson, the largest manufacturer of power morcellators, the tool used in the procedure, voluntarily withdrew its device from the market.

Still, the picture isn’t clear-cut. The influential American College of Obstetricians and Gynecologists says it still considers the procedure appropriate for some patients, in part because it spares some women more invasive surgery.

As the medical debate continues, here are some answers to questions women might have right now:

Q: I’ve been diagnosed with fibroids. What risk is there it’s cancer?

A: Overall, uterine sarcoma, the type of cancer under scrutiny in these cases, is rare in the U.S., with an estimated three to seven cases annually per 100,000 women. But the incidence appears to be much higher in women with fibroids who undergo either a hysterectomy (uterus removal) or myomectomy (fibroid removal without disturbing the uterus).

The FDA estimated in April there is a 1 in 350 chance that a woman getting surgery for fibroids might actually have undiagnosed uterine sarcoma. Morcellating these tumors can spread cancerous tissue internally, the agency said. A new study, published in the Journal of the American Medical Association in July, found the risk of undetected cancer was 1 in 368. The study looked at data from 36,000 women who had chosen a power-morcellation procedure for hysterectomy, says Jason Wright, director of gynecologic oncology at Columbia University College of Physicians and Surgeons, and lead researcher for the study. “Our findings are similar to, and back up, what the FDA reported,” he says.

Q: What factors make me more likely to have cancer?

A: The older you are, the more likely you are to have potentially undetected cancer, says Dr. Wright. Based on data from his study, a woman between the ages of 50 and 54 has 20 times as great a risk as someone who is under 40, he says.

Dr. Wright also found that African-American women having power morcellation were less likely to have undetected cancer than other ethnic groups. This may be because African-American women are more prone to benign fibroids, so statistically a smaller percentage of them are likely to harbor undetected cancer, he says.

Q: Given the risks, what are the advantages of power morcellation?

A: Power morcellation may still be the best option for some women, says Hal Lawrence, chief executive of the American College of Obstetricians and Gynecologists. All medical procedures carry risk, he says, and rather than discounting power morcellation completely, patients should consult with their doctor about the specific situation. For example, the risk of undetected cancer in women in their 30s is extremely low, so power morcellation may still be a viable option, he says.

Power morcellation also has advantages over laparotomy, a common alternative, Dr. Lawrence says. A laparotomy, in which the uterus or fibroids are removed through a large incision in the abdomen, has a relatively long recovery time -- four to six weeks, compared with about two to four weeks for a laparoscopic hysterectomy that may include power morcellation. It is also more painful and has a higher risk of infection due to the large incision. Risks from a laparotomy, such as recovery time, are heightened for overweight or obese women.

“Often, obese patients will have existing medical problems like hypertension and diabetes, which can

further complicate recovery from an abdominal hysterectomy,” says John Schorge, chief of gynecology at Massachusetts General Hospital. “The minimally invasive approach, compared with open [abdominal] hysterectomy, has huge advantages for the obese population.”

Q: Are there additional options?

A: There are other surgical options, and deciding between them can depend on various factors, including the size of the uterus and fibroids. As with all major surgery, patients should consider getting a second opinion.

A laparotomy has the most risks due to the large incision and long recovery time. Deciding between a hysterectomy and a myomectomy often depends on the fertility plans of the patient, Dr. Lawrence says. A mini-laparotomy involves removal of the uterus or fibroids through incisions that are smaller than for a laparotomy, but larger than the ones used in power morcellation.

For women also getting a hysterectomy, many doctors consider the best option to be vaginal hysterectomy -- in which the uterus is removed through the vagina. It avoids abdominal incisions and is associated with the fewest complications, Dr. Lawrence says. But not all gynecologists routinely do vaginal surgeries, and they may steer patients to other options for anatomical reasons, such as an enlarged uterus.

There are also nonsurgical options, including medications, ultrasound and uterine artery embolization, a procedure that cuts off the blood supply to the fibroids. All are intended to help shrink the size of the fibroids, says Dr. Lawrence.

Q: Is there a safer way to perform power morcellation?

A: Some doctors perform power morcellation inside a bag, which is removed after the procedure and is meant to prevent potentially cancerous fibroids from being left in the body. It is a “cleaner” alternative and can potentially solve the morcellation problem, says Dr. Schorge, but many gynecologists haven’t been trained to use the bags and so the procedure isn’t common.

If the morcellating tool hits the bag, it can tear the bag, causing it to malfunction, says Dr. Lawrence. The bag also limits how well the surgeon can see. He notes that bags designed specifically for power morcellation are being developed.

Q: I had a power morcellation in the past. Might I have undiagnosed cancer now?

A: This is extremely unlikely, Dr. Schorge says. Any cancer is usually detected immediately, as soon as the morcellated pieces are tested after the procedure.

September 21, 2014

Video: The Short Answer: Uterine fibroid procedure risks spreading cancer

September 22, 2014

Gynecologists resist FDA over popular surgical tool

By Jennifer Levitz and Jon Kamp

Doctors nationwide are still using a gynecological tool months after the U.S. Food and Drug Administration warned that it can spread undetected cancer, demonstrating the limits of the regulator’s reach into clinical practice.

Since the FDA warning in April, Johnson & Johnson pulled the device called a laparoscopic power morcellator from the market; many hospitals, such as Boston’s Brigham and Women’s Hospital and Philadelphia’s Temple University Hospital, put moratoriums on the tool; and some regional insurers stopped covering its use.

