Bayer Essure: Failure to Inform Patients of Harm or to Follow Patient Outcomes

Bayer’s Essure Contraceptive Implant, Now With a Warning

By RONI CARYN RABIN            NOVEMBER 21, 201

Kim Myers used to compete in rodeo-style barrel horse races, but after being sterilized with an implantable device called Essure, the pain was so intense that she had to stop.

The device’s small metal and polyester coils had pierced her fallopian tubes, her doctor found, so the two implants were removed. But the sharp, laborlike pains didn’t really subside until three years later, when Ms. Myers had a hysterectomy.

Then her surgeon discovered the cause: A piece of metal coil was still embedded in her uterus.

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Kim Myers, 53, in the stable at her home in Wesson, Miss. Even after her two Essure implants were surgically removed, her sharp pains didn’t subside until she had a hysterectomy.

EDMUND D. FOUNTAIN FOR THE NEW YORK TIMES

“Doctors kept saying there was nothing wrong with me,” said Ms. Myers, 53, of Wesson, Miss. “I knew, with every fiber of my being, there was still something there.”

Ms. Myers was among a parade of women who testified before the Food and Drug Administration 14 months ago, saying they’d been injured by Essure and urging officials to pull the device from the market.

Essure comprises two small coils, made of a nickel alloy and a polyesterlike fiber, placed in the fallopian tubes through the vagina. The coils are designed to provoke an inflammatory response that causes scar tissue to form and block the tubes, a process that can take three months.

F.D.A. officials declined to withdraw the device, saying that Essure was safe and effective for many women although some experienced “very serious and sometimes debilitating problems.” But last week the agency ordered that a so-called black box warning be placed on the device’s packaging saying it could cause the kinds of injuries Ms. Myers sustained.

The implant may puncture the fallopian tubes and uterus, and travel into the abdomen and pelvic cavity, the warning notes, causing persistent pain and requiring surgical removal.

Officials at Bayer, which makes and sells Essure, say poor surgical skills are to blame for complications like Ms. Myers’s and insist there is no proof the device causes other reported side effects like chronic pain and autoimmune disorders.

“These are so common to women,” said Dr. Edio Zampaglione, Bayer’s vice president for United States medical affairs.

The F.D.A. also took the unorthodox step of guiding Bayer in the development of a new checklist of risks for doctors to review with patients before implanting the device. The three-page checklist is broken into five sections, each followed by a spot for the patient’s initials, and is to be signed by both doctor and patient.

The checklist is not mandatory, and critics say it does not mention many common side effects linked to Essure, like heavy, painful menstrual bleeding.

Some doctors complain that the checklist is intrusive and burdensome, may dissuade physicians from using the implants, and is based on anecdotes rather than scientific clinical trial data. Some providers, including Planned Parenthood, have said they will inform patients of the risks and benefits, but not ask them to sign the document.

“There’s no question there are complications, but there are risks and benefits to everything we do in medicine, and we don’t have good data to establish the magnitude of the problem,” said Dr. Christopher M. Zahn, the vice president of practice for the American College of Obstetricians and Gynecologists.

“Decisions like these should be made based on data that’s appropriately vetted, not a series of anecdotal reports,” Dr. Zahn said, referring to the black box warning and the checklist.

Dr. Zampaglione of Bayer noted that some studies had shown that other methods of permanent sterilization, not just Essure, have caused serious long-term adverse events as well.

The F.D.A. approved the implant in 2002 after a fast-track review process that prioritized the device because it was the first sterilization procedure for women that could be done in a doctor’s office, without an incision and without general anesthesia. It offered an option to tubal ligation, commonly known as having one’s “tubes tied.”

Pain and other serious side effects emerged in the clinical trials of Essure. The device could not always be implanted, and failed to block the tubes in a significant percentage of patients. According to the new checklist, nearly one in 10 women who try Essure cannot rely on it to prevent pregnancy.

The F.D.A. approved Essure after trials lasting a year or two, even though the implant was meant to last for life. By the end of last year, the agency had received nearly 10,000 reports of injuries and pregnancies related to the device, as well as reports of a very small number of fatalities.

Many doctors who insert the implant do not know how to remove it.

By contrast, drug trials are required to have a comparison group of participants who are given a placebo.

