The Food and Drug Administration (FDA) announced on April 16th, 2019 that they are halting and banning the sale of all pelvic mesh devices over safety concerns.
Safety Not Assured
According to an article by CNN a statement was released by the FDA that highlighted the fact that the administration “has determined that the manufacturers Boston Scientific and Coloplast have not demonstrated a reasonable assurance of safety and effectiveness for these devices.”
These devices were originally created to help with a condition known as pelvic organ prolapse, where weakened muscles in the pelvic area cause the pelvic organs to drop creating a bulge. It was in the early 2000’s where the first pelvic mesh product was created to treat this issue.
Overhauling Medical Device Testing
In late November 2018 the FDA announced it would be reworking its medical device testing process (read more about the changes here). The announced change came on the heels of a massive report released to the public worked on by journalists all across the globe. The journalists looked into the medical device process and found massive amounts of injuries, corruption, and fraud (view the report here).
Injured by a Pelvic Mesh product?
If you or a loved one has been injured by a pelvic mesh product please contact our office at tel:(303) 327-9988 to schedule a free consultation and speak with one of our attorneys. Please also visit our practice area page on personal injury here for more information.