Still, some gynecologists continue to employ morcellators to remove common benign uterine growths known as fibroids, often in minimally invasive hysterectomies. The tool slices tissue into fragments so it can be removed through small incisions, but the procedure can leave bits of tissue behind that can continue to grow and spread, whether benign or unexpectedly malignant.

These doctors say they believe the risks of unknown cancer have been overblown and the government shouldn’t interfere with patient treatment.

“It is none of their business,” said Jeffrey Thurston, 58, a Dallas gynecologist who has practiced for three decades and said he performs 80% of his hysterectomies with a morcellator.

He points to patients such as 51-year-old Valerie McKenzie, who had fibroids and underwent the procedure this month. Ms. McKenzie, of Las Cruces, N.M., said she rebounded quickly.

She had been leaning toward a vaginal hysterectomy — another minimally invasive option endorsed by the main gynecological society as the safest choice — but said she chose to have laparoscopic surgery after Dr. Thurston explained the benefits.

Dr. Thurston asks patients undergoing power morcellation to sign an informed-consent document that describes the cancer-spreading risk and puts the risk of an undetected sarcoma at between 1 in 300 and 1 in 1,000.

But “we tell them verbally that we don’t think those numbers are correct,” he said. He also tells patients there is no good data to show morcellation worsens sarcoma.

The FDA regulates pharmaceuticals and medical devices but doesn’t oversee the practice of medicine, where doctors have wide latitude. In April the agency estimated that 1 in 350 women undergoing surgery for fibroids have an undetected dangerous cancer that the tool can spread — far higher than the risk was generally believed to be — and discouraged its use. The move sharply divided the field while prodding many gynecologists to stop using the tool. Some are exploring other minimally invasive options.

Among them was Robert Graebe, the chairman and program director of the Department of Obstetrics and Gynecology at Monmouth Medical Center in New Jersey. At first he thought the FDA had overreached but now agrees. He thinks morcellators should be shelved until proven safe. “What you do about it is: You stop,” he said. “People want to fight back, but it’s not putting patients’ safety first.”

But the FDA didn’t ban the morcellator and is considering its options after a July hearing.

Smaller manufacturers have filled the void left by J&J, which said it was uncertain whether the device’s benefits outweighed its risks. The company noted that uterine can cers called sarcomas can masquerade as fibroids and can’t be reliably detected before surgery. One smaller manufacturer, Richard Wolf GmbH, cited a gynecology association’s defense of morcellation and said treatment options are up to doctors.

Wolf said it has been following the debate closely.

The number of gynecologists still employing morcellators is difficult to estimate. The American College of Obstetricians and Gynecologists, the field’s main medical society, isn’t tracking it. But interviews with many doctors show that a segment of the field has dug in to defend its use, with more informed consent and some adaptations.

Their decision reflects their skepticism that the FDA acted too quickly and spooked women who could benefit from a surgery that the FDA estimated in April was being performed at least 50,000 times a year.

Laparoscopic surgery offers quicker recovery times and less bleeding and risk of infection than open surgery, although there are minimally invasive surgeries that don’t require power morcellation. Some hospitals that have suspended morcellator use are doing more vaginal hysterectomies as well as “mini-laparotomies,” in the incisions are smaller than in open surgery. These techniques may also involve cutting, but surgeons say it can be done manually and more easily in bags.

Atlanta gynecologist Michael Randell now shows patients a morcellator and videos before surgery. He sometimes also uses the tool inside a surgical bag, a controversial solution that some believe could prevent stray bits of tissue. He said careful patient selection can lessen the risks, and he warns patients that certain cancers can’t be detected definitively before surgery. He also tells them he has never

seen a case.

“I always caution and say, ‘It doesn’t mean you’re not going to be the one,’” to have undiagnosed cancer, Dr. Randell said.

Gynecologists are now broadly disclosing morcellator risks to their patients, something they acknowledge was seldom done before. But the experience and opinions of individual doctors can color how they relay this information.

Thomas Lyons, a minimally invasive pioneer in Georgia, has encountered uterine cancer called leiomyosarcoma in his practice but continues to use the device in some cases. Dr. Lyons said he has had five patients with this cancer that revealed itself after he performed morcellation, either with a power tool or knife to remove growths. He said he didn’t see any spread of malignancy in routine follow-up visits and doesn’t believe evidence shows morcellation affects the trajectory of the cancer.

The FDA has defended its analysis. But pushback has come from high levels in gynecology.

The American College of Obstetricians and Gynecologists argues that with more stringent patient selection, the device remains an important tool.

AAGL, a medical association formerly known as the American Association of Gynecologic Laparoscopists, recently suggested that the range for one particularly dangerous form of sarcoma was anywhere from roughly the FDA’s number to 1 in 7,400. The upper end came from an analysis led by Elizabeth Pritts, a Wisconsin gynecologist. One of her co-authors is husband David Olive, a gynecologist who was an early industry trainer. They are seeking to publish the analysis and continue using morcellators.

The FDA has acknowledged the evidence that morcellation spreads hidden cancer is limited. But the agency says there is consistency across small studies showing a worsened prognosis when hidden cancers are cut up inside the body.

The FDA’s analysis was no surprise to some doctors who had long harbored concerns. “I see these patients — it’s terrible,” said Mark Wakabayashi, co-director of the Gynecological Cancers Program at City of Hope hospital near Los Angeles. “That makes no sense to think that when you cut through these cancers that you don’t do harm. That’s actually kind of scary.”

