Thousands of women successfully using Essure, a flexible implantable device, as their permanent choice for contraception are looking for answers now that its manufacturer, Bayer, has opted voluntarily to stop selling it in the U.S. at the end of this year.
Here's what you need to know: If you are not experiencing discomfort or side effects with Essure, then you may continue to rely on the device.
Of course, if you have questions, your first stop should always be your health care professional (HCP). Bayer is also offering support services on its websites and via a customer call center (1-888-84-BAYER.)
As an HCP myself, I, too, have Essure questions, so I reached out to Dr. Yesmean Wahdan, deputy director of Women's Healthcare Medical Affairs at Bayer to find out more.
Here is what women using Essure need to know:
Beth: Essure has been available for more than a decade as the only nonsurgical option for permanent contraception. Can you give me a brief history of the device?
Dr. Wahdan: Essure was initially approved in 2002 under FDA's premarket approval review, the agency's most rigorous pathway for medical devices. Essure's favorable safety profile has been established by more than 40 published studies, conducted by Bayer and by independent researchers, involving more than 200,000 women in pre- and post-approval clinical trials and real-world observational studies over the past 20 years.
The data show that the vast majority of Essure patients are satisfied. In the phase II and pivotal trials, at follow-up time points that spanned five years, at least 99 percent of women were reported to have rated comfort of wearing the Essure inserts as "good" or "excellent."
With that said, all birth control options have risks, and Essure's potential risks have been clearly communicated to doctors in the product's "Instructions for Use (IFU)" since its approval in 2002.
Today, the FDA continues to believe that the benefits of the device outweigh its risks. As part of its executive summary, FDA provided a "comprehensive overview of clinical literature" and "found no conclusive evidence indicating any new or more widespread complications definitely associated with Essure."
Beth: And yet, the agency issued a black box warning for Essure in 2016 and placed restrictions on its sale. Why?
Dr. Wahdan: In 2016, despite finding "no conclusive evidence indicating any new or more widespread complications definitely associated with Essure," FDA required the addition of a boxed warning to the device's IFC. FDA stated that adding the boxed warning was to "ensure that a woman receives and understands information regarding the benefits and risks of this type of device prior to undergoing implantation."
The boxed warning specifically tells physicians: "This information should be shared with patients considering sterilization with the Essure System for Permanent Birth Control during discussions of the benefits and risks of the device." While the boxed warning refers to certain potential risk events, each of these potential risks were disclosed in Essure's original IFU issued in 2002.
In April 2018, following allegations that some physicians were still not adequately communicating the potential risks of Essure to their patients, FDA imposed a further restriction, requiring that physicians use a patient-doctor discussion checklist with their patients before they are permitted to purchase Essure.
The benefit-risk profile of Essure has not changed and remains positive.
Beth: Is there a way for a woman using Essure to check its integrity once implanted?
Dr. Wahdan: After a doctor places Essure in a patient's fallopian tubes, she is directed to return to her physician in three months to have an Essure confirmation test. This test is an important and necessary part of the Essure permanent birth control procedure.
The test can be done by either transvaginal ultrasound or modified hysterosalpingogram (HSG), and its purpose is to ensure that the Essure inserts are properly located in the fallopian tubes and, with HSG, that the tubes are sufficiently blocked, so that a woman can rely on Essure for birth control. Until this confirmation test is complete, a woman must remain on alternative contraception.
Beth: If a woman wants to have her Essure device removed, what would that entail?
Dr. Wahdan: If women have questions, Bayer encourages them to discuss them with their physician before making any medical decisions. There is no evidence to support removal of the device in asymptomatic women.
It also is important to emphasize that all surgical procedures, including removal of the Essure device, are associated with risks—some of which are potentially serious, and [removal] should only be performed by a trained surgeon.
This interview has been edited and condensed.