By Desiree Housek, Staff Writer
Bayer HealthCare’s contraception device, Essure, is believed to have been linked to more fetal deaths than was previously thought by the U.S. Food and Drug Administration (FDA).
After five years of clinical trials, the FDA approved the use of Essure as an alternative to tubal ligation in 2002. The procedure takes less than an hour for a doctor to perform, and consists of two metal coils that are inserted into the fallopian tubes blocking eggs from traveling into the uterus through the formation of scar tissue. The device has been associated with severe health problems, unwanted pregnancies, and fetal deaths.
After the FDA failed to act on complaints from thousands of women, a fast-growing Facebook movement began with over 27,000 women who are part of groups that are sharing their stories.
The movement has garnered the attention of celebrity activist Erin Brockovich and also prompted an FDA panel meeting.
Later this month, the agency is expected to make a decision on whether or not to restrict the use of the device or recommend additional clinical trials. Bayer continues to argue that the device has been shown safe and effective over years of clinical trials and that nearly 750,000 units have been sold.
If you have experienced health related problems or fetal death related to Essure and need a defective medical device attorney, visit our attorney database to find an experienced attorney near you.