November 22, 2014

The rise of surgical robots spurred morcellator use

By Jennifer Levitz and Jon Kamp

After Linda Interlichia, Barb Leary and Brenda Leuzzi were diagnosed with fibroids, they underwent robot-assisted hysterectomies.

That’s a common approach: Last year, 191,000 U.S. hysterectomies were robot-assisted, according to data from Intuitive Surgical Inc., maker of the da Vinci, the only robot approved for gynecology.

Robotic surgery, like manual “laparoscopy,” operates through small incisions, offering quicker recoveries and fewer complications than open surgery. The transition to the robot is good because most such hysterectomies would be open surgeries otherwise, said Dr. Thomas Payne of AAGL, formerly American Association of Gynecologic Laparoscopists.

But as hundreds of thousands of U.S. women chose robotic hysterectomies for benign diagnoses, some doctors opted to use a technology the Food and Drug Administration in April warned can worsen cancer: the power morcellator.

With more robots, “you have a bigger bucket of people getting morcellation, and that is why we are seeing more unwanted side effects, including disseminated cancers,” said Dr. Jason Wright, Columbia University Medical Center’s division chief of gynecologic oncology.

Gynecologist Joseph Castelli of Pueblo, Colo., said he rarely did manual laparoscopic hysterectomies. “With robotics, I could do things that I couldn’t do laparoscopically,” he said. “Some of it to me was just so difficult, I didn’t feel comfortable.” He seldom used morcellators before, but did in about 10% of his robotic procedures.

He stopped after the FDA’s April warning that morcellators can spread cancers.

The robot’s rise — the FDA cleared it for hysterectomies in 2005 — contributed to growing morcellator sales until safety concerns became widespread in late 2013, said senior analyst Manya Aggarwal at research firm Decision Resources LLC.

Morcellators, which remove the uterus through incisions, don’t attach to robots. And most robotic hysterectomies use other uterus-removing methods, such as through the vagina. Estimates put morcellation at under 10% of robotic hysterectomies for benign diagnoses and roughly 20% of non-robotic laparoscopic hysterectomies until morcellator use fell off.

“Given the benefits minimally invasive surgery offers, women should discuss this option — without morcellation — with their surgeons to determine the procedure that is best for them individually,” said Intuitive’s chief medical officer, Myriam Curet.

The American College of Obstetricians and Gynecologists says using robots for routine hysterectomies doesn’t improve outcomes over other minimally invasive options and calls vaginal hysterectomies the best option.

November 24, 2014

Cancer-risk debate didn’t halt surgeries

By Jennifer Levitz

BOSTON — Doctors at a prominent Boston hospital continued to use a surgical tool during hysterectomies for two years after compiling data in 2011 that questioned the safety of the device and discussing its risks, said hospital officials and doctors.

Brigham and Women’s Hospital curtailed use of the device, the laparoscopic power morcellator in December 2013, acknowledging it had spread a dangerous cancer in two of its patients, one in 2012 and the other in 2013. In March, the Harvard University-affiliated hospital became one of the first to stop using the tool.

The hospital’s debate illustrates the difficulty of pinpointing surgical risks and balancing them against the benefits of medical technology. The Food and Drug Administration is considering that balance as it prepares to make a decision about the morcellator’s future soon.

The device is used to cut up and remove tissue during minimally invasive procedures to treat fibroids, which are common benign growths. The growths, however, are sometimes a cancer that can’t reliably be detected before surgery. Morcellation can send pieces of malignant tissue into other parts of the abdomen, significantly reducing a woman’s chance of long-term survival, the FDA said.

A woman undergoing a hysterectomy for fibroids has a 1 in 350 chance that the growths are uterine sarcoma, the FDA estimated in April. The risk previously was believed to have been far lower. The agency began studying the issue after one of the two Brigham patients, 41-year-old Amy Reed, went public with her case late last year. She had a hysterectomy with morcellation in October 2013 and later learned she had cancer.

Brigham said the data compiled by its doctors, which found a 1 in 546 risk of sarcoma, was too limited in 2011 to support a shift in hospital practice. Moreover, none of the procedures examined that had spread cancer had been done at Brigham, so the hospital said it couldn’t be sure they were performed according to its standards.

“The widely held belief in the field at the time, which we shared, was that based on all available data, the benefits of morcellation outweighed the risks for the majority of patients thought to have fibroids,” the hospital said in a statement. “We now believe that we had an under-appreciation of the risk.”

Rick Kaitz, a Boston lawyer whose wife, Erica, was the other Brigham patient whose cancer inadvertently was morcellated, believes the hospital should have changed its approach earlier. “This is not a complicated topic: If there is any chance of an unknown malignancy, you just don’t morcellate it,” he said.

Ms. Kaitz had an undetected cancer that worsened after a hysterectomy with morcellation at Brigham in 2012. She died in December 2013 at age 52.

The hospital called Ms. Kaitz’s case “devastating,” but said her 2012 cancer diagnosis didn’t prompt an immediate change in hospital practice because her age and symptoms led the facility to conclude she was a victim of what was then believed to be an extremely rare outcome.

Brigham’s research took root in late 2009, said pathologist Michael Seidman, who was the lead author of the study. He said a Brigham surgeon operating on a woman after she had undergone fibroid surgery with power morcellation was surprised to see multiple raised bumps in her abdominal cavity.

Unsure what they were, he asked pathologists to investigate, Dr. Seidman said. The pathologists determined they were pieces of the same tumor that was morcellated. It wasn’t cancer, but a type of mass that doctors fear may become so.

