German drugs and pesticides manufacturer Bayer AG will discontinue marketing its birth-control sterilization device Essure in all countries outside of the United States, the company quietly announced this month.

Complaints from women about health problems from the device now number more than 34,000 on one website alone, and lawsuits allege side effects from pregnancies and miscarriages to fatalities, but the pharmaceutical giant maintains its retraction of the “nonsurgical” permanent sterilization implants has nothing to do with its safety profile.

“We would like to reassure the Essure patients and their accompanying health care professionals that this decision is made for commercial reasons and that it is not related to a safety or product quality issue,” the company said in a press release on its French website.

Earlier this year, the Brazilian health authority temporarily banned the device, which is described as the only nonsurgical sterilization procedure for women, and then reportedly reinstated it for use in June after Bayer objected. The same month, however, the company was backpedaling Essure out of markets, including Canada, the United Kingdom and Finland, while denying the withdrawals had anything to do with the device’s safety profile and claiming instead that it was only because of “change in patient demand.”

The latest statement from the company says it has also halted marketing measures in France, Iceland, Lichtenstein and Norway.

 

‘Black Box’ Warning

Last year, the Food and Drug Administration attached a “Black Box” warning — its highest-risk label — to the permanent contraceptive implant saying that it was linked to “poking through the fallopian tubes or uterus,” “persistent pain,” menstrual changes, symptoms “resembling” allergic reactions and autoimmune diseases, and complications requiring surgical removal of the device.

The label came after allegations that the agency itself was hiding and distorting data about fetal deaths due to the implant to protect the pharmaceutical industry rather than the women who would receive it.

Currently, the agency website says it “continues to believe that the benefits of the device outweigh its risks and that Essure’s updated labeling helps to assure that women are appropriately informed of the risks.”

 

Inflamed Fallopian Tubes

Essure is comprised of small nickel and titanium alloy coils that resemble springs found in retractable ballpoint pens, wrapped around a stainless steel and polyethylene terephthalate core, with trailing shards of metal at either end. A physician implants the coils by twisting one into the tissue of each fallopian tube, where, by design, the metals provoke acute and then chronic scarring inflammation called fibrosis that anchors them in place. The buildup of scar tissue can block the fallopian tubes, preventing the egg and sperm from meeting, and mimics some infertility diseases such as endometriosis.

Corporate abortion and sterilization providers, including Planned Parenthood, have had the FDA green light to offer the device since 2002, and they continue to sell it as a “gentle procedure” that “works with your body to create a natural barrier against pregnancy.”

But tens of thousands of women have described the physical ordeals that have followed getting the implant and complained that they weren’t told the real risks. The FDA notes that complaints about Essure include four deaths of women, including one woman who died of an air embolism after her uterus was perforated while having the Essure device inserted and a woman who died of a massive necrotizing infection of her cervix, fallopian tubes and uterus.

The FDA has also reported two deaths of infants born with defects from the implant; 1,113 pregnancies, of which 253 resulted in live births; 386 had unreported outcomes and 474 pregnancy losses, including 138 ectopic pregnancies; and 75 abortions.

Other complaints include:

• 10,746 reports of abdominal pain
• 5,377 reports of heavy and irregular bleeding
• 4,396 reports of headaches
• 3,560 women reporting chronic fatigue
•  3, 270 reporting weight changes
• 2,402 reports of allergy to the metal nickel in the device
• 1,482 instances of the device migrating
• 663 descriptions of the device malfunctioning
• 617 reports of device breakage

 

‘I Am Not Crazy’

Kristin Tyree says her doctor “made it sound like it was the best device ever. No side effects; no nothing,” that she would have them implanted in an outpatient setting in under a half-hour and she’d be back on her feet at work in 24 hours.

The day she had the procedure in 2011, however, Tyree left the hospital in pain, thinking it was “normal” and she would just have to wait it out. “The pain never stopped. I had pain every single day, and I knew there was something wrong. So I called my doctor’s office, multiple times. I set up appointments, multiple times. Every time I was told Essure cannot cause any of this to happen,” she recounted in a YouTube video.

