The U.S. Food and Drug Administration said it would discuss the safety and effectiveness of Bayer AG’s controversial contraceptive device, Essure, in a public panel meeting after receiving more than 5000 complaints, including those of deaths and pregnancies.
Essure, which is the only approved permanent birth control device in the United States, is a small metal coil placed in the fallopian tubes through a catheter. The FDA approved the device in November 2002.
In the near 13 years since then, the health regulator said it had received 5,093 complaints, including those of pain or menstrual irregularities after using the device, as well as complaints of the device breaking.
There have also been five fetal deaths in women who became pregnant after using Essure and four adult deaths for reasons such as infection and uterine perforation, the agency said.
The FDA said it plans to hold a meeting of the Obstetrics and Gynecology Devices Panel on Sept. 24 to discuss the risks and benefits of Essure and has invited feedback from presenters, panel members and the public.
The device has been used by about 750,000 women, according to Bayer’s website.
The FDA cautioned the complaints it received had limitations, such as incomplete or inaccurate data, and did not necessarily directly indicate a faulty or defective device.