After a surgical stapler locked up during an appendectomy, the assisting doctor checked out MAUDE – a database that houses medical device failures submitted to the Federal Drug Administration – and found nothing. So, he surveyed leading surgeons and learned that a stapler malfunction had been experienced by more than two-thirds of the doctors. These failures can be deadly.
It turns out the FDA made a special “exemption” to the makers of the surgical stapler that allowed them to keep the malfunction housed within the database hidden from doctors and from public view.
Exemptions Still Occur
Even though the FDA has agreed to be more diligent in device safety, it has continued to create new ways for makers of controversial and risky devices to keep from public view controversial and risky devices.
Pelvic mesh is an example. The FDA issued a “safety communication” in 2011 saying “serious complications” were “not rare.” The device was reclassified with safety studies ordered, causing most makers to remove the device from the market. However, the FDA has since granted pelvic mesh makers a special exemption from reporting injuries to the public.
Read the full Huffington Post article: https://www.huffpost.com/entry/fda-hidden-report-medical-device-covidien-medtronic_b_5c82b680e4b048b2ab56e3d3
More from Tamaki Law
Scores of Sexual Abuse Survivors Come Forward in Response to Santa Fe Archdiocese’s Request for Chapter 11 Bankruptcy Protection.