Essure Birth Control Implant Gets Black Box Warning From FDA
The Food and Drug Administration announced Bayer Essure birth control implant devices must include a heightened warning for patients and doctors. The Essure birth control implant is a non-surgical permanent form of birth control. The implant resembles a small spring and is made of nickel-titanium coils. It is inserted into the Fallopian tubes and encourages the growth of scar tissue preventing fertilization.
Thousands of women with Essure birth control implants have filed adverse event reports with the FDA. Many of the women suffered serious injuries like organ perforation, device migration, severe pelvic pain, allergic or hypersensitivity reactions, and bleeding. In some cases, these implants had to be surgically removed.
The FDA will require Bayer to add a black box warning to the Essure implant label which lists the complications associated with the product as well as a Patient Decision Checklist to help ensure that women understand the risks and benefits of these birth control implants. The FDA also ordered Bayer to conduct a postmarket study of Essure to gather additional information about the risks and benefits of these implants.
If you or someone you know suffered serious complications after receiving an Essure birth control implant, contact us. Cohen & Malad, LLP product liability attorneys have experience litigating claims against large medical device and pharmaceutical manufacturers and can advise you of your legal rights and options.