The researchers found 1,091 incidents of Brigham patients in which morcellation was used to remove presumed fibroids between 2005 and 2010. They found women had a 1 in 546 chance of having sarcoma, similar to what the FDA later found.

Upon follow-up, neither of the two in-house sarcoma cases had spread. The authors also looked at referral cases of seven patients whose power morcellation had been done at outside hospitals, and found four with sarcomas that had spread.

The group presented the preliminary unpublished results in April 2011 at a formal weekly meeting at which Brigham gynecologists discuss cases or new research.

Robert Barbieri, Brigham’s chairman of obstetrics and gynecology, recalled that one of the authors, Dr. Michael Muto, a gynecologist oncologist, suggested the risk was significant enough to warrant considering a change in practice.

But minimally-invasive gynecologic surgeons, Dr. Barbieri said, worried that would lead to more women undergoing open surgery, which brings its own set of risks, including more bleeding, as well as larger scars and longer recovery time.

Both Drs. Seidman and Muto, who commented through a spokeswoman, recalled that the conversation turned to whether gynecologists should alter what they were telling patients about power morcellation.

At the time, the potential risk wasn’t included in the hospital’s informed-consent process. Both doctors indicated the consensus in the room was that making such a change was premature.

As the authors finalized their data in June 2012 for a study published that November, Ms. Kaitz underwent her hysterectomy. Mr. Kaitz said his wife, then 51, repeatedly asked about her chance of having cancer as she sought multiple opinions at Brigham before undergoing a minimally invasive hysterectomy for what were thought to be fibroids. Brigham said that according to medical records, one doctor told the couple that cancer was a concern, discussed morcellation risks and recommended an open procedure.

Mr. Kaitz doesn’t recall any discussion of morcellation, and said the doctor “left the impression that cancer was an incredibly remote risk.”

He said the couple was assured further after meeting Jon Einarsson, Brigham’s chief of minimally invasive gynecology. Mr. Kaitz said Dr. Einarsson didn’t mention the risks of morcellation and put his wife’s chance of a hidden cancer at 1 in 10,000, odds Ms. Kaitz thought she could handle.

Through a spokeswoman, Dr. Einarsson said he “believes he likely” put the risk at between 1 in 1,000 and 1 in 10,000. He didn’t recall the specifics of his conversation with Erica Kaitz, but said he explains all surgical risks and benefits to patients.

A few days after her hysterectomy, with power morcellation, Ms. Kaitz learned she had leiomyosarcoma. The morcellation “seeded her abdomen” with cancer and quickly made an aggressive disease even worse, believes Dr. Suzanne George, a sarcoma expert at Dana-Farber Cancer Institute who treated Ms. Kaitz.

Through a spokeswoman, Dr. Einarsson said he is “saddened by the loss of his patient and has expressed his sincere condolences to Mr. Kaitz.”

Brigham shifted its practice after Dr. Reed, the second patient, underwent a hysterectomy with morcellation in October 2013 for a “clearly benign diagnosis” of fibroids, according to her medical records. Afterward, she also learned she had cancer, which now is in remission.

Neither Dr. Muto, who saw Dr. Reed before surgery, nor Dr. Karen Wang, the surgeon, told her of the device’s cancer-spreading risk, Brigham said. The doctors declined to comment on the case. Brigham has suspended use of the device outside of a study.

“Dr. Reed’s case was very important for us,” Dr. Barbieri said. “It suggested that even with careful case selection it would not be possible to ensure that an occult [not detectable beforehand] sarcoma would not be morcellated.”

November 25, 2014

FDA gives surgical tool its strongest warning

By Jon Kamp and Jennifer Levitz

The top U.S. health regulator warned Monday that a common surgical tool shouldn’t be used on most women during hysterectomies, a decision that caps nearly a year of debate and is expected to sharply limit a procedure the agency said can spread hidden cancer.

The Food and Drug Administration used its authority to call for an immediate “black box” warning for laparoscopic power morcellators, the strongest caution the agency issues. Typically, such warnings on product labels undergo a lengthy comment period before being completed, lawyers for device makers said.

“We believe that in the vast majority of women, the procedure should not be performed,” said William Maisel, deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health.

The move strengthens guidance the FDA issued in April and draws tight boundaries around use of a device that divided gynecologists and alarmed women. Morcellators were being used in thousands of minimally invasive procedures every year to remove growths known as fibroids.

While fibroids are benign, they can be hard to distinguish from a dangerous form of cancer called uterine sarcoma, which can’t be reliably detected before surgery. Morcellators, which typically use a spinning blade to cut up tissue so it can be removed through small incisions, can spread the malignancy and worsen outcomes, the FDA said.

The tool was first approved for gynecology in the 1990s but its popularity rose in recent years with the rise of minimally invasive and robotic surgery. The FDA began looking into the issue after a Boston doctor, Amy Reed, went public in a December 2013 Wall Street Journal article that detailed her worsened cancer after a hysterectomy using the device.

About 1 in 350 women undergoing fibroid surgery — which generally involves a hysterectomy — have an unsuspected sarcoma found in later testing, the FDA estimated in April when it discouraged doctors from using the tool after reviewing mounting evidence. The risk, reiterated in Monday’s updated warning, previously had been believed to be far lower.

The new warning falls short of an all-out ban urged by opponents, such as Dr. Reed. “I think the wording is such that no sound practitioner would use it,” said Dr. Reed, a 41-year-old mother of six who now lives in the Philadelphia area. “But there are still people who won’t know who will be at the mercy of their physicians.”

