Bayer will discontinue the sale of its implantable birth control product Essure in the US, citing a decline in sales rather than safety concerns over the product, which is the subject of at least 16,000 lawsuits.
Reuters Health reports that the decision follows an announcement by the company in September 2017 to discontinue the sale of the contentious sterilisation device in all countries outside the US.
Bayer said the decision was not related to safety concerns. “The benefit-risk profile of Essure has not changed, and we continue to stand behind the product’s safety and efficacy, which are demonstrated by an extensive body of research,” the company said.
The company said it has informed the US Food and Drug Administration of the decision and will also directly update healthcare providers.
The report says Essure will gradually be phased out and US sales halted by the end of 2018. Doctors will be able to perform Essure procedures throughout 2019, until they are asked to return unused devices by the end of next year.
As of January, Leverkusen, Germany-based Bayer is facing some 16,000 US lawsuits over Essure. The company said it was expecting additional lawsuits.
Plaintiffs allege that Essure, which is implanted in a woman’s fallopian tubes to permanently block an egg’s passage to the uterus, could pierce the tubes. The women claim that metal parts of the device can become loose and migrate into other body parts, causing pain, injuries and severe bleeding. They also claim that the device failed to prevent unwanted pregnancies and led to nickel allergies and depression. The report says the women who sued Bayer allege the German drug-maker knew of the risks associated with Essure, but failed to warn sellers, doctors and regulators of the dangers.
Steven Immergut, a Bayer spokesperson, said the company had sold roughly 1m Essure devices worldwide since the product came on the market in 2002. The majority of those sales were in the US. Since then, the company has seen an average 40% annual decline in US sales, Immergut said.
The report says the FDA was not immediately available for comment but the agency is monitoring Essure in several clinical studies to gather more information on the device’s safety. It was not immediately clear what impact Bayer’s decision would have on the studies.
The FDA in April limited the sale of Essure to healthcare facilities that provide full information about the device’s risks and benefits.
Kirby Dick, Amy Ziering and Amy Herdy, the award-winning filmmakers behind Netflix documentary ‘The Bleeding Edge’ on what they’ve discovered about Essure, say that in response to the recent protest by patients harmed by Essure, Bayer’s statement saying their “greatest priority” is patient safety is disingenuous and self-serving.
Dick, Ziering and Herdy write in The Daily Beast: “If Bayer truly cared about women’s safety, they would remove Essure from the market. Period. Instead, Bayer opted to trot out several of its time-worn statements: ‘…our greatest priority is ensuring patient safety and the proper use of our products’ and ‘(an) extensive body of scientific evidence establishes that Essure is comparable in safety and effectiveness to tubal ligation.’
“The truth is, Bayer has falsely marketed Essure’s effectiveness and safety data, and as a result, tens of thousands of women around the world have suffered complications ranging from unintended pregnancy to having hysterectomy to have the device removed. Bayer need look no further than their own records and the FDA’s database for this evidence.
“In a January 2018 JAMA study, which addressed medical outcomes following hysteroscopic sterilisation – Essure, compared to tubal ligation, the study found that: ‘The risk of so-called ‘gynaecological complications’ – predominantly a need for another sterilisation procedure within a year – is well known to be higher with hysteroscopic sterilisation (Essure) compared to laparoscopic sterilisation.’”
They write: “Essure was approved under an ‘expedited review’ without randomised controlled trials, using two non-randomised, non-blinded, prospective studies that lacked a comparator group, enrolled a total of 926 women, and only followed them for 18 months, even though Essure is supposed to remain in place for a woman’s lifetime.
“And Bayer’s post-market surveillance of Essure is far from robust. For example, in one post-approval study, 30 percent of the original study group could not be followed for the full five years, so the data is misleading and incomplete.
Dick, Ziering and Herdy write: “The only constructive thing Bayer has said regarding Essure is that they ‘encourage women who have questions or concerns about Essure to seek proper medical advice from an experienced, board-certified obstetrician-gynaecologist.’
