The Food and Drug Administration (FDA) announced that it will launch an investigation into the safety of the birth control device Essure. The FDA’s decision comes after receiving a Citizen’s Petition, signed by more than 2,100 women, which urged the FDA to remove Essure from the market. The agency closed the petition and sent it to the Office of Compliance for further investigation of the claims made against Essure. Following its investigation, the FDA will decide whether further action is necessary.
What is Essure?
Essure is a birth control device that has been on the market since 2002. Developed by Conceptus, Inc., a subsidiary of Bayer AG. Essure is marketed as a permanent birth control to women who do not wish to have any more children. The device uses metal coils placed by a gynecologist into the fallopian tubes to form a “natural barrier” to prevent pregnancy. The women’s tissue grows into the metal coils, thereby blocking conception. Approximately, 750,000 of the devices have been sold around the world.
The Citizen’s Petition was submitted to the FDA in January. The allegations in the petition are similar to the claims made in pending lawsuits against Bayer Healthcare, the manufacturer of Essure. The petition claims that the manufacturer of the device perpetrated fraud during the clinical trials, violated the terms of the FDA’s pre-market approval of the device, and violated federal laws in the manufacturing and marketing of Essure. The petition requests the FDA to do the following:
- Issue orders relating to disclosures and findings;
- Modify its pre-market approval terms for the device; and
- Initiate a recall.
A group of women associated with the Facebook group called Essure Problems, which is focused on problems linked to Essure, had an official meeting with the FDA on April 2. The meeting included representatives from the FDA’s Office of the Commissioner, Women’s Health, Compliance, Chief Counsel and other departments, as reported by one article. During this meeting, the women expressed their concerns and experiences with Essure. The Facebook group was created so that women who have been affected by Essure could come together and share their experiences. It has over 14,000 members.
Adverse Events Related to Essure
The FDA has received thousands of complaints and hundreds of reports of adverse events related to Essure. The most frequently reported problems related to the device are:
- Menstrual irregularities
- Weight fluctuations
In some cases, the metal coils of Essure cut into the woman’s organs. Essure has also caused some women to experience unplanned pregnancies and, in some cases, miscarriages. Prior to the Citizen’s Petition, the FDA reviewed the results of a five-year study that was conducted by Conceptus and reported that there was no evidence of new safety problems or an increased incidence of problems already known.
Essure was granted pre-market approval by the FDA in 2002. Because of its pre-market approval status, many women who are experiencing problems with the device are struggling to find redress in courts. You can read more about the Essure device here.