Revisiting Essure — Toward Safe and Effective Sterilization

Essure, a female-sterilization device, is being reevaluated by an FDA panel 13 years after its original approval. Would concerns about its safety and effectiveness have been addressed earlier with better research and result dissemination? Permanent sterilization is the second-most-common contraceptive approach used by women in the United States, undergone by about 345,000 women per year. For many decades, laparoscopic surgery was the standard of care. In 2002, a novel hysteroscopic sterilization device was made available after expedited review and premarketing approval by the Food and Drug Administration (FDA): the Essure System (Bayer). With Essure, a coil designed to induce fibrosis and tubal occlusion is placed into each fallopian tube to prevent fertilization. Three months after placement of the coil, women undergo hysterosalpingography to confirm device placement and occlusion before discontinuing use of other contraceptive . . .