February 23, 2017 — The Brazilian health regulator Anvisa has banned sales and recalled Essure, Bayer’s controversial permanent sterilization implant.
Anvisa recalled all Essure implants that were already distributed and suspended importation, distribution, marketing, and dissemination of Essure on February 17.
Anvisa also issued a recall warning on their website in Portuguese. The translation reads:
“The contraceptive system 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.”
Anvisa did not say how many women in Brazil were implanted with Essure, but it was approved in the country in 2009. The original manufacturer, Conceptus Inc., was acquired by Bayer in 2013. Bayer estimates that 900,000 Essure implants have been distributed worldwide, with about 70% of those sold in the United States.
Last year, the FDA refused to recall Essure in the U.S. — leaving many people wondering what it would take. Essure has sparked one of the largest public efforts in U.S. history to get a medical device off the market since silicone breast implants in the 1980s and 1990s.
The grassroots campaign includes 30,000 “E-Sisters” on Facebook, publicity from Erin Brockovich, and legislation from Mike Fitzpatrick (R-PA) and Louise Slaughter (D-NY). The FDA also has 10,000 reports injuries and deaths, including hundreds of pregnancy losses. Over 900 women have joined Essure lawsuits in California, with lawyers challenging Bayer’s legal immunity.
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 issued in February 2016.
Essure is a Class III (“high-risk”) medical device that was fast-tracked through the approval process specifically for a tiny number of women seeking a permanent form of birth control: Women who could not have surgery who decided to undergo an elective sterilization procedure.
When Essure hit the market in 2002, it was advertised as a quick 30-minute non-surgical outpatient procedure for busy women, with less pain and faster recovery than tubal ligation (“having your tubes tied”). As a result, the number of women who picked Essure over a tubal ligation skyrocketed. So did the number of injuries and complaints.
Instead of a recall, FDA added a “Black Box” warning label, created an optional “Patient Decision Checklist,” and required Bayer to study the risks of Essure for particular women and compare it to tubal ligation. Bayer’s studies will take years, but in 2015, another study of 52,000 women in New York found a 10-fold increased risk of follow-up surgery for women who were sterilized with Essure instead of a tubal ligation.