FDA Violations and Highest Risk FDA Bayer Essure

Original Essure Manufacturer Had Long History Of FDA Violations

By Michael Monheit    March 10th, 2016

In 2013, German pharmaceutical manufacturer Bayer acquired a small California-based company named Conceptus Inc. As the name suggested, Conceptus’ work in medical devices focused on reproduction, but the company made few waves with its first product line, a system of miniature catheters used to access Fallopian tubes.

It was what Conceptus eventually attached to those micro-catheters that would garner Bayer’s interest, and ultimately convince the multinational conglomerate that Conceptus was worth around $1.1 billion.

“Unanimous Approval” & Growing Profits

Conceptus had developed Essure, a metal coil implant that could be guided through the uterus and inserted into a Fallopian tube. After implantation, the body naturally reacts to the device, or more accurately, the polyethylene terephthalate (PET) fibers wound around the device’s nickel titanium coils. In textile manufacturing, PET is referred to by its more familiar name, polyester. But inside the body, according to Conceptus, PET has a different effect: triggering the growth of scar tissue.* Once the Essure implant has been inserted, the Fallopian tube coats the device in a thick layer of scar tissue, the company says, blocking both the tube itself and any eggs traveling to the uterus.

Essure’s innovative design certainly seemed promising, and Conceptus spent the years between 1998 and 2002 developing and testing the device. After “receiv[ing the] FDA’s most stringent review prior to marketing,” the agency’s so-called Pre-Market Approval process, Essure was approved for sale on November 4, 2002.  Essure was, and continues to be, a Class III medical device, among “the highest risk devices,” according to the FDA.

Few people are aware that the FDA uses two very different processes to regulate medical devices and pharmaceutical drugs. More often than not, medical devices are sent through a fast-track approval process, in which manufacturers need only show that their own device is substantially similar to one already on the market. In practice, though, that “substantial” similarity appears to be loosely interpreted. Many devices make it on the market, and thus into operating rooms and patients’ bodies, without any new safety or effectiveness testing.

But Essure was different, with a radically novel design, one the FDA guessed could cause patient’s significant harm. So the agency required clinical trials involving human subjects. By the time Essure was approved, in 2002, “the FDA had one to two years of safety and effectiveness outcomes data for Essure,” according to Jennifer Rodriguez, an FDA spokesperson who spoke to ABC News in October 2014. A “unanimous approval” followed, with the caveat that Conceptus would continue studying the device’s safety in several required studies.

Essure Soon Marred By Manufacturing & Side Effect Reporting Problems

In the meantime, obstetricians and gynecologists were beginning to adopt Essure as an alternative to tubal ligation, the industry standard for permanent female sterilization. Essure was easier, requiring only a 10-minute outpatient procedure to implant, Conceptus claimed. Citing the results of its clinical trials, which have now been widely critiqued, the coils were “safe and effective.”

Essure was on the ascendant, and Conceptus representatives were busy training doctors around the nation on how best to use the implants. By the end of 2003, according to a company shareholder report available here, “more than 14,000 patients” had been implanted with Essure, and no “pregnancies related to device failure” had been reported. Even more encouraging, Conceptus was turning a profit, reporting $442,000 in gross profits for the 4th quarter of 2003.

But for all the early signs of success, and Conceptus’ growing national reach, problems were beginning to crop up back at home, in Mountain View, California.

Spotty Record-Keeping & Rejected Raw Materials

During a series of routine inspections in June and July of 2003, FDA investigator Mark Chan noticed a discrepancy between Conceptus’ Lot History Records and the information included on Quality Assurance Forms, which track to show that a device is being made in the way its manufacturer said it would be.

Specifically, Chan found “hand-written” notes on the company’s records, which revealed that “raw materials and sub-assemblies (i.e., Inner/Outer Coil Sub-assemblies) were being rejected during” the manufacturing process. But that information wasn’t making its way onto the company’s Quality Assurance Forms, which would have notified Conceptus’ Quality Assurance department of the problem.

In a formal report, known as a Form 483, issued by the FDA when inspectors think they’ve discovered violations of federal law, Chan observed: “not all data […] are analyzed to identify existing and potential causes of nonconforming product and other quality problems.” The inspector also discovered that no “Material Review Reports,” which would have notified an entirely different board within Conceptus of the problem, were being generated either.