Earlier this year, Bayer agreed to begin tracking 1,400 women who have the device implanted over the next five or six years. The study is supposed to report final results in 2023, but is already behind schedule.

This study has a comparison group of sorts: It will also follow 1,400 women who choose a more traditional form of sterilization using laparoscopic surgery.

The women will be followed for three years after the sterilization procedures to see how many in each group develop complications like chronic pelvic pain, heavy bleeding and autoimmune disorders, as well as how often each intervention fails, leading to pregnancy.

Researchers will also track how many women with Essure develop such severe complications that they have to undergo surgery to remove the implants.

http://mobile.nytimes.com/2016/11/21/well/bayers-essure-contraceptive-implant-now-with-a-warning.html?referer=https%3A%2F%2Fwww.google.com%2F

NYT Editorial: FDA/CDRH STOP Bayer Essure Harm!

Safety Questions About a Birth Control Device

By THE EDITORIAL BOARD OCT. 14, 2015

The Food and Drug Administration convened a panel of experts last month to examine the safety and effectiveness of a device for permanent birth control that has generated thousands of complaints from women who say they were harmed by it.

The device, known as Essure, is implanted in a woman’s fallopian tubes to induce scar tissue formation to block the tubes and prevent eggs from being fertilized. It is an alternative to procedures that tie or cut fallopian tubes, and some 750,000 women have received the device around the world, mostly in the United States.

The American College of Obstetricians and Gynecologists considers Essure as effective as surgical procedures and safer in some respects. Planned Parenthood considers it an important option.

More than 5,000 women have reported harmful effects to the F.D.A. (this is very likely an undercount since many problems go unreported). According to the advisory committee’s summary, patients have reported persistent pain, bleeding, allergic reactions and the need to remove a faulty device and repair any damage. There have also been hundreds of unwanted pregnancies. The risks of removal are unknown because various techniques have not been evaluated in clinical studies. Many women out of desperation had hysterectomies, which they said eased their symptoms.

In addition to these complaints, a petition has been submitted to the F.D.A. by a Florida law firm claiming that the small company that developed the device committed fraud by manipulating data in the clinical trials that led to F.D.A. approval. The F.D.A. sent the complaint to its own compliance office. That is not good enough. The charges need to be investigated by an independent office free of influence from the F.D.A., like the inspector general of the Department of Health and Human Services.

The manufacturer, Bayer HealthCare Pharmaceuticals, which acquired the device in 2013, argues that the percentage of women reporting problems is low and that many of the problems are unrelated to the device.

All birth control measures carry risks and benefits. What women and doctors need to know is how this device compares with surgical procedures and intrauterine devices in preventing pregnancies and causing minimal harm. The F.D.A. needs to look hard for ways to get that information and should consider suspending sales of Essure until better data is available.

http://nyti.ms/1ZDcQCZ

Bayer Essure 'birth control' device had a WARRANTY!

 

Conceptus(R) Introduces the Only Patient Reliance Warranty for Permanent Birth Control

Essurance Promise (TM) Program Confidently Demonstrates the Essure(R) Procedure's Unprecedented Performance

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May 02, 2011 09:00 ET | Source:  Conceptus, Inc.

MOUNTAIN VIEW, Calif., May 2, 2011 (GLOBE NEWSWIRE) -- Conceptus, Inc. (Nasdaq:CPTS), developer of the Essure^® procedure, the most effective permanent birth control method available, today introduced the Essurance Promise^™ Program, the industry's first-ever patient reliance warranty program, at the American College of Obstetricians and Gynecologists 59th Annual Clinical Meeting.

The Essurance Promise^™ Program is an exclusive "out-of-pocket" payment assistance program for the Essure Confirmation Test. After a patient has had the Essure procedure and both inserts are successfully placed, she returns for her Essure Confirmation Test three months later. If she is told by her physician that the Essure procedure requires more time to be effective or she cannot rely on Essure for permanent birth for any reason at that time, the Company will pay her uncovered costs for the Essure Confirmation Test, up to a maximum of $150 per test, and in accordance with certain conditions. 

