Essure Birth Control Lawsuit Attorneys Serving the Indianapolis Area
Bayer began selling Essure contraceptive implants in late 2002. Essure is a non-surgical, permanent form of birth control for women. It is a medical device that resembles a small spring and is made of nickel-titanium coils. It is implanted in both Fallopian tubes and encourages the growth of scar tissue to block the Fallopian tubes and prevent pregnancy.
Serious injuries reported to the FDA
The FDA has collected thousands of injury reports from women who received Essure contraceptive devices. Many of these women suffered serious injuries and complications related to Essure including organ perforation, device migration, severe pelvic pain, allergic or hypersensitivity reactions, and bleeding. In some cases, these implants had to be surgically removed. Other women suffered such severe injuries that hysterectomy surgeries were necessary.
FDA requires black box warning for Essure
The FDA took action to protect women after receiving numerous injury reports associated with Essure contraceptive devices. The agency held an Advisory Committee Meeting to further review and evaluate the benefits and risks for patients using Essure as a method of birth control.
One of the first actions the agency took following its meeting was to order Bayer to conduct a post-market surveillance study of Essure to obtain more data related to the risks and benefits of this device. The post-market study is said to enroll more than 2,000 women who will be evaluated for a minimum of three years and will compare the Essure implant to tubal ligation.
The FDA also issued a safety notice in early 2016 for a black box warning to be added to Essure contraceptive implants warning healthcare professionals and patients of the increased risk for serious injury associated with these devices. It also stated a Patient Decision Checklist should be added to product labeling to help ensure that the patient receives and understands the benefit and risk information related to the Essure contraceptive device.
In addition to these steps, the FDA also issued a draft guidance “Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization” to give the public an opportunity to comment on the proposed language included in the warnings.
Essure Contraceptive Lawsuits
Injured women are stepping forward to file lawsuits against Bayer for failing to warn them of the serious risks associated with Essure contraceptive implants. Cohen & Malad, LLP product liability attorneys have experience litigating cases against large companies like Bayer and can provide you with a FREE case evaluation and advise you of your legal rights and options. Contact us.