The doctors refused Tyree’s repeated requests to have the device removed until a few years later, when she learned of a Facebook page called “Essure Problems,” where thousands of women were discussing myriad symptoms they associated with the implant.

Scrolling through their stories that described symptoms — ranging from intense chronic pelvic pain and bloating, skin rashes and migraines to autoimmune diseases, including arthritis and lupus erythematosus, as well as pregnancies, multiple miscarriages and even death — Tyree thought, “I am not crazy. This is not just me. I am not alone.”

Tyree became one of hundreds of women who had their fallopian tubes removed along with the coils. Later, to rid herself of unwanted shards and scarring, she underwent a total hysterectomy, at age 26.

A 2017 study found that while many women improve after a hysterectomy, “patients should be counseled that some symptoms may persist or even worsen following surgery.”

 

Pre-Market Approval

In 2002, the FDA fast-tracked Essure because it was “novel contraceptive” and granted it “Premarket Approval,”  a “golden ticket” for pharmaceutical companies since it provides almost blanket protection against lawsuits by users.

Transcripts and video of the review process suggest major gaps in the agency’s investigation of the safety of the device. Concerns raised about a reported 12% failure rate in clinical trials conducted using experts in hysteroscopy and concerns about how that would translate in the hands of 35,000 practitioners with little implanting experience were never addressed.

On top of these criticisms, women from the early clinical trials of the device came forward claiming that data the FDA based its decisions on was replete with fraud — and that study participants’ answers to questions rating the device were changed in trial data without consent.

 

Bayer ‘Stands by’ Its Product

Sympathy for affected women and mistrust of large pharmaceutical companies has grown with public attention to Essure in recent years, fueled by social media and in part by the support of environmental activist and watchdog Erin Brokovich.

Bolstered by support from the FDA and doctors’ groups like the U.K.’s Royal College of Obstetricians and Gynecologists, the company isn’t owning up to a problem yet. “Bayer stands behind the positive benefit-risk profile of Essure, the safety and efficacy of which is supported by clinical trials, more than a decade of science and real-world clinical experience,” Bayer spokesman Courtney Mallon said in a statement response to the Register.

Asked how many complaints the company had fielded about the device, Mallon said, “To date, 23 cases in the Essure litigation in the U.S. have been dismissed in their entirety or significantly narrowed.”

Pressed to say how many more complaints existed, she remarked, “The company does not comment on the number of cases, nor does it believe the number of cases indicates the merit of the claims, or should be used to imply anything as cases come and go.”

 

Doctors Benefit

Lester Ruppersberger, a retired obstetrician-gynecologist and past president of the Catholic Medical Association, fails to see how so-called reproductive health advocates can claim an inflammatory scarring condition is a good thing for women. “Any sterilization or contraception is mutilation of a perfectly normal functioning body gift — fertility,” he said.

“Bayer is getting rich, and doctors get paid more for this than standard sterilization because it saves hospitalization and anesthesia costs, as it is done in the office with mild sedation and moderate pain,” he said.

Doctors net more than $1,100 per device they insert, according to The Washington Post, which is double the $510 paid by private insurance for surgical sterilization in a hospital.

Export Concerns

Others are worried about what will happen to Bayer’s unused stock if and when it is removed from the American market, as well. Bayer is a key partner with the Bill and Melinda Gates Foundation, which is endeavoring to extend birth control to 120 million additional women by 2020.

“We have to make sure that Bayer doesn’t try and dump its remaining stock on women in the developing world,” said Steven Mosher, president of the Population Research Institute. “This has pretty much been the standard practice in the past.”

“If Essure is marketed through aid agencies to women in the developing world,” he added, “it will surely cause considerably more deaths and injuries there than it has in the developed world.”

Celeste McGovern writes from Scotland.