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 statementissued 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…