Why the materials were rejected in the first place is uncertain, but in Chan’s mind, Conceptus wasn’t checking up on potentially-defective raw materials, and it seemed to be a problem of communication between the company’s departments. In a recent lawsuit, one former Essure patient raised an even more troubling question: where did the rejected raw materials end up? In a trash bin or in an implant?

Conceptus Used Unlicensed Facility For 3 Years, California Health Department Finds

Whatever the answer, observers could not deny the severity of Conceptus’ next run-in with regulatory officials, this time inspectors at the California Department of Health. In 2008, the company was cited for manufacturing Essure implants out of an unlicensed facility.

Conceptus had been using the facility, state Health Department investigators said, for three years. By June 11, 2008, according to a narrative report completed by Health Department Investigator Christine Rodriguez, Conceptus’ licensing violations had been “corrected.” Finally, Conceptus was licensed to manufacture medical devices in California, but the company was far from out of the woods.

FDA Inspector Discovers Unreported Adverse Events

Between December 2010 and January 2011, FDA investigator Timothy Grome reviewed company documents and found evidence that Conceptus had failed to report multiple adverse events to the FDA.

Grome discovered two reports, sent to Conceptus by health professionals between July 12, 2010 and December 10, 2010, of women in whom the Essure implants had perforated their bowels, a complication that could “have caused or contributed to a death or serious injury.” But rather than pass these reports on to the FDA, as the company had with 41 other reports that did not involve bowel perforation during the same period, Conceptus appeared to have kept them internal.

A different report, in which a CT scan had revealed that a patient’s implant “was in 2 pieces […] with one of the pieces outside of the tube between the uterus and bowel,” had also been kept from the FDA, Gromes wrote in a Form 483 that would follow his inspection.

Conceptus’ apparent reporting violations between December 8, 2010 and January 6, 2011 were even more egregious. Gomes found no less than five reports of “perforation,” in which the coil implant had moved into a patient’s abdominal cavity or peritoneal cavity. But none had been submitted to the FDA as required, within 30 days of their receipt.

Gomes hit Conceptus with a related violation, since the coil’s obvious ability to move into the peritoneal cavity had never been included in the company’s official analysis of potential device failures.

Conceptus Denies Device Failure

After Gomes’ visit, the California Department of Health returned to Conceptus’ manufacturing facility for a routine inspection required by state law. While no new violations would be issued at this time, the Health Department’s subsequent report sheds light on the company’s response to the FDA’s findings.

In a letter sent to the federal agency on January 20, 2011, state health investigator Lana Widman wrote, Conceptus “disput[ed] the validity of [Gomes’] observations, regarding the reporting of complaints for peritoneal perforation.” According to Conceptus, the perforations were “a result of the physician’s misuse of the device or an error during insertion and not a failure of the device to perform as intended.”

Today, the FDA is busy drafting a new “black box” warning for Essure. While the final wording of this warning has not yet been published, it is likely to include “fallopian tube or uterine perforation,” alongside side effects like “persistent pain, irregular vaginal bleeding,” and the complication Conceptus failed to report nearly 6 years, “intra-peritoneal device migration.”

*This account of Essure’s mechanism of action has been called into question. In fact, according to several women who have filed Essure lawsuits, Conceptus’ own account of how the device works has changed. During a pre-approval meeting, plaintiffs claim, the company told FDA officials that “the trauma caused by [an] expanding coil striking the Fallopian tubes is what cause[s] the inflammatory response of the tissue,” not the PET fibers themselves.

http://birthcontrolproblems.com/conceptus-fda-violations/

FDA and Bayer Essure Asked to Explain: 303 Fetal Deaths and Kickbacks

FITZPATRICK QUESTIONS FDA OVER ESSURE DATA, ALLEGED KICKBACKS

Jeffrey Shuren, M.D., J.D.

Director, Center for Devices and Radiological Health

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993

February 16, 2016

Dear Dr. Shuren,

As you are aware, thousands of women have filed formal complaints to the Food and Drug Administration regarding the permanent contraceptive device Essure. These injured women have reported numerous symptoms related to this FDA-approved device, such as extreme pelvic pain, allergic and immunological reactions, heavy bleeding, unexplained weight gain, loss of teeth and hair, and broken coils migrating throughout their body and puncturing internal organs.

