Fitzpatrick Statement on Release of FDA’s Essure Review
Congressman Mike Fitzpatrick (PA-8) released the following statement Monday regarding the announcement of the Food and Drug Administration’s five-month review of the permanent sterilization device Essure:
“It’s unbelievable that it took the FDA since September to make just two recommendations with no enforcement measures and ask the manufacturer to perform another study while leaving Essure on the market.
Frankly, I’d contend that the 25,000 women harmed by Essure are the postmarket study that FDA is ordering. It’s been done. The evidence is all there: Tens of thousands of injured women and hundreds of fetal deaths. As my constituent, Dr. Amy Reed, a victim of unsafe devices herself, testified at the FDA in September, ‘[w]e don’t need to hurt any more women.’ If the FDA is going to order another study, then at minimum they should take Essure off the market during that time. A 60 day comment period and another study while this device remains on that market only guarantees more women harmed.
Because the FDA is failing to act, I believe Congress must. That’s why, moving forward, I will advocate for a number of legislative actions to address this issue, including:
- Continuing my call for the House and Senate to take up and pass the E-Free Act to revoke the FDA approval of Essure;
- Working to block government agencies — such as the DOD and VA — from purchasing this unsafe device; and
- Introducing new legislation to eliminate the blanket civil liability protections that device manufacturers like Bayer currently receive for a non-life-saving device like Essure because those harmed deserve a voice in court.
Simply put, it’s time for Congress and the FDA to get serious about reforming medical device safety laws.”
Fitzpatrick has been the leading voice in Congress calling for removal of Essure from the market — introducing the E-Free Act in November of 2015. Ahead of the FDA’s report, Fitzpatrick wrote to the agency urging them to consider possible inconsistencies in the number of fetal deaths caused by the device and also legal complaints alleging illegal kickbacks.
More than 25,000 women reported symptoms including extreme pelvic and abdominal pain, migraines, loss of teeth and hair, and the coil cutting into the uterus and other organs in the abdominal cavity. 10,000 have filed formal complaints with the FDA.