Plastic Mesh Surgically Implanted in Mothers: What Could Go Wrong?

“I was rotting from the inside”: The vaginal surgery secretly destroying mothers’ lives.

MICHELLE ANDREWS

April 28, 2017  FiDA highlight

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Kim Blieschke had no idea her life would change irreparably when she was advised to undergo a “straightforward” surgery to correct pelvic organ prolapse – a complication from childbirth that results in surrounding organs to bulge or sag down into the vagina.

But moments after waking up from her transvaginal mesh implant procedure in 2006, where a web of polypropylene plastic was embedded into her vaginal wall, the mum-of-four knew “something wasn’t quite right”.

“I was in intense pain that they couldn’t control,” Kim told me over the phone from her Port Pirie home, in the South Australian countryside.

“I woke up with quite substantial bruising all over my buttocks and perineum and upper thighs. The bruises were the size of my hand.”

"I had necrotic flesh in there." (Image supplied)

"It was a pain like you wouldn't believe," she said. "Doctors said I'd be in the hospital for two or three days, but I was there for seven. On the three-hour car ride home, sitting was almost unbearable."

From there, Kim's condition spiralled.

"My doctor kept saying it will be better, it will be better, but I ended up taking three months off work," she told me. "I couldn't drive, I couldn't lift, I couldn't even sweep the floor."

Doctors made Kim feel like she was imagining the pain, but as a seasoned paramedic, she knew something was awry when her vagina developed a "foul smell".

"I told my GP something wasn't quite right, and it turned out I had necrotic flesh in there."

The polypropylene - a material used to create everything from plastic chairs to water bottles - had ignited Kim's natural foreign body reaction. Her body wasn't just trying to fight the mesh, it was trying to kill it.

The Therapeutic Goods Administration says transvaginal meshes were approved by "conformity assessment certification either from a EU certification body or the TGA".

By 2014 the TGA admitted its assessment process for the mesh was not “mature” and lacked “rigour”, and subsequently announced there was “little evidence to support the overall effectiveness of these surgical meshes as a class of products”.

By 2015 - a decade after mesh was first approved for embedding within the vaginas of thousands of Australian women - 72 of the 100 mesh products on the Australian market were delisted.

Despite this, where the TGA acknowledged shortcomings of the devices, it mostly blamed "the skill and training of the surgeon and the patient selection".

While the TGA said in a statement to Channel 10 it has only received 205 adverse event reports, and "the reported rate of complications was low", Kim argues this is because the channels of reporting post-surgical problems is convoluted and lacks transparency.

The implant that Kim was told to not worry about, the one she was told was simple and straight forward, was eroding away, and destroying her body with it.

"I felt like I was rotting from the inside," she describes.

By the time 2013 rolled around - some seven years after Kim's surgery - her surgeon had retired. The South Australian mum had developed chronic nerve damage which consumed her right hip, knee and two of her toes.

The fetid mesh was deeply affecting her sex life with longterm partner Jared, too.

"When I had intimate relations with my partner, he could feel the hard and brittle arms of my implant against him. It was unbearable.

"A lot of women's partners and husbands have just walked away and left them because of the impact it has on their sex lives, but thankfully my partner has been wonderfully supportive."

The "disastrous" effect the mesh has had has seen Kim spend "hundreds of thousands of dollars", take months at a time off work, and use up all of her long service leave just to find some relief from the constant pain.

Because the real clincher is this: While Australian surgeons are more than happy to insert mesh into women's pelvic floors, they're not so willing to remove it. In fact, there are only two doctors in the world who offer to take out transvaginal mesh, and both live in the United States.

To have the toxic mesh removed requires a six-month stint off work to visit the US, and an upfront payment of $50,000, something Kim pursued and succeeded with.

There are only two doctors in the world who offer to take out transvaginal mesh. (Image supplied)

While the mesh might be out of her body, the havoc it wreaked is irreversible and will stay with Kim forever.

"My mesh was embedded in my bowel, my rectum, and my urethra," Kim told me. "Now, my whole pelvic floor is just a massive scar tissue. I am now incontinent, my nerve damage and muscle damage is permanent, and I live on medications."

Kim also lives with a level of anxiety she likens to post traumatic stress disorder.

"I'm certainly not the woman and I am not the mother I once was," she said. "I feel like I've lost a big part of myself. I can't be with my kids as much as I'd like, I can't play or do all the things I wanted to do with them. There are some days when I can't get out of bed."

