Thousands of women have filed lawsuits against Bayer alleging that Essure, the permanent birth control device, caused complications. The device has gained more attention in light of complaints from numerous women, many of whom took to social media to express their concerns. The Facebook group “Essure Problems” sparked initial media attention in 2013.
In addressing these concerns, the U.S. Food and Drug Administration (FDA) held an advisory panel to discuss the risks and benefits of Essure last fall. The independent panel of experts concluded that there was not enough data to show that Essure is safe, and said its use should be limited. The FDA has since added a black box warning to Essure.
Plaintiffs say that Bayer marketed Essure as a non-surgical option for women who no longer want to have children. Essure consists of two metal coils, each is inserted into a fallopian tube. The idea is that fertilization will be blocked when scar tissue grows around the coils. The FDA approved Essure in 2002.
Alleged injuries from Essure include headaches and migraines, heavy bleeding, nausea, fatigue, organ perforation, metal allergies, severe depression and device failure leading to unwanted pregnancy and miscarriage.
Famed advocate Erin Brockovich is supporting Essure users in their fight against Bayer. The company has been accused of dodging liability by citing pre-market approval rules.
Proposed legislation, however, may make it easier for plaintiffs. Congressman Mike Fitzpatrick and Congresswoman Louise Slaughter introduced a bill on Jun. 8 called “Ariel’s Grace Law” which would allow women to hold Bayer accountable for Essure-related injuries. The legislation is named after Ariel Grace, who was allegedly conceived due to Essure failure and died in the womb at 27 weeks gestation.
The congress members also introduced the Medical Device Guardian’s Act of 2016, which would require physicians to report injuries associated with medical devices. The bill would also protect doctors from personal liability when they report these injuries. In the past, hospitals have allegedly discouraged doctors from reporting medical device hazards due to the risk of liability.