On September 24, 2015, the FDA met to discuss the risks of Essure after receiving nearly 5,000 adverse reports on the birth control device. The risks included abdominal pain, puncturing of the uterus, device migration, nickel allergy, and other injuries.
On February 29, 2016, the FDA required a new clinical study for Essure to determine the safety risks. Additionally, the FDA recommended labeling changes including a boxed warning label and checklist for doctors to discuss potential risks from Essure.
If you or a loved one suffered tubal/uterus puncturing, bleeding, or other injuries from Essure, please call our experienced products liability attorneys at (888) 606-5297 for a free consultation about your Essure lawsuit.