Nonetheless, the warning recommends strict limits on the tool’s use. The agency doesn’t regulate doctors or medical practice, but the warning could raise legal exposure for manufacturers or physicians who act counter to the FDA advice.

“It’s got our risk-management department in a tizzy,” said Christopher Stanley, the medical director at Halifax Health Center for Female Pelvic Medicine in Daytona Beach, Fla., which is still using morcellators. A hospital spokeswoman didn’t dispute Dr. Stanley’s characterization of the reaction and said the hospital is taking a hard look at the FDA’s new statement.

Dr. Stanley said he already was careful with patient selection for the procedure and will follow the FDA guidance.

“If they give you a path, you better have a real good reason for diverting from that path because if anything untoward happens, then how are you going to explain that?” he said.

The FDA said it wanted to leave a window open for the small number of women for whom benefits may outweigh risks. This includes younger women whose fertility could be preserved by removing only the fibroids and not the uterus. Still, the agency said any woman who does undergo the procedure should be warned that morcellation could spread unsuspected cancer.

The 58,000-member American College of Obstetricians and Gynecologists, the main U.S. professional group for the field, said it was pleased with the decision but plans to seek more clarification from the agency on which women may be eligible for the procedure.

“Most women will not have it used, as it should be, but there is still the ability of that rare woman to benefit,” an ACOG spokeswoman said.

Atlanta gynecologist Michael Randell said the announcement is unlikely to change the way he practices. He said he is a frequent morcellator user but specializes in younger patients who still may be morcellator candidates. “It would be wrong for me to abort the morcellator and open those patients up” using traditional surgery, Dr. Randell said.

He said, however, that he expects the decision to have a broad impact. “The story is: bottom line, don’t use a morcellator if you can avoid it,” Dr. Randell said.

Temple University Hospital in Philadelphia — the first among many that halted morcellator use as controversy erupted early this year — doesn’t intend to put the devices back in the operating room, said Enrique Hernandez, its head gynecologist.

Doctors are “taking a gamble with their patients and with themselves” because younger women, despite having a comparatively lower risk than older women, still can have a hidden sarcoma, Dr. Hernandez said.

For some morcellator opponents who wanted an outright ban, the announcement was bittersweet. Though they wanted the agency to go further, Monday’s action showed that their advocacy, including emotional pleas at a two-day FDA hearing in July, made a difference.

“We didn’t get everything but we probably got a lot more than I ever expected,” said Jim Leary, whose wife, Barbara, died in September 2013. A doctor used a morcellator in 2009 to remove what looked like a benign fibroid, but she had cancer.

The FDA called on manufacturers to update product labels with the warning, which advises doctors to tell patients that uterine tissue can contain unsuspected cancer and that morcellators can spread the malignancy and lower longterm survival rates.

Labels also should include two “contraindications,” specific situations or patients where the device shouldn’t be used. Those include women transitioning into menopause or who have gone through it, and women who could have their uterus removed intact through their vaginas or through a so-called mini-laparotomy, which uses a larger incision than a morcellator requires but isn’t considered fully open surgery. Those groups cover most women who would normally have the surgery, the FDA said.

The largest morcellator maker, Johnson & Johnson, left the market after the April safety warning, but other morcellators remain on sale. Several other manufacturers and distributors didn’t respond to requests for comment.

A black-box warning is unusual. The FDA has issued them for drugs including Chantix, a smoking-cessation treatment, out of concern for psychiatric side effects; Lariam, a malaria drug, also for psychiatric side effects; and Yaz, a birth control pill, for women over 35 who smoke, out of concern for blood clots. Such warnings are rarer with devices.

The FDA said it is still considering other steps to reduce the risk of spreading hidden cancers from morcellation, including possible containment systems and improved preoperative detection of cancer. Some doctors have been working to develop surgical bags to surround the morcellation procedure and guard against cancer dissemination. While bags are a reasonable practice for skilled doctors, they can also introduce other risks, Dr. Maisel said.

Brigham and Women’s Hospital in Boston, which has been studying and advocating for using bags with power morcellators, said Monday it has paused a four-hospital, 400-patient bag study to consider the FDA’s new guidance.

Tom Burton contributed to this article.

December 9, 2014

Doctors advise FDA and companies, too

By Joseph Walker

David Kandzari, an Atlanta cardiologist, also has worked as a consultant to makers of medical devices. He received at least $100,000 from them in five years, according to corporate and government data.

Another organization he works with, the Food and Drug Administration, doesn’t appear to mind. In October, the FDA put Dr. Kandzari on a panel reviewing a medical device made by Boston Scientific Corp., one of the companies he has advised.

The FDA didn’t disclose the connection. It was among numerous financial ties the FDA hasn’t disclosed between medical-device makers and the doctors and other experts who review devices for it, a Wall Street Journal analysis of corporate, state and federal data shows.

In panels evaluating devices involved in cardiology, orthopedics and gynecology from 2012 through 2014, a third of 122 members had received compensation — such as money, research grants or travel and food — from medical-device companies, an examination of databases shows.

Nearly 10% of the FDA advisers received something of value from the specific company whose product they were evaluating.

The FDA disclosed roughly 1% of these corporate connections. The situation concerns critics. “Undisclosed conflicts raise questions about the decision-making capacity of the committees and whether the public can have confidence in their recommendations,” said Joseph Ross, an associate professor at Yale School of Medicine.

The FDA follows the committees’ advice in a large majority of instances, on prescription drugs as well as on medical devices. On devices, it has convened more than 20 meetings this year for recommendations on whether to approve novel products or put new regulations on older ones.

