Safety reports related to Bayer's Essure birth control device have been piling up at the FDA and now, the agency is making its move. It issued an order restricting the sale and distribution of Essure to healthcare providers and facilities that provide information to patients about the risks and benefits of the device.
The FDA had ordered Bayer to conduct a postmarket study and add a boxed warning and patient decision checklist to the device's labeling in February 2016. But while the agency reckons that Essure sales have dropped about 70% since those changes were made, "some women still are not receiving information about the known risks of Essure before implantation," it said in a statement.
Now, the agency is using a "unique type of restriction" to make sure only providers and facilities that inform patients about the risks and benefits of the device may offer it. The new labeling requires providers to review a brochure with a prospective Essure patient. It has an acknowledgement that both the patient and the implanting physician must sign.
As the manufacturer, Bayer must ensure that providers comply with the new restrictions, the FDA said. If it doesn't, the agency will "take appropriate action," which includes criminal and civil penalties.
“We’ve been closely evaluating new information on the use of Essure, and based on our review of a growing body of evidence, we believe this product requires additional, meaningful safeguards to ensure women are able to make informed decisions about risk when considering this option,” said FDA Commissioner Scott Gottlieb, M.D., in the FDA statement. “We take the concerns of all women affected by Essure very seriously. I’ve personally had the opportunity to meet with several women and hear their important concerns about this product. Despite previous efforts to alert women to the potential complications of Essure, we know that some patients still aren’t receiving this important information. That is simply unacceptable. Every single woman receiving this device should fully understand the associated risks.”
Initially approved in 2002, Essure is the only permanent birth control device that is implanted without a surgical incision. It comprises two metal coils that are inserted through the vagina and cervix into the fallopian tubes. Over three months, scar tissue builds up around the coils, eventually creating a barrier that stops sperm from reaching the eggs.
The company has been hit with a number of lawsuits from plaintiffs complaining of various problems and injuries from the device. These include perforation of the uterus and/or fallopian tubes, migration of inserts to the abdominal or pelvic cavity and persistent pain, among others. Bayer announced in September that it would stop selling Essure outside the U.S., but said it was for commercial, rather than safety, reasons.