The Essure device, which was approved by the Food and Drug Administration (FDA) in 2002, was intended to be a permanent method of birth control. A health care provider would insert the device, a set of flexible nickel-titanium coils, into a patient’s fallopian tubes. Over several months, scar tissue would build up around the coils and block the fallopian tubes, preventing fertilization. Unlike other intrauterine birth control devices, Essure was intended to remain in place permanently, and was celebrated as the only nonsurgical, nonhormonal, permanent form of approved birth control for women.
Bayer sold the device internationally; since 2002, more than 750,000 women across the globe have had the device implanted. However, there were complaints right from the start. Bayer initially warned patients that they could experience allergic reactions to the nickel, suffering from itching, swelling, and rashes, among other things. Several advocacy groups reported more serious concerns, including weight changes, depression, muscle weakness, hair loss, depression, fatigue, and perforation of the uterus or fallopian tubes. Over the years, Essure has been the subject of 16,000 lawsuits and 27,000 complaints. The complaints (and the persistence of women advocating for their health) led the FDA to add a “black box” warning (alerting consumers to the most serious potential side effects) to the device’s packaging in 2016. With sales falling and concerns growing, Bayer decided to stop marketing the device outside the U.S. by September 2017.
Finally, on Friday, July 20, Bayer announced that it would stop selling the Essure device by the end of 2018. While the company maintains that research demonstrated that the device’s benefits outweigh its risks, consumer advocates assert that data does not support these claims. Bayer’s decision to finally pull Essure from the U.S. market may not be an admission of liability, but it does show the power of persistent, often grass-roots advocacy.