Following a series of issues related to serious adverse event reports and patient safety issues, Bayer has decided to stop the sale and distribution of its Essure permanent birth control device, effective December 31. Most recently in April, the FDA announced it was restricting the sale and distribution of the device following concerns that women were not being properly informed about the product’s risks prior to implantation.
The serious risks associated with the device include persistent pain, perforation of the uterus and fallopian tubes, and migration of the coils into the pelvis or abdomen, according to the FDA.
“In February, I personally had the opportunity to meet with women who have been adversely affected by Essure to listen and learn about their concerns,” said FDA Commissioner Scott Gottlieb, M.D. in an agency statement. “Some of the women I spoke with developed significant medical problems that they ascribe to their use of the product.”
Although the product will no longer be available by the end of the year, Gottlieb said that the agency expects “Bayer to meet its postmarket obligations concerning this device”.
“I want to stress that, even when Essure is no longer sold, the FDA will remain vigilant in protecting patients who’ve already had this device implanted. We’ll continue to monitor adverse events reported to our database, as well as other data sources. And we’ll communicate publicly on any new findings or concerns.” – Scott Gottlieb, M.D., FDA
Since Essure was first approved, it has been estimated that the device has been implanted in more than 750,000 patients worldwide. In November 2016, Bayer made labeling changes (which included a boxed labeling warning and patient decision checklist) to the device to help better inform patients . Since this action, along with FDA’s requirement that the company conduct a postmarket study, sales of Essure reportedly dropped nearly 70%.