Conceptus is uniquely able to offer such a warranty program because the Essure procedure's clinical and real-world commercial performance is unsurpassed among all other permanent birth control options, including tubal ligation, vasectomy and the only other competing hysteroscopic sterilization product. For nearly a decade of clinical trial follow-up, there have been zero reported pregnancies with the Essure inserts when properly placed. Results in the commercial setting over this same time period are equally compelling and continue to reflect the Essure procedure's superb clinical performance. 

No other method of permanent birth control works better than the Essure procedure and no company other than Conceptus backs up their procedure with a reliance warranty, which gives women full confidence in this birth control choice.

"The Essurance Promise^™ Program is an innovative solution demonstrating our conviction that patients can rely upon Essure for permanent birth control. The warranty supports both physicians and patients by giving them peace of mind when they choose the Essure procedure, while emphasizing the importance of the Essure Confirmation Test," said Mark Sieczkarek, president and chief executive officer of Conceptus. "This program further advances our leadership role in the hysteroscopic permanent birth control market that we pioneered more than a decade ago."

The Essure procedure is the market leader between two competing hysteroscopic sterilization procedures and has been trusted by more than half a million women since 2002.  Following the introduction of the competitor's product last year, the market may have experienced confusion and lack of clarity regarding the differences between the two products. The Essurance Promise Program underscores Essure's unparalleled performance, including the fact that the competitor product's failure rate is 10 times higher than Essure's failure rate, based on three-year clinical data. In addition, Essure clinical trial patients have experienced zero reported pregnancies, while the competitor's product has resulted in 12 pregnancies in patients followed for five years. The Essure procedure has a proven clinical and commercial track record, but the competitor's product has yet to establish and report its long-term clinical and real-world, commercial safety and effectiveness.

A key competitive advantage of the Essure insert is its stainless steel/Nitinol inner/outer coil design, which is radiopaque and allows for visual confirmation of each insert's proper placement both during the procedure and during the Essure Confirmation Test. The competitor's insert is neither visible during the procedure nor during the confirmation test.  

"The Essurance Promise Program is unprecedented for a permanent birth control procedure. Essure is backed by a growing body of scientific data validating the optimal design characteristics and clinical performance of Essure's Nitinol coil insert, both in the FDA trials and the clinical evidence reported in the literature over the past decade," said Barbara Levy, M.D., Medical Director for Conceptus.  "I highly recommend that OBGYNs talk to their patients about the Essure procedure and the Essurance Promise Program."

Additional information on the Essurance Promise^™ Program

Federal Law prohibits any company from offering this kind of program to Medicaid or Medicare patients and is also restricted where prohibited by law. Complete program details can be found on the Conceptus physician website www.essuremd.com.

About the Essure^® Procedure

The Essure procedure, FDA approved since 2002, is the first permanent birth control method that can be performed in the comfort of a physician's office in less than 10 minutes (average hysteroscopic time) without hormones, cutting, burning or the risks associated with general anesthesia or tubal ligation. Soft, flexible inserts are placed in a woman's fallopian tubes through the cervix without incisions. Over the next three months, the body forms a natural barrier around and through the inserts to prevent sperm from reaching the egg. Three months after the Essure procedure, a doctor is able to perform an Essure Confirmation Test to confirm that the inserts are properly placed and the fallopian tubes are fully blocked, giving the patient reliance on Essure for permanent birth control.

The Essure procedure is 99.95% effective based on one year of follow up with zero pregnancies reported in clinical trials, making it the most effective form of permanent birth control on the market. The procedure is covered by most insurance plans, and when it is performed in a doctor's office the cost to the patient may be as low as a simple co-pay. Essure has been proven and trusted by physicians since 2002, with more than 500,000 women worldwide having undergone the Essure procedure.

About Conceptus, Inc.

Conceptus, Inc. is a leader in the design, development, and marketing of innovative solutions in women's healthcare. The Company manufactures and markets the Essure procedure. The Essure procedure is available in the United States, Europe, Australia, New Zealand, Canada, Mexico, Central and South America and the Middle East. The Company also promotes the GYNECARE THERMACHOICE^® Uterine Balloon Therapy System by ETHICON^™ Women's Health & Urology, a division of Ethicon, Inc., in U.S. OB/GYN physician offices.

The Conceptus, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=7961

Please visit www.essure.com for more information on the Essure procedure. Patients may call the Essure Information Center at 1-877-ESSURE-1 with questions or to find a physician in their area.

© 2011 Conceptus, Inc-- All rights reserved. Conceptus, Essure, Essurance Promise and Your Family is Complete. Your Choice is Clear are registered trademarks and service marks of Conceptus, Inc.                                                                                                                    

CC-2749 27APR11F

Investor Relations and Public Relations Contact:
Cindy Klimstra
(650) 962-4032

- See more at: http://globenewswire.com/news-release/2011/05/02/445842/220416/en/Conceptus-R-Introduces-the-Only-Patient-Reliance-Warranty-for-Permanent-Birth-Control.html#sthash.GdM5APMu.dpuf

Bayer Essure: PREVENTABLE failure.

Long-Term Data on Complications Adds to Criticism of Contraceptive Implant

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By RONI CARYN RABIN  The New York Times    (FiDA highlight added)

MAY 3, 2015

When a new contraceptive implant came on the market over a decade ago, it was considered a breakthrough for women who did not want to have more children, a sterilization procedure that could be done in a doctor’s office in just 10 minutes.

Now, 13 years later, thousands of women who claim they were seriously injured by the implant are urging the Food and Drug Administration to take the device off the market and to warn the public about its complications.

Troubling long-term data on women using the device, called Essure, was published on Friday after an unusual eight-year delay. Several patients have sued Bayer HealthCare Pharmaceuticals, and representatives of patient groups plan to meet with officials of Bayer, the manufacturer, on Tuesday to discuss their concerns.

The device is a small metal and polyester coil placed into a woman’s fallopian tubes in order to make her permanently sterile. The F.D.A. approved Essure after a fast-track review process that prioritized the device because it offered the first alternative to surgical sterilization and promised a quick recovery.

Since then, the agency has received more than 4,000 reports of serious complications related to the device, including severe back and pelvic pain, heavy prolonged menstrual periods, and coils that pierced the fallopian tubes and lodged  in other organs.

According to a citizens’ petition filed with the F.D.A., an inspector was given records of 16,047 complaints made to the original manufacturer, Conceptus, between 2011 and 2013, when Bayer acquired a majority interest in the company. Both the agency and Bayer say Essure’s benefits outweigh the risks.

Essure is sold in at least 23 countries, Bayer officials say, and about 750,000 devices are in use worldwide. Company officials declined to say how many American women use Essure, but said serious complications were relatively rare.

“There are no signals, nothing that would indicate a problem with Essure,” said Dr. Edio Zampaglione, vice president for United States medical affairs  and women’s affairs at Bayer. “The events being reported and seen are expected for this type of procedure.”

But in interviews with more than a dozen patients, many said the risks were anything but expected.

Angie Firmalino, a 42-year-old mother of four in Tannersville, N.Y., said she had experienced severe pain and nonstop bleeding for two years after receiving the implant in 2009.

Eventually doctors discovered that the coils had somehow lodged in her uterus and had broken apart. She has had several operations, including a hysterectomy, to remove the fragments.

In 2011, Mrs. Firmalino created a Facebook page to warn friends and family about the device. The page now has nearly 17,000 members.

“If I had any idea of the possible consequences of Essure, I would never have chosen it,” said Mrs. Firmalino, who still takes ibuprofen daily to manage her pain.

In 2000, Kim Hudak was a 28-year-old mother with a 7-year-old son when she volunteered to participate in an early trial of the device. But as soon as she received the implant, she said, she developed a sharp pain in her right hip that did not go away. Her menstrual periods became very painful, and she developed a slew of symptoms including fatigue, migraines and joint pain that often kept her from working full time.

“It felt like I had a really severe case of the flu, and those were the good days,” said Ms. Hudak, now 43, who works in sales in Cleveland. “I had years and years of doctors telling me I was crazy.”

Ms. Hudak has filed a $1 million claim against Bayer seeking reimbursement for injuries and lost wages.

Yet many women do well with Essure and recommend it.

“I had it done during my lunch hour, and I ran a half-marathon shortly afterward,” said Cindy Dossett, 54, of Newburgh, Ind.

