FDA Provides Update on Bayer's Essure, Withdrawn Contraceptive Device

The FDA has issued an update on Bayer’s Essure intrauterine birth control device, which was withdrawn from the U.S. market on Dec. 31, 2018.

The most recent data from a postapproval study showed the rate of device removal globally for any reason was 17.8 percent at eight years, the agency said.

Last September, the FDA said it had received 9,855 reports of a foreign body or device fragment in patients with the permanently implanted device from 2002 through 2020.

Despite the reported problems, the agency said that women who have been using Essure successfully to prevent pregnancy “can and should continue to do so.”