Tragically, this device has also killed innocent women and unborn children. The FDA’s public materials related to Essure have cited five reports of fetal deaths.

However, my office is in receipt of a review of adverse event reports related to Essure, conducted by women harmed by this device and an adverse event data expert. This independent report counts 303 fetal deaths. A copy of this report is enclosed.

In light of this immense discrepancy, I request that the FDA conduct a thorough review of this document and all of the adverse event reports received by those harmed by Essure as part of FDA’s on-going review of this medical device.

Additionally, my office is in receipt of an unsealed complaint filed in the U.S. District Court for the Northern District of California which named the United States of America, 27 States, and the District of Columbia as plaintiffs against Conceptus, Inc., Bayer AG, Inc. and Bayer Healthcare, LLC. A copy of the complaint is enclosed.

The complaint alleges that the manufacturer of Essure gave substantial and illegal financial inducements to providers to encourage them to use Essure, a procedure that costs the government almost $3,500 per patient.

According to the complaint, the manufacturer of Essure provided illegal kickbacks in the form of free medical equipment valued at $20,000. Additionally, the complaint alleges that the manufacturer of Essure would set up “referral lunches” to generate business by connecting primary care physicians and Ob/Gyns to create what the manufacturer called “coin-operated doctors,” designed to lead to the increased use of Essure. Furthermore, the manufacturer provided free marketing and advertising services to Ob/Gyns to encourage them to use Essure on their patients.

These alleged illegal kickbacks cost the taxpayers millions of dollars due to false claims against government healthcare programs such as Medicare, Medicaid and Tricare.

In addition to the review of 303 fetal death reports, I request that the allegations of illegal kickbacks filed against the Essure manufacturer also be included as part of the review being conducted by the FDA.

Sincerely,

Mike Fitzpatrick

Member of Congress

http://www.modernhealthcare.com/article/20160217/NEWS/160219918/congressman-says-fda-grossly-underestimated-harm-of-permanent#comments

http://bit.ly/1PRfMor

Congressman says FDA grossly underestimated harm of permanent contraceptive Essure

By Shannon Muchmore  | February 17, 2016

A U.S. congressman and a patient advocacy group said Wednesday a permanent contraception device linked to thousands of adverse events has led to far more fetal deaths than previously reported and that doctors performing the procedure received illegal kickbacks.

Rep. Mike Fitzpatrick (R-Pa.) said in a conference call with reporters that he found it troubling that the U.S. Food and Drug Administration did not act on the complaints it had received until thousands of women who said they had been harmed by the device started publicly announcing their concerns.

“They came together as a group frankly because nobody would believe them, not even their own doctors,” he said.

Madris Tomes, a medical-device reporting expert with Device Events, said she searched publicly available FDA data to find 303 reports of fetal deaths, a stark contrast to the five previously reported by the FDA, the agency responsible for evaluating the device's safety and usefulness.

The FDA was not immediately available for comment.

Fitzpatrick also discussed a complaint filed in the U.S. District Court for the Northern District of California that alleges doctors received $20,000 of free medical equipment for agreeing to buy 25 Essure kits.

The complaint also states that manufacturer sales representatives would organize lunches with primary-care providers and OB-GYNs, to generate more referrals to the OB-GYNs who produced the most revenue and advertised the most. The sales team internally referred to such providers as “coin-operated doctors.”

Fitzpatrick said he is coming forward with the information before the FDA is expected to release new guidance on the use of Essure later this month so that the agency can take it into account.

Essure can be installed by a doctor at a regular office visit lasting less than an hour. A small, flexible coil is inserted into each fallopian tube, causing scar tissue to form and block eggs from getting into the uterus.

The FDA approved the procedure in 2002 and Bayer bought the device from Conceptus in 2013. Some women who had the device implanted, however, said they suffered from intense pain and heavy bleeding. Complaints also included fetal deaths and uterine perforation.

The FDA issued an alert in June after a search of its Manufacturer and Use Facility Device Experience Database found more than 5,000 adverse-event reports. 

In September, the FDA Obstetrics and Gynecology Devices panel said use of Essure should be limited because not enough research has been performed to prove it is safe. The panel took no formal vote, however, and did not take the product off the market as many advocates had requested.

