FDA restricts sale of Essure birth control after thousands of complaints

The Food & Drug Administration issued an order Monday restricting the sale and distribution of a brand of permanent birth control after years of receiving complaints about its side effects. 

Essure, manufactured by Bayer, will now only be sold to health-care facilities that provide full information about the device’s risks and benefits, the FDA said. 

{mosads}Essure is the only permanently implanted birth control device on the market that doesn’t require a surgical incision.

The birth control was approved in 2002, but given the strongest safety warning label in 2016 following thousands of complaints from women who said it caused pelvic pain, hair loss, muscle weakness, perforation of the uterus and other issues. 

The FDA last month said it received nearly 12,000 medical reports in 2017 related to Essure.  

Bayer could face civil or criminal penalties if it doesn’t comply with the new rules. 

“We take the concerns of all women affected by Essure very seriously,” FDA Commissioner Scott Gottlieb said in a statement Monday. 

“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.”

Patient advocacy groups and lawmakers have called for the FDA to remove the device from the market. 

The company is facing more than 10,000 lawsuits in the U.S.