FDA is convening the panel to seek expert scientific and clinical opinion on the risks and benefits of Essure. The Food and Drug Administration (FDA) has announced that the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee will meet on September 24, 2015 to discuss the risks and benefits of Bayer HealthCare’s Essure birth control system.
The FDA is convening the panel to seek expert scientific and clinical opinion on the risks and benefits of Essure, a method for nonsurgical permanent female sterilization. The committee will be asked to evaluate scientific evidence about the safety and effectiveness of the Essure System, including perforation/migration of the device, device removal, chronic pain, allergic reactions, unintended pregnancy, and ectopic pregnancy. The committee will provide recommendations about appropriate use of the device, product labeling, and the potential need for additional postmarket clinical studies.
Essure received FDA approval in November 2002. Bayer HealthCare Pharmaceuticals’ online materials say the implant procedure can be done on an outpatient basis in a doctor’s office and takes about 10 minutes to perform. In a doctor’s office, small nickel-titanium coils are inserted through the vagina into the woman’s fallopian tubes. They cause scar tissue to form, which eventually blocks the tubes, preventing pregnancy. Three months after the procedure, the woman has a follow-up X-ray using dye to confirm that the tubes are fully blocked, National Public Radio (NPR) reports. Once blockage is confirmed, the method is considered 99.83 percent effective.
Women who have received the implant have reported a variety of injuries and side effects
Women who have received the implant have reported a variety of injuries and side effects they say were caused by Essure, including unintended pregnancies and ectopic pregnancies (where the embryo implants somewhere other than the uterus). Ectopic pregnancy can be life-threatening. One woman who had Essure implanted in September 2010 told NPR she experienced chronic fatigue, migraines, joint pain, digestive issues, back pain, heavy periods full of clots, difficulty concentrating, abdominal pain, hair loss, tooth deterioration, depression, and severe bloating. A
Facebook group has posts from more than 18,000 women who have experienced symptoms they attributed to Essure. Though Essure is designed to be permanent, many women have had the device removed, according to NPR.
The meeting will be held at the FDA’s campus in Silver Spring, Maryland and will be open to the public. The FDA intends to make background material available to the public no later than two business days before the meeting. Interested persons may present material orally or in writing. Written submissions may be made on or before September 4, 2015.
Anyone interested in making an oral presentation should submit a brief statement of the general nature of the presentation on or before August 24, 2015. If the number of people requesting to speak is greater than can be accommodated during the open public hearing session, the FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session.
The contact person will notify interested persons regarding their request to speak by August 28, 2015. Electronic comments may be submitted to http://www.regulations.gov, and written comments should be sent to the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.