FDA In Brief: FDA Posts Interim Results from Required Essure Postmarket Surveillance Study
July 8, 2020
Media Inquiries: Alison Hunt 202-308-5496
The following quote is attributed to Terri L. Cornelison, M.D., Ph.D., director of the FDA’s Health of Women Program in the Center for Devices and Radiological Health:
“Although Essure is no longer available for implantation in the U.S., the FDA remains committed to evaluating long-term safety information in women who have received the device, including data from an FDA-required postmarket surveillance study.”
“Today we’re providing important early overall results—from patients at varying points of follow up—from that prospective study to help patients and health care providers better understand complications women with Essure may experience. ”
“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.”
“The FDA is working with Bayer, Essure’s manufacturer, to modify its study to include an additional interim analysis at one year of follow up after patients’ permanent birth control procedure—this is earlier than the previously planned analysis at three years. We believe this change is important to continue to closely monitor patient outcomes and communicate about the results in a more meaningful way.”
- Today, the FDA posted interim results for the postmarket surveillance ("522") study on Essure, a permanently implanted birth control device for women that, after December 2019, has no longer been available for implantation in the U.S. Sales of Essure in the U.S. were discontinued in December 2018.
- The FDA continues to recommend that women who have been using Essure successfully to prevent pregnancy can and should continue to do so. Women who suspect the device may be related to symptoms they are experiencing, such as persistent pain, should talk to their doctor about what steps may be appropriate. Device removal has its own risks. Patients should discuss the benefits and risks of any procedure with their health care providers before deciding on the best option for them.
- In February 2016, the FDA ordered Bayer to gather more data about Essure’s benefits and compare them to laparoscopic tubal ligation. In December 2018, the FDA required Bayer to extend the postmarket surveillance study from three years to five years.
- While enrollment in that study has ended, the five-year follow-up of patients after their permanent birth control procedure is ongoing and patients are still completing one year follow up visits.
- The FDA has taken a number of actions over the last several years to monitor the safety of Essure. The agency has regularly updated the public about these and remains committed to sharing new information with the public about the postmarket safety of this device as it becomes available
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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.