Fitzpatrick, who has introduced a bill requiring the FDA to pull its approval of Essure, sent a letter this week to the director of the FDA Center for Devices and Radiological Health, outlining the findings and requesting an immediate review.

FDA Approved Medical Device Being Blamed For Countless Injuries, Medical Conditions

February 17, 2016 1:51 PM By Mike Dougherty

http://philadelphia.cbslocal.com/2016/02/17/thousands-push-for-medical-device-linked-to-fetal-deaths-taken-off-market/#comments

PHILADELPHIA (CBS) — Congressman Mike Fitzpatrick is calling for the Food and Drug Administration to ban the use of a medical device that’s been the source of tens of thousands of complaints.

Bayer Essure is implanted into the fallopian tubes for permanent sterilization, but women are reporting widespread complications and even death.

Essure has an FDA gold stamp of approval, but Congressman Fitzpatrick says it’s responsible for more than 300 fetal deaths and countless other medical complications.

It goes deeper. Fitzpatrick says kickbacks from Bayer, the manufacturer provided illegal financial incentive to doctors.

“The manufacturer is providing free marketing and advertising services to OB/Gyn. They were encouraging them to use Essure on their patients, and they were making a lot of money.”

Fitzpatrick says money from insurance companies, tax payers and women like Amanda Dikeman, who went through years of pain and suffering before the device was removed.

“My once very thick hair began falling out in clumps. I battled continuous urinary tract and kidney infections.”

Lawmakers want to know why it took so long for the FDA to receive patient complaints and why nothing has been done about them.

http://philadelphia.cbslocal.com/2016/02/17/thousands-push-for-medical-device-linked-to-fetal-deaths-taken-off-market/#comments

Women Want Bayer Essure Taken Off Market

Essure is a medical device that gets surgically inserted into a woman's fallopian tubes. It's marketed as a form of permanent sterilization for women, but it's been linked to more than 300 fetal deaths, and a group of 27,000 women on Facebook want to see it taken off the market. KYW's Mike Dougherty reports.

Mike Dougherty  Mike is a general assignment reporter and editor for KYW Newsradio 1060. His career at 1060 began as a desk assistant in January '07. A short nine months later, he was promoted to AM Drive writer while still studying broadcast journalism at Temple...

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

  0   0   0   209

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 'birth control' Harm is in the news! Sign Change.org petition, please

Please sign this petition:  https://www.change.org/p/u-s-house-of-representatives-amend-the-biomaterials-access-assurance-act-of-98?utm_campaign=responsive_friend_inviter_chat&utm_medium=facebook&utm_source=share_petition&recruiter=237367236

Metal coils and furious women: The stunning controversy behind an FDA-approved birth control

By Mary Rezac  (FiDA highlight)

Denver, Colo., Feb 20, 2015 / 04:02 am (CNA/EWTN News).- Perforated organs, metal coils lodged in colons, fetal disfigurement due to nickel poisoning. Chronic pain, exhaustion, bouts of depression and suicidal thoughts.

It’s the stuff nightmares are made of. But these are real symptoms that are being blamed on a real medical device, one that is being protected by the FDA. The device, Essure, is a permanent type of birth control in the form of tiny metal coils inserted into women’s fallopian tubes.

But while it’s been on the market since 2002 and has been touted as safe and effective, thousands of people are starting to come forward and question the device, including doctors very familiar with it.

It started out as a standard procedure for Dr. Shawn Tassone, Ob/Gyn. He was inserting Essure coils into a patient. The 10 minute, in-office procedure was supposed to be quick, simple and painless, and it was one he had performed many times before.

“I remember…I put the Essure in, exactly like how you were supposed to, and then as I sat there the tube started to spasm, and it pulled the Essure in,” he told CNA. “It disappeared, it coiled right into the tube.”  

Unsure of how to proceed, he looked at the product manufacturer’s representative, who was in the room with him. The representative told him to just put another coil in the same tube, but Dr. Tassone knew that was against the product’s instructions.  

“I told (the representative) that, and he was like, 'Nah, that’s not necessarily true',” Dr. Tassone said. “And you’re just being told this stuff by these reps who are college graduates, and I’m sure their hearts are in the right place, but they also want you to do the procedure because they get reimbursed more.”

