FDA posts a surveillance report on Bayer’s birth control implant-Essure
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
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 US.
Since February 2016, the birth control implant was under the FDA surveillance as part of the postmarket surveillance (“522”) study as many patients came forward with complaints of side-effects and long time issues.
Therefore, 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 enrolment 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
Says Terri L Cornelison, Director- FDA’s Health of Women Program in the Center for Devices and Radiological Health, “Although Essure is no longer available for implantation in the US, 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”, she added.
“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”, she further informs.
Currently, the FDA is working with Bayer 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”, Cornelison sums up.
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.