Permanent hysteroscopic sterilization with Essure is an important contraceptive option, particularly for women who are poor surgical candidates. In our recent commentary,1 we agreed with the position statement made by the American College of Obstetricians and Gynecologists and the U.S. Food and Drug Administration's decision that there is insufficient scientific evidence warranting removal of Essure from the market. However, as we have previously demonstrated in women's health,2 high-risk medical devices are consistently approved with weaker evidence compared with pharmaceuticals. Furthermore, provisions in the recently passed 21st Century Cures Act will allow medical device regulation to become less stringent.3 Essure represents a case of how imperfect postmarketing surveillance mechanisms such as the Manufacturer and Device User Experience Database, coupled with a low bar for approval in the form of a single-arm prospective study, can fuel significant uncertainty over the safety and efficacy of a medical device. This is particularly apparent as the time from initial approval increases and devices approved by the premarket approval pathway, such as Essure, undergo numerous modifications in the form of supplements.
The point raised that the acquisition of Conceptus by Bayer in 2013 partly triggered the increase in mass consumer adverse event reporting in the Manufacturer and Device User Experience Database for financial motives is possible. However, 5 years before the acquisition of Conceptus by Bayer, a 2008 Supreme Court decision (Riegel v Medtronic) essentially provided device manufacturers with immunity from the majority of death or injury-related lawsuits for devices that underwent the premarket approval pathway as Essure did.4 More likely, the rise in Database reports was multifactorial, including contributions from social media,5 a 2013 label update by the U.S. Food and Drug Administration warning of the risk of chronic pain and device migration, new publications in the medical literature, or simply a time delay of clinically significant adverse events from implantation. Essure is a reminder that obstetricians and gynecologists must play a larger and more active role in ensuring device safety. All physicians and surgeons should strive to be more than mere end-users.