RICHMOND, Va. (WRIC) — A new study seems to confirm what 8News uncovered months ago — the FDA may have used faulty data to approve the birth control device Essure.
This new study out of Northwestern University looked at OB-GYN medical devices approved by the FDA over the past 15 years. It found many devices, including Essure, went to market based on flawed data.
The study looked at 18 devices, mostly for contraception or reducing menstrual flow, and found 22 percent were green-lighted by the FDA even though they failed to show effectiveness in clinical trials.
The study also found the nickel coil device Essure was approved based on short-term evidence and insufficient post-market follow-up, something echoed by other researchers in an 8News investigation last year.
The FDA tells 8News as policy the agency doesn’t comment on individual studies but considers them in terms of how they evaluate safety.
The study comes as lawmakers in Washington plan Wednesday to introduce legislation to strengthen the FDA’s medical device review process. 8News will keep you posted on that.