The U.S. Food and Drug Administration released its final guidelines on the controversial Essure Permanent Birth Control System, and women injured by the device say the agency failed them.
“The guidance includes a ‘suggested’ black-box warning along with a patient decision checklist,” the support group Essure Problems — a Facebook group with more than 30,000 members — said in a statement. “Once again, we find that the FDA has done a pitifully insufficient job.”
The Essure Birth Control System hit the market in 2006.