If there is any solace in this tragedy, it's that Kim Blieschke can find comfort in the other Australian women who have also lived this hell. In fact, hundreds have reported serious health complications as a result of transvaginal mesh implants to the TGA, and a medical review predicts there are 4000 more silently suffering in the shadows behind them.

When Kim found someone who had experienced what she had online, she was overwhelmed.

"I just burst into tears because I honestly thought that I was on my own," she said. "I was told that it was all in my head, and to find that there was someone else, and for all these women to come forward was incredible.

"It's something that nobody really wants to talk about because people feel embarrassed, but as far as I'm concerned I want everyone to know about it."

"I want everyone to know about it." (Image supplied)

Kim is now one of the handful of women who are leading the charge to have transvaginal mesh implants banned. Her meeting with Victorian Senator Derryn Hinch last year proved pivotal in pushing discussion forward about what Hinch describes as "one of the greatest medical scandals and abuses of mothers in Australia's history".

It falls in line with the opinion of The Royal Australian and New Zealand College of Obstetricians and Gynaecologists, who state that "very little robust information is available on the efficacy and long term safety" of polypropylene mesh to treat pelvic organ prolapse, warning women of "adverse" effects.

Thanks to women like Kim, and Senator Hinch, there is now a Senate inquiry into the mesh, which has a reporting date of November 30.

But the aim is to do more than just have the mesh banned - it's to get justice.

"We would like someone to be answerable to this," Kim explained. "Because none of the surgeons are mandated to report the complications, they don't. We want women to have informed consent, because a lot of women are just told this is a straight forward operation when it's not, it can ruin lives."

And on behalf of Mamamia, we dearly hope Kim, and the many women beside her, succeed.

If you are a victim of transvaginal implants, Mamamia encourages you to lodge a complaint by clicking on your state: 

Victoria; New South Wales/ACT; Queensland; South Australia; Western Australia; Tasmania; Northern Territory.

 http://www.mamamia.com.au/transvaginal-mesh-implants/

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

Patient Outcomes Research Rejected at Harvard/Mass General 100 Years Ago

Honoring a once-scorned voice for medical openness

DAVID L. RYAN/GLOBE STAFF

Dr. Ernest Amory Codman told his wife before he died in 1940 not to spend money on a headstone. Dr. Andrew Warshaw spent the last two years raising $20,000 from medical organizations for a granite and bronze memorial that will be dedicated Tuesday.

By Liz Kowalczyk GLOBE STAFF  JULY 21, 2014

Dr. Ernest Amory Codman was in his mid-40s when his golden career as a sought-after Harvard surgeon began to unravel. He had quit in exasperation from Massachusetts General Hospital, and when he took his dispute with hospital leaders public, colleagues turned against him. Many stopped sending him patients.

MASSACHUSETTS GENERAL HOSPITAL ARCHIVES

Dr. Ernest Amory Codman.

It was the early 1900s, and Codman was impatiently pushing hospitals and doctors to adopt a practice many considered heretical at the time: Record the “end results’’ for every patient — including harm caused by physicians’ errors — and make them public.

A century later, many of Codman’s ideas are the bedrock of modern medicine. And a group of doctors, including a former Mass. General surgery chief, plans to make sure he gets the wider appreciation he deserves this week.

Codman’s ashes are buried in his wife’s family plot in Mount Auburn Cemetery in Cambridge, with no personal marker. Dr. Andrew Warshaw, the hospital’s chief of surgery from 1997 to 2011, has spent the last two years raising $20,000 from medical organizations for a granite and bronze memorial that will be dedicated Tuesday.

The headstone is “an overdue homage” to Codman and the ideas he pushed at Mass. General and nationally, Warshaw said. “His senior doctors couldn’t be bothered. They said it wasn’t necessary. Of course, people were threatened.’’

Even after Mass. General began tracking some outcomes, making that information public was anathema. “The general executive committee does not consider it advisable,’’ Dr. Joseph Howland, the hospital’s assistant administrator, cryptically wrote Codman in April 1914.

Codman himself lived his beliefs with excruciating honesty.

“I made an error of skill of the most gross character and even failed to recognize that I had made it,’’ he wrote in a published report after a woman died following a gallbladder operation in 1917.

These days, there is little escaping Codman’s notions, as everyone from patient safety groups to President Obama pushes for measurable quality and transparency in medical care.

Codman’s close examination of patient cases led to weekly meetings now held at Mass. General and many other hospitals called “morbidity and mortality’’ conferences, and his insistence on “hospital standards’’ eventually prompted the formation in 1951 of the Joint Commission, a national organization that evaluates hospitals.

“He deserves to be much better recognized,’’ said Dr. William Mallon, a shoulder surgeon who wrote a comprehensive biography of Codman that was published in 1999.

