FDA wants the public to know it is taking steps to make sure the long-term safety profile of a controversial birth control device continues to be studied even after U.S. sales of the device are discontinued at the end of the year. While this seems like a good idea, in theory, patient advocates have concerns about the validity and feasibility of the required post-market study.
Bayer announced in July that it would stop selling the Essure device at the end of the year due to a decline in U.S. sales. FDA Commissioner Scott Gottlieb said at the time that the agency would still hold the company responsible for meeting its postmarket obligations concerning the device, which includes a postmarket study to assess the long-term safety of the product. This week the agency took the additional step of making Essure a restricted device, even though the company plans to discontinue sales.
The agency also is making Bayer study patients out to five years, rather than the three years that was initially required. The extension will provide FDA with longer-term information on adverse risks of Essure, including issues that may lead women to have the device removed, Gottlieb said in a statement issued this week.
FDA is also requiring additional blood testing of patients enrolled in follow-up visits during the study to learn more about patients’ levels of certain inflammatory markers that can be indicators of increased inflammation. "This could help us better evaluate potential immune reactions to the device and whether these findings are associated with symptoms that patients have reported related to Essure," Gottlieb said.
However, the agency also said it realizes that Bayer may not be able to enroll enough patients in the required study, given the decline in sales and the company's decision to pull Essure from the market at the end of the year. FDA is allowing a reduction in the number of required patients in the study. As of Dec. 3, 791 patients have been enrolled (293 in the Essure arm and 498 in the laparoscopic tubal ligation arm). The initial sample size relied on enrolling patients who were newly implanted with Essure until May 2020.
"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 said.
The E-Sisters are not so sure about that though.
"We knew that Bayer meeting the enrollment requirement was going to be a significant issue as awareness about the dangers of the Essure device is everywhere now, especially since the Netflix release of The Bleeding Edge," the patient advocacy group said Wednesday in response to the new study requirements. "While we agree with the FDA in taking steps to lengthen the time frame from three to five years and ordering more specific blood tests to look at autoimmunity, the fact of the matter is that Bayer is still running the show and has a vested interest in providing favorable results."
The Essure Problems group is particularly concerned about the significant drop in enrollment numbers of Essure patients under the revised protocol.
"So, yet again, the sample size of women implanted with Essure in this study will be small. We do not understand why the FDA continues to bend over backward for industry while women continue to be implanted and potentially harmed without holding Bayer accountable. They have the authority to order all Essure kits off the shelves while women that have already been implanted are independently evaluated and studied, yet refuse to do so."Gottlieb said he has heard these women's concerns, however, and is taking the matter seriously.
"I personally had the opportunity to meet with women who have been adversely affected by Essure to listen and learn about their concerns. Some of the women I spoke with developed significant medical problems that they ascribe to their use of the product. We remain committed to these women and to improving how we monitor the safety of medical devices, including those related to women’s health."