In what has become commonplace in the world of regulatory affairs, the FDA has issued guidelines concerning a controversial birth control device that are non-binding on the manufacturer (Bayer) and unenforceable. The useless guidelines have come under withering criticism from consumer safety advocates and women who’ve been injured by the dangerous device.
The Essure Birth Control System became available on the market in 2006. The system consists of two metal coils health care providers implant in a woman’s fallopian tubes. After about three months, scar tissue builds up around the implants and prevents pregnancy. Since its introduction, Essure has been controversial and complaints about the device have been numerous and well-documented.
In September 2015, the FDA convened a meeting which included women who had been injured by the birth control device, Bayer representatives, and members of FDA’s own Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee.
The FDA issued a draft set of guidelines in February 2016 concerning Essure and published the final version of the guidelines this past October. The guidance recommends a black-box warning, the most severe warning, and acknowledges possible adverse events linked to Essure, including perforation of the uterus, device migration, persistent pain and metal sensitivity reactions. The agency also recommends a patient decision checklist to help women decide if Essure is right for them.
Yet, the guidelines are non-binding and not legally enforceable. One could rightly wonder why the FDA bothered to issue guidelines if they had no force of law behind them.
Prior to the issuance of the final guidelines, the FDA received a report from an independent agency regarding Essure’s safety. It found that the agency failed to report more than 300 fetal deaths linked to the device. Previously, the FDA only reported five deaths.
Analyst Madris Tomes, founder and chief executive officer of Device Events, worked with Pennsylvania Congressman Mike Fitzpatrick to expose the data. Tomes also uncovered more than 10,000 adverse events. Mike Fitzpatrick issued a statement regarding the FDA’s non-binding recommendations.
“The latest recommendations from the FDA do not go far enough. A boxed warning and patient checklist highlight the severe risks of Essure — but they’re not legally enforceable requirements,” Fitzpatrick said. “Tens of thousands of women have been harmed by this unsafe medical device, including hundreds of fetal deaths.”
Essure Problems, a public safety advocacy group, has become so frustrated with the toothless tiger FDA and Bayer that it has announced it is no longer willing to work with either. Meanwhile, more women are injured by a dangerous medical device because the FDA won’t do its job and Bayer isn’t interested in acting like a responsible corporate citizen. It would rather focus on profits, especially if the FDA is going to give them a free pass.