But it was not until another Harvard physician, Dr. Lucian Leape, started publishing studies on the frequency of medical errors in the 1990s that the profession and government began to intently examine the issue.

And it has been only in the past 10 years that regulators, patient safety experts, and some doctors have advocated for making outcomes and errors public, as a way to further encourage improvement. As Mallon pointed out, however, few physicians are as open as Codman about their mistakes, in part because of the threat of lawsuits, and mortality and morbidity conferences remain highly confidential.

Dr. Lamar McGinnis, a cancer surgeon from Georgia who has researched Codman’s career, said it was not only his ideas, but his abrasive personality that hurt him professionally. “He was really stepping on toes,” McGinnis said.

‘He deserves to be much better recognized.’

Frustrated with Mass. General’s refusal to fully embrace his ideas, Codman left his full-time job there in 1911 to start his own 12-bed hospital in a Beacon Hill brownstone. He required his doctors to report their results and he tracked his own patients on hundreds of 3 x 5 cards. He advertised the “Medical Ethics of the Codman Hospital’’ — a mission statement of sorts that stated “large fees are only justifiable’’ when a surgeon’s skills have been proven.

Codman continued to pursue changes at Mass. General, and while the hospital began to track patient outcomes, it stopped short of investigating the reasons for poor results, according to letters Codman wrote to hospital administrators. He warned that his ideas were gaining traction in Philadelphia, threatening Mass. General’s position as a national leader.

“It is really easier to overturn a whole city than it is to wake up the trustees of Massachusetts General Hospital,’’ he said in a letter in March 1914, the month he cut ties completely with the hospital to protest the seniority system. Codman urged Mass. General to “do some house-cleaning’’ and stop promoting doctors because of their reputations instead of advancing those with good results.

Codman’s surgical career took a dive in January 1915, when he organized a meeting on hospital standards as chairman of the Suffolk District Surgical Society. Before dozens of colleagues, Codman unveiled a cartoon he had asked a friend to draw.

An ostrich with its head buried in the sand kicked out golden eggs to Back Bay doctors. The heads of Mass. General watched, scratching their heads and asking, “If we let her know the truth about our patients, do you suppose she would still be willing to lay?’’

The audience was aghast, Codman later wrote. He was told to resign as chairman of the group, and as referrals plummeted that year, so did his income — to $5,000 from $8,000 the prior year. He closed his hospital to help treat the injured after two army munitions ships collided and exploded in Halifax, Nova Scotia, in December 1917.

MASSACHUSETTS GENERAL HOSPITAL ARCHIVES

Dr. Ernest Amory Codman shocked colleagues with a cartoon critical of Back Bay doctors.

Still, Codman was hard to ignore back in Boston. He became an expert in shoulder surgery and bone sarcoma, and Mass. General reinstated him as a consultant in 1929. By the time he died in 1940 at his home in Ponkapoag, now Canton, the wounds appeared healed.

Two weeks after his death, trustees at Mass. General, which had begun to adopt his ideas, passed a resolution calling him a “champion of truth’’ who was “willing to sacrifice personal place and standing to achieve what he believed to be right.’’

Codman never recovered financially after his surgery practice dwindled, according to his biographer, and he told his wife before he died of melanoma in 1940 not to spend money on a headstone.

The memorial project took far longer than Warshaw expected.

Codman and his wife, Katherine Putnam Bowditch, did not have children, and doctors were unable to find a relative to give permission for the headstone. So Warshaw contacted Mount Auburn, which began researching the expansive cemetery plot, purchased by the prominent Bowditch family in 1845. Nathaniel Bowditch, Katherine’s great-grandfather and a ship’s captain from Salem, was a pioneer of modern maritime navigation.

Mount Auburn determined that it controlled a portion of the plot, and gave Warshaw permission to move forward with a memorial. Warshaw, who will become president of the American College of Surgeons in October, plans to make Codman’s accomplishments the theme of his opening speech in San Francisco.

A small private ceremony will be held at his gravesite on Tuesday. The memorial, which describes Codman as the “father of outcomes assessment and quality measurement in health care,’’ sits under a shady stand of eight Canadian hemlocks, just behind Nathaniel Bowditch’s grave.

Inscribed under Codman’s name and portrait in bronze are these words: “It may take a hundred years for my ideas to be accepted.’’