The issue arose most recently in July regarding a panel evaluating surgical tools called power morcellators that cut up uterine fibroid growths. A gynecologist stepped down from the panel not long after the Journal inquired about payments he had received from a maker of the devices, a connection the FDA hadn’t disclosed.

The FDA said under current law and policy, it discloses advisers’ financial interests only when it has determined the experts need a waiver in order to serve.

In making this determination, it has discretion. Having done paid work for a medical-device company doesn’t disqualify a doctor or scientist from sitting on an advisory panel, nor require public disclosure, as long as the work wasn’t related to the specific topic or product the panel focuses on, FDA officials said.

Current consulting work that is directly related to a panel topic is typically a disqualifying conflict, as is ownership of a large amount of the device maker’s stock, said FDA Associate Commissioner Jill Hartzler Warner. Still, if the FDA believes the individual’s expertise can’t be found elsewhere, it can issue a waiver.

It posts such waivers on its website. The agency said it can’t reveal any other financial ties or potential conflicts because what its scientific advisers tell it is confidential.

“Our challenge and our goal is to retain public confidence in the advisory-committee process and at the same time to obtain the very best advice,” Ms. Hartzler Warner said.

“If you have a financial interest with a sponsor or a related firm, but it’s not related to the product at the meeting, it’s not disqualifying,” she said. “The firms are often large and diverse, and whatever position the FDA takes, it won’t affect the relationship between the firm and the” expert adviser. Doctors said their consulting work doesn’t affect their panel decisions. “I’ve never sat there on a panel and thought, ‘I wonder what my friends at companies X, Y and Z would say.’ I just don’t view it that way,” Dr. Kandzari said.

In the panel in October, he voted to approve a heart device from Boston Scientific, a firm that has paid him between $5,700 and $8,190 in consulting fees and expenses for food, travel and lodging since 2011, according to company data. The consulting didn’t concern the kind of device the October panel evaluated, so it posed no conflict, he said.

Dr. Kandzari confirmed he has consulted for various device makers. He questioned the accuracy of payment data posted by companies, saying, among other things, that some payments were actually made to his employer.

The Food and Drug Administration, based in the Silver Spring, Md., offices above, uses some advisers on medical devices who have served as device-maker consultants, including Drs. David Kandzari, upper right below, and Andrew Brill; FDA executive Jill Hartzler Warner said the agency seeks to retain public confidence while obtaining the best advice.

As for Boston Scientific, it said that device makers “are not consulted, or engaged in any way in the selection of panel members.”

The FDA said broader disclosure could discourage people from sitting on advisory panels. The agency already has a challenge getting highly qualified experts to sign on, Ms. Hartzler Warner said. Edward Y. Cheng, an orthopedic surgeon at the University of Minnesota Medical School and Cancer Center, said doctors have a strong financial disincentive to serve because they must take time away from their practices.

Among ties not disclosed by the FDA were $6,666 in consulting fees Dr. Cheng received from a maker of all-metal hip implants a year before he sat on a panel evaluating the safety of that type of hip. Dr. Cheng said the work was unrelated to all-metal hips.

Dr. Cheng said it is the FDA’s job to gauge whether a conflict exists but added: “if I personally thought a conflict existed that would affect my ability to remain unbiased, I would decline to participate.” The FDA said it doesn’t comment on individual panel advisers or their finances.

There is no central way for the public to learn of ties between panel members and makers of medical devices or drugs, which pay hundreds of millions of dollars a year to physicians in consulting, speaking and other fees, according to data from the Centers for Medicare and Medicaid Services. Concerns that such ties could affect doctors’ medical decisions have led to calls for greater transparency.

Many large drug and device companies post their payments to doctors online, often as part of legal settlements over fraud allegations. Some states, including Massachusetts and Vermont, post payments to physicians in their areas.

Doctors often must disclose potential conflicts when writing for scientific journals or giving presentations at medical meetings. The federal government this year launched a database called Open Payments, which so far has five months of 2013 data on company payments to doctors and teaching hospitals. The Journal used all these sources as well as archives maintained by PharmaShine, a service of Obsidian Healthcare Disclosure Services LLC.

No database reveals doctors’ and medical scientists’ stockholdings, so any search can give only a partial picture of financial ties.

The Journal’s tally of payments to members of panels on cardiology, orthopedic and gynecology devices in 2014 found that 64% received no value from device makers in the past five years. The rest did, varying from less than $15 for food and beverage to more than $500,000 in research funding. Of doctors who received something from companies, 32% got less than $500 in value and 26% received $10,000 of value or greater.

Before advisory-panel meetings, the FDA asks potential members to report all financial ties, including consulting fees, research grants and stock, in companies with business before the panel and their competitors. In general, if the value of current interests exceeds $50,000, a person will be excluded, said an FDA guidance document.

If the agency decides a payment isn’t truly a conflict, it can issue what is called a “502 authorization” letting the person serve, said Ms. Hartzler Warner.

The 502 authorizations, unlike waivers, aren’t publicly disclosed.

The FDA declined to say how many 502 authorizations it issues annually.

“The problem with the FDA’s policy is you don’t know how they use their discretion,” said Celia Wexler, a lobbyist for the Union of Concerned Scientists, a group that opposes political interference in scientific and regulatory matters.

“It’s very difficult for us to know to what extent the FDA probes, and the extent to which panel members take the disclosure requirements seriously.”