She required another procedure to curb menstrual bleeding after getting the implant, but over all, she said, “it’s a pretty easy process.”

Essure was the first device to offer women an alternative to tubal ligation (commonly known as having one’s “tubes tied”) and, as such, was considered a game changer, experts said.

The small coils are placed in the fallopian tubes vaginally, without a surgical incision and with minimal anesthesia.

Once inserted, the coils — made of a nickel titanium alloy and a polyesterlike fiber called polyethylene terephthalate, or PET — trigger an inflammatory response, causing scar tissue to form and block the fallopian tubes, preventing sperm from reaching an ovum. The scarring process can take three months, and women must use other contraceptives until testing confirms the tubes are blocked.

But pain and other serious side effects emerged early in clinical trials required for approval.

In a safety trial that enrolled 269 women ages 23 to 45, the device was successfully inserted into 200 patients. In nine of them, a coil perforated the fallopian tube, was expelled or lodged elsewhere in the body, according to a 2003 report in the journal Human Reproduction.

Trial participants were asked to keep diaries, and nearly one in 10 participants recorded painful intercourse, while one in eight had painful menstrual periods during the first three months.

In a subsequent trial of 518 women, only 449  were able to rely on the device. On 21 occasions, the implant perforated the fallopian tubes, was expelled, or ended up in the wrong place in the body. At least eight women had surgery to be sterilized or to remove a misplaced coil.

Participants again reported back pain, abdominal pain and pain with intercourse.

At the time, F.D.A. officials were concerned that the trials had followed women only for a year or two, while the implant was meant to last a lifetime. The agency approved Essure in 2002 on condition that the investigators continue to monitor the women who participated in the trials for four more years.

The F.D.A. said only 171 women in the smaller trial were followed for five years. A heavily redacted report, posted on the F.D.A. website, shows that five women had hysterectomies and that at least one became pregnant.

Participants reported 270 adverse events, including dozens involving pain and heavy menstrual periods. The investigators determined that only 17 of these were caused by Essure and attributed the rest to other factors. They concluded that pain and bleeding were therefore rare among users.

Although the monitoring period ended in 2007, long-term data on women in the larger trial was published only last week in the Journal of Minimally Invasive Gynecology.

Of the original 518 participants, whose average age was 31, only 366 — about 70 percent — were followed for the full five years.

Fifteen women had hysterectomies. The investigators concluded that only two of these major operations were “possibly” related to Essure.

Thirty-eight percent experienced unusually heavy periods on a recurring basis. One in 20 patients had recurrent pelvic pain, one in 15 had recurrent painful periods, nearly one in 25 had recurring pain with intercourse. Investigators said just one had persistent pain, however.

Because there is no other device like Essure on the market, and because Bayer will not say how many American women have it, experts find it difficult to judge whether the risks are disproportionate. Manufacturers are not required to include control groups in clinical trials, as is standard in drug trials, so there is no comparison group.

F.D.A. officials said they were concerned about the coils moving outside the fallopian tubes, but did not believe the device was flawed.

“The agency believes the benefits outweigh the risks in appropriately selected patients who are adequately informed,” said Dr. William Maisel, deputy director for science and chief scientist in the F.D.A.’s Center for Devices and Radiological Health.

Dr. Zampaglione said women who underwent surgical sterilization were also more likely than other women to undergo hysterectomy. A 1998 study of women undergoing surgical sterilization in the 1970s and ’80s also found high rates of subsequent hysterectomies, he said.

The slowly accumulating data and patient reports, however, have made other experts uneasy.

The National Center for Health Research, a nonprofit group, has begun analyzing adverse event reports related to Essure, looking for patterns of complications.

“The fact that 16,000 women with children and a lot of things to do are willing to take the time to talk about this is very, very unusual,” said Diana Zuckerman, president of the group, referring to Mrs. Firmalino’s Facebook page. “I can’t think of another device like this.”

Dr. Aileen Gariepy, an assistant professor of obstetrics, gynecology and reproductive sciences at Yale School of Medicine, has calculated that nearly one in 10 women with Essure would get pregnant over a 10-year period, a much higher rate than that among women who undergo tubal ligation.

She finds it troubling that the long-term study published last week did not include data on 30 percent of the trial participants.