Liz Kowalczyk can be reached at kowalczyk@globe.com

USA Patient Network-Advanced Patient Training Workshop June 3-4, 2016

I (Joleen Chambers) attended this excellent workshop last weekend (photo above).  Every patient should have this information BEFORE taking any drug or being treated with any medical device!  Dr. Diana Zuckerman, President of the National Center for Health Research hosted the workshop and these are her presentation slides.  I also must thank PCORI (Patient Centered Outcomes Research Institute) for awarding partial financial support to the host organization of this workshop.  

PLEASE SHARE!!!!

FDA has a 'hearing problem'. Harmed patients (women) amplify social media voice!

FDA Reviews Essure to See if Device Causes Problems by REUTERS  9/23, 2015

U.S. health experts will review the potential risks of Bayer AG's permanent contraceptive device, Essure, on Thursday in light of growing complaints over possible side effects, and consider whether its use should be restricted. Some 17,000 women who had the device implanted and claim it has hurt them are members of the Facebook group "Essure Problems," run by Angela Lynch, who herself experienced problems with Essure. Complaints voiced by the women include chronic pain, heavy bleeding, fatigue and skin allergies. The Food and Drug Administration panel will be asked to discuss potential changes to the product's label and whether further clinical studies should be conducted. The panel will not be asked to formally vote on their recommendations. Bayer obtained the device with its $1.1 billion acquisition of Conceptus in 2013 and maintains it is safe and effective. It says roughly 750,000 units have been sold, mostly in the United States. It's a small metal spring that goes into the fallopian tubes - an alternative to tying them. Dr. Patricia Carney, the company's medical director for Essure, said the company welcomes the discussion. "We want to understand as a company what is going on," she said. "We want to know whether there is a link to the product." Already the complaints have led some physicians to re-examine their use of the device. Dr. Sebastiaan Veersema, a gynecologist at St. Antonius Hospital Nieuwegein in the Netherlands, was an early European adopter, implanting the device in nearly 1,400 women and training dozens of practitioners in its use. He now believes more research needs to be done to establish what, if any, relationship exists between the device and the problems relayed by some patients. "If there is something wrong with the device I want to know," he said. Veersema said a stronger screening process might be warranted to avoid implanting Essure in women who already have a uterine problem, such as fibroids. Angela Lynch was 28 when she was implanted with the device. She had three children and did not want any more. "Because I had just had a kid I wrote off all my symptoms as hormonal, my body trying to adjust," she said. "After two years I started losing hair. Then I started losing teeth, and over time it got to where my whole body was hurting." In 2012 she had the device removed and underwent a hysterectomy. "After three days it was like I woke up from a five-year flu," she said. Dr. Cindy Basinski, who consults for Bayer and will be testifying on the company's behalf at the FDA meeting, has been implanting the device since 2006 and has conducted about 1,100 procedures with minimal complications. She has had "a couple" of patients come to her with complaints and one asked for the device to be removed. Basinski, who practices in Newburgh, Indiana, said she in "no way discounts the patients out there recounting their experience," but said it was not possible to draw scientific conclusions from anecdotal information. For some doctors, it is not just the implantation of the device that needs to be looked at but how it is removed. Dr. Shawn Tassone, who practices at a clinic in Austin, Texas, began implanting Essure in 2008, said there is no standardized method for removal. "I'm hoping that all this will change the way doctors counsel their patients," Tassone said. "Instead of saying Essure is an easy procedure with no side effects, (they should) say this is a surgery and there are people reporting complications."

http://www.nbcnews.com/health/womens-health/fda-reviews-essure-see-if-device-causes-problems-n432351

FDA, Medical Device Industry Profit and Harmed Women Collide With Pope Francis in DC on September 24

Essure complaints spike nearly 1,400% in 3 years

SEPTEMBER 22, 2015 BY BRAD PERRIELLO 

The FDA logged a nearly 1,400% spike in complaints filed over the Essure permanent female sterilization treatment made by Bayer (ETR:BAYN), according to a review released yesterday ahead of an FDA advisory panel meeting this week.

Essure, the only approved permanent birth control device in the U.S., is a small metal coil that is placed in the fallopian tubes via catheter. The FDA approved the device in November 2002.

In the near 13 years since then, the health regulator said it had received 5,093 complaints, including those of pain or menstrual irregularities after using the device, as well as complaints of the device breaking. Those adverse event reports include 5 fetal deaths in women who became pregnant after using Essure and 4 adult deaths for reasons such as infection and uterine perforation, the FDA said.

There were 152 complaints filed in the FDA’s Manufacturer & User Facility Device Experience database in 2012; last year there were 2,259 complaints filed in the MAUDE database, a 1,386% increase. So far this year there have been 1,363 MAUDE complaints filed with the FDA, the agency said. The FDA cautioned that the complaints it received had limitations such as incomplete or inaccurate data and did not necessarily directly indicate a faulty or defective device.