It was through personal experiences with patients, as well as hearing other women’s stories, that Dr. Tassone eventually stopped doing a procedure he’d once been so sure was safe and effective. He said that while he’s not a conspiracy theorist, he does believe there are a large number of women with severe complications from Essure that are not being acknowledged by the medical community at large.

A Facebook group 14,000 strong

A lot of these women can be found on the Facebook group, Essure Problems. Of the 14,000-plus members, the majority are women who share a strange kind of sisterly bond – almost all of them have had Essure, and almost all of them bitterly regret it.  

When the Essure coils are implanted, they are supposed to stay in the fallopian tubes, where they create a chronic infection that will cause scar tissue to form around the coils, effectively closing the tubes and rendering the woman sterile. The device was first manufactured by the group Conceptus and pre-approved by the FDA before hitting the markets in 2002. In June 2014, Conceptus was bought by Bayer, which has continued to manufacture and distribute Essure.

Some possible side effects after the Essure insertion procedure are listed on the product’s website and include: “mild to moderate pain and/or cramping, vaginal bleeding, and pelvic or back discomfort for a few days. Some women experienced nausea and/or vomiting or fainting. In rare instances, an Essure insert may be expelled from the body.”

Angela Desa-Lynch, an administrator for the Essure Problems group, said the women in the group have experienced these problems to the extreme.

“Whatever they’ve put on the label, multiply it by 200,” she said. “They say chronic pain, or they say mild cramping or abdomen pain, but they don’t tell you that it’s debilitating. They don’t tell you that it’s 'I can’t get out of bed and take care of my kids' kind of pain.”

When Desa-Lynch had her Essure coils in, she said she felt like she had the flu constantly. She was 28 years old, and her youngest son was just three months old.

“My little son…he had no idea the real parent I could be, because I was going through all these health problems,” she said. Desa-Lynch had to have a total hysterectomy to remove the coils, but she said the recovery process didn’t end with the removal.  

“You’re mad,” she said. “This is not what I signed up for. I just wanted a birth control, I didn’t want a life time of health issues, and to remove my woman parts, that’s not ok.”

Watching the posts on the page can be an emotional rollercoaster, Desa-Lynch said. She hears from women who’ve become depressed, suicidal, divorced, bankrupt, or a combination of those things after having complications from Essure.

Moving coils and the difficulty of removal

One of the most horrific complications is device migration, where the coil leaves the tube and becomes lodged in other parts of the body, usually the colon or somewhere in the pelvis. This can cause a blocked colon or other complications.

It can be extremely difficult for women who want to have their Essure coils removed. Many doctors will deny that the Essure is the root of women’s problems, because the clinical trials they’ve seen from the FDA claim the risks of such complications are so low.

Additionally, Medicare and most insurance companies classify Essure removal as “cosmetic,” which further disincentivizes doctors to remove the coils and often puts women who require the removal into personal debt.

“One woman had a coil in her colon, she went from a business owner to bankruptcy” after four surgeries to remove it, Desa-Lynch said.

Physical removal of the coils can also be difficult because they are fragile and may break.

“You have fragments now in your body, and we’ve had women where they come back after removal and they have these masses growing in their abdomen,” Desa-Lynch said. “Your body’s going to try to encapsulate whatever foreign object is there, and now you have all these little cysts growing everywhere.”

Both she and Dr. Tassone said that from what they’ve seen, the only completely safe and secure way to make sure all of Essure is removed is a total hysterectomy.

What happens if you get pregnant with Essure?

Then there are the women who become pregnant while using Essure. No sterilization method is guaranteed to work 100 percent of the time, save for a total hysterectomy with removal of the fallopian tubes. According to Essure’s website, the device is 99 percent effective at preventing pregnancy, but that is with so-called perfect use.

In the real world, doctors may misplace coils or a woman’s tubes can heal or push Essure out. Furthermore, women given Essure are told to use an alternative form of contraception for the first three months following the procedure until a second appointment which checks for proper coil placement – but many women fail to follow through on this step.

Given these margins for error, a recent Yale School of Medicine study estimated 96 of every 1,000 women who undergo hysteroscopic sterilization, or Essure, would get pregnant within 10 years. For laparoscopic tubal ligations (known as 'having your tubes tied'), the pregnancy risks were significantly lower: 24 to 30 pregnancies per 1,000 women.

