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FDA To Review Sterilization Device

FDA To Review Sterilization Device

September 23, 2015 — FDA on Thursday will hold a public hearing to review the safety of Essure, a permanent implant that is inserted into the fallopian tubes to cause sterilization, the Washington Post reports.

Essure is a nickel-titanium coil inserted into the fallopian tubes in a 15-minute procedure. Over three months, tissue builds up around the devices and blocks off the tubes. FDA approved Essure in 2002 but has since required updates to Essure's labeling, including risk disclosures for a chance of pregnancy after implantation and for chronic pain, as well as a warning to women with sensitivity to nickel.

Bayer HealthCare Pharmaceuticals acquired Essure in 2013 and has since faced several lawsuits and received more than 5,000 reports of complications related to the implant, according to the Post. In addition, a Facebook group with more than 20,000 members shares stories of women who have experienced issues with the device. Bayer estimates that about 750,000 women have received the implant worldwide.

FDA said it has examined multiple studies about the implant and has "found no conclusive evidence in the literature indicating any new or more widespread complications definitely associated with Essure." However, the agency said it will continue "to make certain that its benefits of providing women with a non-incisional sterilization choice continue to outweigh its risks" (Dennis, Washington Post, 9/21).