The FDA’s Obstetrics and Gynecology Devices advisory panel is set to meet Sept. 24 to discuss the risks and benefits of Essure and has invited feedback from presenters, panel members and the public. Some 17,000 women who had the device implanted and claim it has hurt them are members of the Facebook group “Essure Problems,” run by Angela Lynch, who herself experienced problems with Essure. Complaints voiced by the women include chronic pain, heavy bleeding, fatigue and skin allergies.

Lynch, who was 28 when she was implanted with the device, had 3 children and did not want any more.

“Because I had just had a kid I wrote off all my symptoms as hormonal, my body trying to adjust,” she said. “After 2 years I started losing hair. Then I started losing teeth, and over time it got to where my whole body was hurting.”

In 2012 she had the device removed and underwent a hysterectomy.

“After 3 days it was like I woke up from a 5-year flu,” she said.

In May, Bayer cited a 364-patient 5-year study of the device published in the Journal of Minimally Invasive Gynecology that indicated no pregnancies after 5 years and that the Essure inserts were “generally well tolerated.” Pelvic pain was reported in no more than 7% of patients, but no study participants reported persistent pelvic pain of any kind at the 3-, 4-, and 5-year follow-up visits, according to Bayer.

The study reported 3 serious adverse events “possibly related” to Essure in the trial, including irregular menstrual bleeding, lower abdominal pain and heavy periods and continuous bleeding. The latter 2 patients ended up having hysterectomies.

Dr. Patricia Carney, the company’s medical director for Essure, said Bayer welcomes the discussion. “We want to understand as a company what is going on,” she said. “We want to know whether there is a link to the product.”

In February a citizens petition lodged with the FDA asked the safety regulator to take Essure off the U.S. market, alleging that the clinical data the FDA used to approve the device was fudged and that the company concealed adverse events associated with Essure.

In July, the FDA approved using transvaginal ultrasound as an alternate test to confirm if the Essure implant has been placed properly. A month later Bayer cut the ribbon on a new plant in Costa Rica where it plans to make Essure.

Material from Reuters was used in this report.

http://www.massdevice.com/essure-complaints-spike-nearly-1400-in-3-years/

Proto-AE: FDA Monitors Social Media

FDA panel set to vet Essure safety

By: M. ALEXANDER OTTO, Ob.Gyn. News Digital Network SEPTEMBER 22, 2015

On Sept. 24, the Food and Drug Administration’s Obstetrics and Gynecology Devices Panel will meet in Silver Spring, Md., to discuss the future of Bayer’s Essure permanent female sterilization coil.

FDA officials have asked the 19-member advisory panel to evaluate the currently available scientific data on the safety and effectiveness of the Essure system and make recommendations on appropriate use, product labeling, and the potential need for additional postmarket clinical studies.

Since Essure’s approval in 2002, the FDA has received more than 5,000 complaints about Essure. Most concern chronic pain, perforation, dyspareunia, device migration, menstrual problems, and possible allergic reactions to the nickel in Essure, but more than 100 adverse symptoms have been reported to the agency, according to newly posted meeting materials.

The complaints have been filed mostly in the past 2 years by patients who have organized online to share their stories and lobby to have Essure taken off the market; some are involved in legal action against Bayer. Meanwhile, Bayer maintains that, for most of the approximately 750,000 women who have received Essure, the device is safe and effective.

Advisory panel members will have their work cut out for them as they sort through the issues. The FDA has released a new 89-page review of Essure, and Bayer has submitted its own lengthy review document. Testimony is expected from Bayer, FDA reviewers, patients, and others. The meeting is scheduled to run almost 12 hours, from 8 a.m. to 7:30 p.m. Eastern time, at the agency’s White Oak Campus in Silver Spring, Md., and will be broadcast live online.

FDA noted in its review that it has been monitoring social media with automated software that scours Twitter, Facebook, patient forums, and other websites for “posts with resemblance to adverse events” or “Proto-AEs.” The program picked up 350,000 references to Essure between September 2013 and July 2015 and classified more than 20,000 as Proto-AEs, mostly related to pain, hysterectomy, malaise, pregnancy, and device removal. The social media data, however, are preliminary since the FDA has yet to remove duplications and retweets.

aotto@frontlinemedcom.com

http://www.obgynnews.com/index.php?id=11192&tx_ttnews%5Btt_news%5D=436145&cHash=e624afa2524b5dffe9ae6f48474e9351