In an e-mail interview, FDA representative Eric Pahon told CNA that clinical trials of women who became pregnant with Essure showed “no increased risk of neonatal or pregnancy complications, as long as the pregnancy is in the uterus. The FDA will continue to monitor the safety of Essure to make certain.”

What the women of Essure Problems have found is that doctors will not remove the coils even if a woman becomes pregnant. Most will automatically recommend abortion, because they don’t know what to do.

“They don’t know what can happen, because there is nickel in Essure and it can leach, and the device can move and perforate the sack and has done it, so because the doctors don’t know how to treat you, that’s the first thing they ask you to do is to terminate,” Desa-Lynch said.

Should a woman with Essure choose to continue the pregnancy – and many of them do – she risks nickel poisoning and device migration to her baby, and a 55 percent chance of miscarriage, according to the numbers from the Facebook group.

“Your baby isn’t growing”

One Essure pregnancy story stood out to Desa-Lynch as particularly jarring. A young woman in the Facebook group, born and raised as a devout Catholic, became pregnant despite being on Essure. At 24 weeks of pregnancy, the doctors told her: “Your baby is not growing.”

Her baby had gotten nickel poisoning, so the brain wasn’t developing and the limbs weren’t growing properly. The young woman was told her baby at best would be severely deformed at birth, if not completely brain dead.

“When you’re Catholic, abortion is not something that crosses your mind, you just think 'ok, well, we’ll deal with this',” Desa-Lynch said.

However, after the grim diagnosis, the young woman chose abortion. Desa-Lynch said the woman doesn’t even comment on the Facebook page because she is so haunted by her experience, but she’s there, and she watches the comments.

“I can’t imagine being in her position,” Desa-Lynch said. “It puts you in a hard spot. Here you think you’re doing what’s right for you, what’s right for your family, and what’s right for your health, and now you’re facing these situations that you don’t even know how to handle and neither does your doctor, and you have to go against all of your morals and values…I don’t know what I would do.”

“It goes against a lot of women’s morals,” she added, “and women get severely depressed. Someone posted just yesterday that one of her good friend’s daughters had (Essure) put in and she killed herself, because they go to a doctor and they don’t listen to you.”

When the suicidal posts started popping up more frequently, the group administrators decided to set up a buddy system of sorts. They connected women in the group with other women who were close by, so that they’d always have someone they could go to who understood their situation. The administrators watch posts closely and alert the smaller state groups of concerning posts.

“We work collectively and united,” Desa-Lynch said. “It’s amazing to see women pull together the way that they have and fight for each other.”

False data and bad numbers

As a medical device, Essure had a questionable start at best. When it was pre-approved by the FDA in 2002, the FDA used clinical trials from the device manufacturer, the company which would profit from the approval and sales of the device, to determine whether or not it was safe for women.

When asked if this process created a conflict of interest, the FDA responded: “Although the manufacturer may submit any form of evidence to the FDA in an attempt to substantiate the safety and effectiveness of a device, the FDA relies upon only valid scientific evidence to determine whether there is reasonable assurance that the device is safe and effective.”

Desa-Lynch and the administrators of Essure Problems have three full sets of records from the clinical trials that show complaints of abdomen pain in women in the trial being marked off as “unrelated.”

Dr. Tassone has seen the clinical trials, and said there are times when the ages of women with complaints or complications are crossed off and altered in order to better fit the picture the manufacturer wanted to portray.

“The clinical trials that they were basing their information on were falsified, and we’ve brought this to the FDA,” Desa-Lynch said. “They (the FDA) just say, 'upon their investigation they find everything to be safe, they find the benefits to outweigh the risks'.”

In addition, it is basically impossible to track exactly what percentage of women with Essure have experienced severe complications. Although Bayer and the FDA know that 750,000 kits have been sold, there’s no one keeping track of how many women have had the procedure.

Further complicating the numbers is the fact that multiple kits can be used for a single procedure. Dr. Tassone said he’s used up to three kits on a single woman, which happens if coils break before or during insertion.  

“We have over 200 women who’ve had two kits used on them,” said Desa-Lynch of the Essure Problems group, “So it’s kind of hard to give a percentage on bad numbers.”

