Just as a new study surfaced out of Northwestern University suggesting that flawed data had been used in the FDA’s approval process for permanent contraceptive device Essure and other gynecological devices for 15 years, lawmakers have proposed legislation to help women affected by complications associated with Essure. The study looked at 18 devices and found that 22% were granted FDA-approval even though they failed to show effectiveness in clinical trials. Specific to Essure, the study also notes that the device was approved based on short-term evidence and insufficient post-market follow-up.
According to the FDA, almost 10,000 women implanted with Essure, a device made of nickel coils implanted into a woman’s fallopian tubes to block sperm from reaching the eggs and therefore preventing pregnancy, have reported severe, painful side-effects from the device—some even leading to death. Now, after hearing their stories, Ariel Grace’s Law was filed in Washington on June 7, 2016 in an effort to hold manufacturer Bayer HealthCare liable for any injuries or deaths related to the use of Essure. The Medical Device Guardians Act, a second bill introduced that day, is aimed at physicians, giving them a better way to report medical device problems they encounter to the FDA.
You may be legally entitled to compensation if you received an Essure implant and experienced adverse side-effects. It’s not too late to investigate your claim. If you or a loved one suffered complications after receiving an Essure implant, please contact us by calling 888-985-7228 for a confidential evaluation of your potential claim.