Shortly before the July panel on morcellator surgical devices — which reviewed concerns they could spread hidden uterine cancers — the Journal discovered that panel member Andrew Brill had received nearly $100,000 in consulting fees in 2013 from Johnson & Johnson, then the largest maker of morcellators. The information was on a J&J-run public database, which also shows that another J&J unit paid $6,000 to Dr. Brill in 2013.

Dr. Brill resigned from the panel just before it met. The FDA said he recused himself because of his financial interests with companies. It declined to discuss why it initially appointed him to the panel. Dr. Brill declined to comment.

Documents posted on the website of the American Association of Gynecologic Laparoscopists show Dr. Brill also had ties to another morcellator maker, Karl Storz GmbH of Germany, for which he was a consultant and speaker in 2012.

Another corporate connection the FDA didn’t disclose: Dr. Brill sat on a panel examining risks of surgical mesh products, which are used to support internal organs and treat urinary incontinence, in 2011 — a year when he received $82,600 from J&J subsidiaries, including one that makes surgical mesh. The information is on J&J’s website.

J&J declined to comment. It pulled its morcellators from the market earlier this year. Karl Storz didn’t respond to requests for comment.

Keith Isaacson, a doctor who served on the morcellator panel, had received nearly $12,000 in consulting fees from a J&J subsidiary in 2013, the Journal reported in July. Further review of databases shows that Dr. Isaacson also got $9,500 from J&J from 2010 through 2012 for consulting, food and education and training; and that he received $148,400 in consulting fees and other compensation from Karl Storz from 2009 through 2013.

The information came from websites of J&J, a Massachusetts health agency and Open Payments.

At the panel’s meeting, Dr. Isaacson expressed doubt about data showing that women getting surgery for fibroids have a 1 in 350 chance of having malignant tumors that morcellators could spread, a panel transcript shows. He noted a recent study that found the risk was closer to 1 in 7,450.

Dr. Isaacson declined to comment. The FDA wouldn’t discuss the payments or why it placed Dr. Isaacson on the panel in view of these corporate ties.

Dr. Kandzari, the cardiologist who served on an October FDA panel evaluating a heart device, is the director of interventional cardiology and chief scientific officer at Piedmont Heart Institute in Atlanta. He has published many medical-journal articles. He said his consulting for device companies is aimed at helping firms design more-efficient clinical trials.

One FDA panel Dr. Kandzari sat on last year considered a pacemaker and a defibrillator made by Medtronic Inc. That is a company from which Dr. Kandzari received between $76,600 and $130,600 for consulting work, teaching, travel, lodging and meals from 2010 through 2013, according to company and federal databases. A panel transcript shows he abstained from voting on whether to approve expanded

use of the devices because he wasn’t sure whether the benefits outweighed the risks.

Dr. Kandzari said his past consulting for Boston Scientific, the maker of the device that was being evaluated at the October panel, had concerned an arterial stent. The October panel focused on a different Boston Scientific product: a plug that seals a heart appendage to cut the risk of strokes caused by clots.

That plug, called the Watchman, had been backed by previous FDA panels but was being reviewed again because a study showed patients receiving it had more strokes caused by blood clots than patients getting the blood thinner warfarin.

While the panel in October deemed the device safe, a narrow majority that included Dr. Kandzari judged it not as effective as warfarin. Still, he voted yes in a 6-5 panel vote concluding its benefits outweighed its risks, tantamount to a recommendation of marketing approval.

Dr. Kandzari said despite his concerns that “stroke was not necessarily reduced with this technology,” he believed it should be available for patients who are at high risk of complications from warfarin.

Following the advisers’ vote, Boston Scientific told analysts it expected the Watchman to win FDA approval in the first half of 2015 and eventually reach $500 million in yearly sales.

Andrea Fuller contributed to this article.

Cover letter for entry

To the judges:

Journalism can do no greater public service than to save a life.

The Wall Street Journal’s alarming revelations about a once common medical procedure had this powerful and lasting impact. After nearly a year of Journal reporting, the U.S. Food and Drug Administration imposed its strongest restriction on the device used in the procedure and said it shouldn’t be employed in the vast number of cases. Doctors and hospitals curbed or abandoned the practice. Johnson & Johnson, the top manufacturer, pulled the device off the market. And women undergoing surgery were now armed with information that, for many, could determine life or death.

The coverage emerged from a front-page Journal story in December 2013 about new concerns over hysterectomies, a surgery that 500,000 American women undergo every year. A Boston doctor, who was also interviewed in the Boston Globe, believed her uterine cancer had been spread by a device called a laparoscopic power morcellator, which is used for minimally invasive hysterectomies. Like most U.S. medical devices, the morcellator was approved for use without clinical trials. The tool has helped speed recovery times and reduce scarring when compared with a conventional hysterectomy. But the Journal, which spent weeks reporting that first story, showed some doctors were concerned that their field had significantly underestimated the dangers of the device, and research suggested they could be right.

That article laid the groundwork, and the Journal set out in 2014 to determine the truth. The most common reason for a hysterectomy is to treat a benign condition known as uterine fibroids. But fibroids can be misdiagnosed. What appears to be a run-of-the-mill gynecological problem can sometimes be a dangerous cancer that cannot be reliably detected before surgery. The morcellator fragments tissue so it can be removed through small incisions. But in so doing, it also scatters the hidden malignancy into the abdominal cavity—effectively helping it metastasize. As a result, survival rates plunge.

The Journal’s series of articles included a deep dive that brought to light the morcellator’s unique rise in gynecology, the widespread underestimation of the cancer risk associated with fibroids, and the disturbing fact that most doctors never told patients a morcellator would be used or had the possibility of spreading cancer. Less than a week after the Journal’s article, the FDA raised its estimate of the presence of cancer in women undergoing surgery for fibroids and warned doctors that the morcellator could worsen a patient’s prognosis. In another front-page story, the Journal revealed that many gynecologists considered the April warning government overreach and continued to use the device.

An extensive team of Journal reporters, editors, video producers and social media managers, ranging from London to New York to Washington, D.C., tackled the story. They found startling data in meta-studies and documents that had been ignored. They pursued hidden federal information through Freedom of Information Act filings. They published dozens of stories — including 10 on the Journal’s front page — and held online Q&A discussions with readers. And to reach an even wider audience, they published a 6,000-word free ebook on morcellators, titled “Deadly Medicine,” during Gynecologic Cancer Awareness Month in September.

Most of all, they told the stories of patients, doctors, lobbyists, companies and regulators.

The Journal revealed in another front-page article that the FDA was aware of the risk of spreading cancer when it first approved the morcellator for gynecology in the 1990s. After the Journal reported that a doctor on an FDA advisory panel for morcellators had accepted nearly $100,000 in consulting fees from manufacturers of the device, the doctor resigned from the panel. The Journal then followed up with an extensive report on similar conflicts on FDA device panels.

Then there was the story about Colorado college instructor Debra Grymkoski. She said she was prompted by the Journal’s reporting to tell her doctor not to use a morcellator in her hysterectomy. He reluctantly agreed. Ms. Grymkoski learned after the surgery she had uterine sarcoma. “I walked away from that almost dumbfounded,” her doctor, Stephen Wassinger, told the Journal. “Using a morcellator would have saved me 30 minutes of surgery, but it would have ultimately been much worse for her prognosis.”

In November, the Journal told the story of Linda Interlichia, Barb Leary and Brenda Leuzzi, three Rochester, N.Y., women who died of cancer after the procedure. “My most fervent wish is to make sure this never happens to anyone else,” Ms. Interlichia told the Journal weeks before she died. The chief of obstetrics and gynecology at Halifax Health, a Florida hospital that was still using morcellators, found a copy of that story on his desk with a note from the hospital CEO. Its message: “We need to talk.”

Three days after the story appeared, the FDA issued its strongest possible caution for the morcellator: an immediate “black-box” warning. The device, the FDA said, shouldn’t be used on the “vast majority of women.”

Americans place their trust in medicine, often at the most vulnerable time in their lives. The story of the morcellator demonstrates a betrayal of that trust. Doctors and companies evangelized for the device without fully considering the risks or informing patients. The government agency responsible for the safety of medical devices ignored its own internal concerns. Women went into surgery believing they had a simple, benign condition and emerged facing a battle for their lives.

The Journal’s coverage in 2014 revealed this betrayal. It unmistakably altered the course of medicine and saved the lives of an untold number of women. I am proud to nominate this series for the Pulitzer Prize for Public Service.

Sincerely,

Gerard Baker

Winners

Prize Winner in Public Service in 2015:

The Post and Courier

For "Till Death Do Us Part," a riveting series that probed why South Carolina is among the deadliest states in the union for women and put the issue of what to do about it on the state's agenda. Public Service

Finalists

Nominated as finalists in Public Service in 2015:

The Boston Globe

For its stories, videos, photos and graphics exposing a poorly regulated, profit-driven housing system that subjected thousands of college students in Boston to unsafe, and even deadly, conditions.

The Jury

Scott Kraft(Chair )

deputy managing editor

Rebecca Blumenstein

deputy editor-in-chief

Robin Fields

managing editor

Martin Gottlieb

editor

Josh Meyer

director of education and outreach, National Security Journalism Initiative

Sandy Sugawara

managing editor

Rene Sanchez

editor and senior vice president

Winners in Public Service

2014

The Guardian US

For its revelation of widespread secret surveillance by the National Security Agency, helping through aggressive reporting to spark a debate about the relationship between the government and the public over issues of security and privacy.

2013

Sun Sentinel

For its well documented investigation of off-duty police officers who recklessly speed and endanger the lives of citizens, leading to disciplinary action and other steps to curtail a deadly hazard.

2012

The Philadelphia Inquirer

For its exploration of pervasive violence in the city's schools, using powerful print narratives and videos to illuminate crimes committed by children against children and to stir reforms to improve safety for teachers and students.

2011

Los Angeles Times

For its exposure of corruption in the small California city of Bell where officials tapped the treasury to pay themselves exorbitant salaries, resulting in arrests and reforms.

See All Public Service

2015 Prize Winners

Fiction

Finalist: The Wall Street Journal, by The Wall Street Journal

Nominated Work

Cancer Concern Over Uterine Procedure Prompts Split in Medical Community

Morcellators, Used in Uterine Procedures, May Spread More Types of Malignancy, Study Finds; Report Backs FDA’s Concern

Winners

The Post and Courier

Finalists

The Boston Globe

The Jury

The Jury

Scott Kraft(Chair )

Rebecca Blumenstein

Robin Fields

Martin Gottlieb

Josh Meyer

Sandy Sugawara

Rene Sanchez

Winners in Public Service

The Guardian US

Sun Sentinel

The Philadelphia Inquirer

Los Angeles Times

2015 Prize Winners

Anthony Doerr

Julia Wolfe

Stephen Adly Guirgis

David I. Kertzer