“We did exactly that. Board-certified obstetrician-gynaecologist Dr E Scott Sills says when it comes to Essure, he’s seen a range of side effects, many very dangerous. ‘Patients were gaining weight, they were having abdominal bloating, painful sex, they were having irregular bleeding,’ Sills told us. ‘They were having skin problems, hair loss, fatigue… They (Essure devices) puncture the fallopian tube and get into the abdominal cavity and snag the fallopian tube and go up to the liver… I’ve seen this happen in my practice.’
Importance: Safety of hysteroscopic sterilization has been recently questioned following reports of general symptoms such as allergy, tiredness, and depression in addition to associated gynaecological results such as pelvic pain, perforation of fallopian tubes or uterus, and unwanted pregnancy.
Objective: To compare the risk of reported adverse events between hysteroscopic and laparoscopic sterilization.
Design, Setting, and Participants: French nationwide cohort study using the national hospital discharge database linked to the health insurance claims database. Women aged 30 to 54 years receiving a first hysteroscopic or laparoscopic sterilization between 2010 and 2014 were included and were followed up through December 2015.
Exposures: Hysteroscopic sterilization vs laparoscopic sterilization.
Main Outcomes and Measures Risks of procedural complications (surgical and medical) and of gynaecological (sterilisation failure that includes salpingectomy, second sterilization procedure, or pregnancy; pregnancy; reoperation) and medical outcomes (all types of allergy; autoimmune diseases; thyroid disorder; use of analgesics, anti-migraines, antidepressants, benzodiazepines; outpatient visits; sickness absence; suicide attempts; death) that occurred within 1 and 3 years after sterilization were compared using inverse probability of treatment–weighted Cox models.
Results: Of the 105 357 women included (95.5% of eligible participants; mean age, 41.3 years [SD, 3.7 years]), 71 303 (67.7% ) underwent hysteroscopic sterilization, and 34 054 (32.3%) underwent laparoscopic sterilization. During the hospitalization for sterilization, risk of surgical complications for hysteroscopic sterilization was lower: 0.13% for hysteroscopic sterilization vs 0.78% for laparoscopic sterilization (adjusted risk difference [RD], −0.64; 95% CI, −0.67 to −0.60) and was lower for medical complications: 0.06% vs 0.11% (adjusted RD, −0.05; 95% CI, −0.08 to −0.01). During the first year after sterilization, 4.83% of women who underwent hysteroscopic sterilization had a higher risk of sterilization failure than the 0.69% who underwent laparoscopic sterilization (adjusted hazard ratio [HR], 7.11; 95% CI, 5.92 to 8.54; adjusted RD, 4.23 per 100 person-years; 95% CI, 3.40 to 5.22). Additionally, 5.65% of women who underwent hysteroscopic sterilization required gynaecological reoperation vs 1.76% of women who underwent laparoscopic sterilization (adjusted HR, 3.26; 95% CI, 2.90 to 3.67; adjusted RD, 4.63 per 100 person-years; 95% CI, 3.38 to 4.75); these differences persisted after 3 years, although attenuated. Hysteroscopic sterilization was associated with a lower risk of pregnancy within the first year of the procedure but was not significantly associated with a difference in risk of pregnancy by the third year (adjusted HR, 1.04; 95% CI, 0.83-1.30; adjusted RD, 0.01 per 100 person-years; 95% CI, −0.04 to 0.07). Risks of medical outcomes were not significantly increased with hysteroscopic sterilization compared with laparoscopic sterilization.
Conclusions and Relevance: Among women undergoing first sterilization, the use of hysteroscopic sterilization was significantly associated with higher risk of gynaecological complications over 1 year and over 3 years than was laparoscopic sterilization. Risk of medical outcomes was not significantly increased over 1 year or over 3 years. These findings do not support increased medical risks associated with hysteroscopic sterilization.
Kim Bouillon; Marion Bertrand; Georges Bader; Jean-Philippe Lucot; Rosemary Dray-Spira; Mahmoud Zureik