The Controversy Over Essure Birth Control
AbstractWhen the Food and Drug Administration approved Essure for market release in 2002, the medical community held its breath. Essure was a revolutionary, non-surgical form of women’s permanent birth control that could be implanted in 20 minutes with only two days of recovery time. Further, the Essure device boasted the ability to make sterilization accessible to women who are unable to undergo surgery. In the years after the device’s approval, a percentage of women began vocalizing adverse health effects they had experienced after having the device implanted. By 2018, the Facebook support group called “Essure Problems” had accumulated over 40,000 members. This case investigates the intricacies of the FDA’s premarket approval process for medical devices, Essure’s journey through premarket approval and its time on the market, and the FDA’s responsibility to promote public health without stifling medical innovation. Ultimately, the FDA faced the dilemma of responding to the real and vocal concerns of the “Essure Problems” women considering clinical evidence and informed consent. After the FDA first attempted to ameliorate the issue by introducing a patient decision checklist and a black box warning, Bayer decided to discontinue sales of Essure in 2018, citing a decline in sales. Despite the inadequacies of the current FDA medical device approval process revealed in this case, the FDA continues to allow potentially dangerous medical devices to enter the market. Women throughout history have found strength in numbers when faced with injustice, a trend that is evolving and expanding with the growing accessibility of social media.