Brazilian public health agency Anvisa announced Feb. 20, 2017 that it has suspended and recalled the permanent contraceptive device Essure® due to mounting complaints that the device has caused severe complications, and even death, in thousands of women.
Anvisa stated that it was suspending the importation, distribution and marketing information of Essure.
The U.S. Food and Drug Administration ordered Essure manufacturer Bayer to include a black box warning on labels, the highest warning reserved for products that may cause serious injury or death, in 2016. A ban similar to Brazil’s, however, has not currently been implemented in the U.S.
Essure, a permanent fallopian tube implant, has been linked to severe complications including chronic pelvic pain, life-threatening ectopic pregnancy, device migration, perforation or tear of pelvic organs, and other effects requiring surgery to repair. Bayer has denied allegations questioning the safety and efficacy of the device.
Motley Rice medical attorney Fidelma Fitzpatrick serves as lead counsel of the Plaintiffs’ Executive Committee for Essure cases coordinated in California state court. If you or a loved one suffered severe complications after being implanted with Essure, you may contact her by email.