FDA updates on post-market study revisions, oversight for Bayer’s Essure

The FDA today released steps it is taking to maintain its oversight of Bayer‘s (ETR:BAYN) Essure permanent birth control device following its removal from the U.S. market this summer, including extensions and revisions to a required post-market study of the device.

In an official posting, FDA Commissioner Dr. Scott Gottlieb said the FDA is working with Bayer to “revise and strengthen” its post-market study of Essure, which was ordered by the federal watchdog in 2016.

The trial will now follow patients who received the Essure device for five years rather than the initially requested three years, giving the agency “longer-term information on adverse risks of the device, including issues that may lead women to have the device removed,” Gottlieb wrote in the posting.

The agency said that it will also require additional blood testing for patients on follow-up visits to study levels of inflammatory markers that can indicate increased inflammation, with hopes that it will help evaluate immune reactions to the device and and their associations with reported symptoms.

The FDA said it will also require Bayer to continue to enroll patients who opt to receive the Essure device “in advance of its full discontinuation from the U.S. market” and to submit “more frequent” reports on the study’s progress.

“We believe that this new, revised study plan will help provide more long-term information regarding complications that may be experienced by patients who have Essure, despite reduced enrollment,” Gottlieb wrote in the posting.

The FDA added that in addition to the post-market study, it will “continue its efforts to monitor Essure’s safety and effectiveness since its approval in 2002 by reviewing the medical literature, clinical trial information, post-approval study data and medical device reports submitted to the agency.”

“We believe women who’ve 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 on 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. The FDA will continue to collect and review reports of adverse events associated with device removal and is committed to continuing to provide updates on our evaluation of this data as the information is collected and we develop new findings about the device,” Gottlieb wrote in the posting.

In August, a group of Australian women joined others worldwide in a a class action lawsuit against Bayer for medical problems allegedly associated with its Essure device, according to a report from The Guardian.

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