Essure (Bayer) is the only nonsurgical, permanent contraceptive available in the US. The coil-like devices are placed hysteroscopically in both fallopian tubes and, after several months, scar tissue causes tubal occlusion.1 In 2016, the FDA required Bayer to revise the device's labeling to include a patient decision checklist and a boxed warning about the risks of uterine and fallopian tube perforation, migration of the device to the abdominal or pelvic cavity, persistent pain, and hypersensitivity reactions. Some women were apparently not being informed of these risks before implantation of the device, which can only be removed surgically. As a result, the FDA is now restricting the sale and distribution of Essure to healthcare providers who agree to review the "Patient-Doctor Discussion Checklist – Acceptance of Risk and Informed Decision Acknowledgement" with their patients before implantation. The checklist includes information about the device, its safety, and its effectiveness. Patients and physicians must sign the checklist before the device is implanted.

1. Choice of contraceptives. Med Lett Drugs Ther 2015; 57:127.
2. FDA activities: Essure. Available at: www.fda.gov. Accessed May 10, 2018.