Updated to include response from Bayer.
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.
Bayer responded to the FDA actions, saying that the changes to the post-market trial were the result of a collaborative effort between the company and the federal watchdog.
“The safe and effective use of our medicines and devices is our highest priority, and we are committed to the postmarket study for Essure. Bayer has worked cooperatively with the FDA throughout the implementation of the study and on these study amendments, which provide a measure of flexibility for patient enrollment and allow us to collect additional and valuable long-term data,” Bayer women’s healthcare and neurology U.S. medical affairs VP Dr. Edio Zampaglione said in a press release.
The company also commented on the FDA’s continued review of medical device reports related to the Essure device, suggesting that “the number of these reports represents a small number of the total number of devices sold.”
“It is important to understand that medical device reports are not tracked by name, and it can be very difficult to match one MDR with another. Unless there is absolute certainty that two or more reports are actually the same event, they will be treated as separate events. Given the fact the vast majority of MDRs are non-medically confirmed, this means that there can be and are multiple reports on the same event – such as from the patient, doctor, lawyer, family member or friend – yet they are reported as separate MDRs,” Zampaglione said in a prepared release.
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.
At DeviceTalks Boston, Tyler Shultz will give attendees an inside look at Theranos and how he was able to sound the alarm after he realized the company was falling apart. Shultz will take attendees behind the story that everyone is talking about: the rise and fall of Elizabeth Holmes and her diagnostic company, Theranos.
Join Shultz and 1,000+ medical device professionals at the 8th annual DeviceTalks Boston.