In clinical trials, she said, “the most common reason patients are lost like this is because they had a problem.”

Physicians familiar with Essure are now deeply divided. Many use it regularly and say they have had tremendous success.

“It’s the best thing out there,” said Dr. Jeffrey Bittner, a gynecologist in Ottumwa, Iowa. “It’s easy, it’s safe, it’s effective — it’s hard to beat. A doctor who doesn’t tell patients that is not being honest.”

Others have become disillusioned.

“When Essure came out, I was very enamored by it and did a lot of Essures all the time, until I started seeing patients come back with problems and referred to me with complications,” said Dr. Mitchell D. Creinin, professor of obstetrics and gynecology at U.C. Davis Health System in Sacramento.

“It’s a great technology. I’m just not sure it’s ready for prime time.”

http://mobile.nytimes.com/2015/05/04/us/long-term-data-on-complications-adds-to-criticism-of-contraceptive-implant.html?_r=2&referrer

Sign this petition to have all surgical mesh reclassified to high risk!

https://actionnetwork.org/forms/tell-the-fda-reclassify-all-mesh-as-high-risk


Many thanks!

J&J $100,000 conflicted FDA panel member on morcellator device?

	JjrkCh #morcellator First speaker at #fda Advisory today defended #surgical mesh at Batiste trial in Dallas: http://t.co/L3HoWtjxeO 7/10/14, 8:06 AM
	JjrkCh #morcellator #fda More on Piet Hinoul at Batiste surgical mesh trial. http://t.co/AklVXmrvfx 7/10/14, 8:09 AM

http://online.wsj.com/articles/doctor-quits-uterine-device-safety-panel-over-conflict-1405013226

U.S. NEWS

Doctor Quits Uterine-Device Safety Panel Over Conflict

Move Comes Before Hearing on Cancer Risk From Morcellation Procedure

By JENNIFER LEVITZ And JON KAMP CONNECT

Updated July 10, 2014 3:25 p.m. ET

SILVER SPRING, Md.—A member of an independent panel weighing 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 had 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 spokesman said. Dr. Brill didn't respond to requests for comment.

In 2013, he received nearly $100,000 in consulting fees from Ethicon, a Johnson & Johnson JNJ -0.08% subsidiary that is by far the largest manufacturer of a tool known as a laparoscopic power morcellator. The advisory panel is expected to make a recommendation to the FDA about whether morcellators, used in an estimated 50,000 hysterectomies a year, should be more tightly regulated or even used at all.

"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 spokesman 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, the only manufacturer that releases names of its paid consultants, said Dr. Brill has done professional education consulting for them in their women's health and energy businesses and that he is a recognized leader in the field.

At least two other gynecologists on the panel have had financial ties to manufacturers, according to J&J's website and other public documents. The FDA declined to release its own disclosure statements submitted by panel members, citing privacy laws for advisory-committee members.

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.

Keith Isaacson, a Boston gynecologist, received nearly $12,000 in consulting fees from Ethicon in 2013. His work for the company has been as a "professional-education consultant," a J&J spokesman said. A spokesman for Dr. Isaacson wasn't available for immediate comment.

Both doctors remain on the panel.

Laparoscopic power morcellators are used to cut up common uterine growths called fibroids, often in a hysterectomy, so they can be removed from the body through small incisions. But in some instances, the devices can spread a rare but dangerous 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 drew a crowd of patients, relatives, doctors and industry representatives.

"Because morcellation upstaged her cancer, Elizabeth never had a chance," Joanne Jacobson told the panel about 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, sitting in the audience with her family, plans to speak Friday.

The head of the influential American College of Obstetricians and Gynecologists argued that taking away morcellators will drive more women to elect open abdominal surgery, which carries its own risks, such as bleeding and infection. "It is unacceptable that in an effort to avoid one risk, we subject women to another," ACOG Chief Executive Hal C. Lawrence III told the panel.

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

He also argued against tougher regulation, which the panel is expected to discuss Friday. Dr. Hinoul urged instead efforts to better identify women who could be more at risk of harboring cancer. The cancer can't be reliably detected before surgery.

Write to Jennifer Levitz at jennifer.levitz@wsj.com and Jon Kamp at jon.kamp@wsj.com