The United States Food and Safety Administration (FDA) required Essure, a birth control device, to secure a new "black box warning" label. The implantable permanent contraceptive device has received numerous complaints since it was approved in 2002.
According to CNN, black box warning signals a possible life-threatening risk associated with the use of the product as defined in the FDA website. The FDA announced last Feb. 29 that more than 5,000 cases had been filed between November 2002 and May 2015.
These women allegedly experienced pregnancies despite using the contraceptive, miscarriages and stillbirths. After implanting Essure, there were also complaints of severe pain and bleeding, menstrual irregularities. Mass Device added that there were four cases of death due to infection and uterine perforation, as per FDA.
Dozens of women file suit over Essure health risks https://t.co/ItN77VO8aS pic.twitter.com/qaWUaaAb5D
— KSDK NewsChannel 5 (@ksdknews) March 18, 2016
What is Essure?
As described by CNN, Essure is a form of birth control that is permanently placed inside a woman's body. Manufactured by Bayer, Essure is a small metal coil that is non-surgically placed into a woman's Fallopian tube after which, scar tissues should form around the device. This will serve as a protective barrier against the sperm, preventing fertilization.
In the last three years, there was a 1,400 percent increase in complaints filed against Essure according to FDAs Obstetrics & Gynecology Devices advisory panel meeting. Bayer's director of global pharmacovigilance risk management, Dr. Andrea Machliit, informed the panel that the company has received 17,000 reports. Considering this data, the panel has recommended the limited use of Essure until further evidence for its safety is established.
In October 2015, a study suggests that women implanted with Essure were found to be 10 times more likely to undergo post-procedure surgery compared to those who underwent laparoscopic sterilization. There was already a proposed bill filed last year by Rep. Mike Fitzpatrick to altogether ban U.S. sales of Essure.
FDA's New Recommendation
Aside from the black box warning, the FDA has required Bayer to conduct a trial to determine the increased risk for women. The agency required Bayer to follow more than 2,000 women for at least three years. The participants will not be limited to Essure users, rather it will also include users of other forms of birth control. Within 30 days, Bayer must submit a study protocol and roll out the study within 15 months per CNN report.
The FDA also required Bayer to provide a patient decision checklist that will be signed by patients and doctors. Three months after implantation, the women would undergo testing to make sure the device is intact and functioning. Check out this video on how to implant Essure:
