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July 8, 2020: Postmarket Surveillance Results for Essure Birth Control Issued by FDA

Essure Postmarket Surveillance Results News – The U.S. Food and Drug Administration (FDA) has posted interim results for the postmarket surveillance study of Essure, a permanent implanted birth control device for women. Sales of Essure in the U.S. stopped in December 2018. Implantation of the Essure birth control device is no longer available as of December 2019.

Credit: Bayer

Essure Postmarket Surveillance Results Information

On July 8, 2020, the FDA issued its postmarket surveillance results for Essure. The FDA has continued to recommend that women who have been using Essure successfully can and should continue to do so. But, women who believe the device may be related to certain symptoms they have, such as persistent pain, should speak with their doctor about appropriate steps.

Patients should discuss the risks and benefits of any procedure with their doctor before deciding on the best course of action.

Per the FDA’s Essure update, Terri L. Cornelison, M.D., Ph.D., director of the FDA’s Health of Women Program in the Center for Devices and Radiological Health stated:

Early results show that Essure patients tend to have higher rates of chronic lower abdominal and/or pelvic pain and abnormal uterine bleeding compared to women who had laparoscopic tubal ligation as their permanent birth control. Also, patients with Essure had higher rates of gynecologic surgical procedures—including surgery to remove Essure—than patients who had tubal ligation. Lastly, pregnancy rates are similar for patients with Essure and tubal ligation.

In February 2016, the FDA ordered Bayer to obtain additional data about Essure’s benefits and compare them to laparoscopic tubal ligation. In December 2018, the FDA ordered Bayer to extend the postmarket surveillance study from three to five years. Enrollment in the study has ended, but the five-year follow-up of patients after their permanent birth control procedure is ongoing and patients are still completing their one-year follow-up visits.

FDA has issued multiple updates over the last several years to monitor the safety of Essure. The agency remains committed to sharing new information with the public about the postmarket safety of this device as it becomes available.

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