February 23, 2017 — Bayer’s sterilization implant Essure has been banned and recalled in Brazil, but it remains on the market in the U.S. despite a massive grassroots campaign.
Brazil’s health regulatory agency Anvisa recalled all Essure implants that were already sold, pulled it off the market, and banned importation, distribution, marketing, and sales.
The recall took effect on February 17. Anvisa also posted a safety warning on their website in Portuguese, which translates as:
“[Essure] is classified as maximum-risk. It can cause changes in menstrual bleeding, unwanted pregnancy, chronic pain, perforation and migration of the device, allergy and sensitivity, or immune-type reactions.”
Essure was approved in Brazil in 2009, but Anvisa did not say how many were distributed in the country. Bayer estimates that 900,000 have been sold worldwide, with about 70% of those in the U.S.
Essure has not been recalled in the U.S., despite around 10,000 reports of injuries and deaths, hundreds of pregnancy losses, and the largest grassroots campaign to get a medical device off the market since silicone breast implants in the 1980s and 1990s.
That campaign includes 900 women who joined lawsuits, 30,000 women in the Facebook group “E-Sisters,” publicity from Erin Brockovich, and bipartisan legislation to recall Essure introduced by Mike Fitzpatrick (R-PA) and Louise Slaughter (D-NY).
Instead of a recall, the FDA added a “Black Box” warning, created an optional “Patient Decision Checklist,” and required Bayer to study Essure’s risks and compare it to tubal ligation.
This lack of action has infuriated thousands of women who say Essure is dangerous. It is a Class III (“maximum-risk”) medical device that was given fast-track approval specifically for a small number of women who wanted to be sterilized but could not have surgery.
The FDA said Essure “remains an appropriate option for the majority of women seeking a permanent form of birth control,” but “some women may be at risk for serious complications” in a statement last year announcing safety studies.
It will be a few years before those studies are complete, but independent studies have already been extremely concerning — one in 2015 linked Essure with a 10-fold increased risk of needing follow-up surgery compared to women who were sterilized with tubal ligation.