(Reuters) — The U.S. Food and Drug Administration said it would discuss the safety and effectiveness of Bayer (ETR:BAYN) 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 that is 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 that the complaints it received had limitations such as incomplete or inaccurate data and did not necessarily directly indicate a faulty or defective device.
Last month, Bayer cited a 364-patient 5-year study of the device published in the Journal of Minimally Invasive Gynecology that indicated no pregnancies after 5 years and that the Essure inserts were “generally well tolerated.” Pelvic pain was reported in no more than 7% of patients, but no study participants reported persistent pelvic pain of any kind at the 3-, 4-, and 5-year follow-up visits, according to Bayer.
The study reported 3 serious adverse events “possibly related” to Essure in the trial, including irregular menstrual bleeding, lower abdominal pain and heavy periods and continuous bleeding. The latter 2 patients ended up having hysterectomies.
In February a citizens petition lodged with the FDA asked the safety regulator to take Essure off the U.S. market, alleging that the clinical data the FDA used to approve the device was fudged and that the company concealed adverse events associated with Essure.