Protected status and incentives

But despite the thousands of complaints, Essure is classified as a Class III medical device, a category reserved for devices with PMA (premarket approval). These devices are pre-empted, which means people injured by the product cannot collect damages from the manufacturer.

Typically, Class III medical devices are live-saving devices such as heart stints. The idea behind preemption is that by protecting companies from having to pay damages, it encourages them to continue creating better devices that are necessary for saving and sustaining lives.

The only Class III, protected medical devices that do not save or sustain life? Essure coils and breast implants.

“This is part of the problem,” Dr. Tassone explained. “When you are having studies being done by companies who are falling apart (Conceptus was bought out by Bayer), you have an inherent bias. If the (product) is revoked, then this multi-million dollar project was flawed somehow and they lose money.”

“And you see that with other devices, there is a lot of money involved, and the FDA is not doing due diligence, because sometimes the FDA has people on it who are not necessarily getting paid, but who are affiliated with some of the big companies.”

Doctors, too, receive incentives for using Essure. If they meet a certain implantation quota, the manufacturer gives them a $20,000 scope that can be used to perform multiple procedures. Doctors also are often paid to attend Essure trainings and conferences.

But Dr. Tassone said he believes that most doctors originally implanted Essure because they were told, and truly believed, it was a safe and effective procedure.

“We were told in the beginning that it doesn’t cause any pain and the initial studies that came out said that,” he said. “It makes it look like the doctors are getting greedy by putting Essure in because we get more money, but in reality, 99 percent of us actually believed it was a good procedure and was safer for the patients and it worked.”

He said the procedure itself is still considered less risky than a tubal ligation, which is an involved surgery rather than an in-office procedure. Still, Dr. Tassone stopped implanting Essure about a year and a half ago, and he said it usually doesn’t take much to convince his patients to opt for a different procedure.

“The way I counsel my patients now, I send them to what the Facebook group says,” he explained. “Usually I tell them Essure is a foreign body and it’s permanent - most women don’t want that, when you explain it that way.”  

Lawsuits and Erin Brockovich

There are only a few pending lawsuits involving Essure at the moment, Desa-Lynch said, because the PMA act goes all the way up to Congress.

But the Essure Problems Facebook group intends to fight until Essure is off the market and the PMA act is changed. And they just might win, because of a certain famous lawyer that has joined their fight.

“It kind of started as a joke on the form, like, 'Let’s e-mail Erin Brockovich, haha',” Desa-Lynch said. But they did, “and she listened!”

The lawyer, made famous from a 2000 film about her life as a single mother and environmental lawyer, has created a website, http://www.essureprocedure.net/, where women who’ve had Essure can share their stories and where she posts the latest news about the fight against the device.

“That right there kicked off the empowerment, that kicked off the movement of 'Ok, we can do this',” Desa-Lynch said.

Dr. Tassone said he’d like to see more acknowledgement from the medical community of the pain and suffering Essure is causing some women, as well as more transparency from the manufacturers.

“Acknowledgement is the first step,” he said. “Like the company saying, 'Yeah, this is a foreign body and okay, let’s take a look at this.' That would go a million miles for some of these people, that maybe, it’s not all just in their head.”

He also wonders whether a device that caused similar reactions in men would even be on the market.

“If you have a coil and you said you were going to use it in men for vasectomies and you were going to insert it in to block the testicle from having sperm come out, would we be doing that or not? Because they could feel that implant,” he said.

“But with tubes, and in women’s health – because everything is on the inside - I think it’s out of sight, out of mind.”

Until the Essure Problems group can get their case pushed through in court, Desa-Lynch said it’s enough for them to keep informing women and to prevent them from getting Essure.

“We’ve saved over 600!” Desa-Lynch said proudly. “We keep track of them. That right there is enough to know that this is the right thing to do.”

 http://www.catholicnewsagency.com/news/metal-coils-and-furious-women-the-stunning-controversy-behind-an-fda-approved-birth-control-95749/

Again:  the petition to sign is here  https://www.change.org/p/u-s-house-of-representatives-amend-the-biomaterials-access-assurance-act-of-98?utm_campaign=responsive_friend_inviter_chat&utm_medium=facebook&utm_source=share_petition&recruiter=237367236

Tags: Contraception, Women, Women's Health, Essure, Sterilization