US lawmakers introduce bills to extend oversight of medical devices
11 Jun 2016
Lawmakers in Washington on Wednesday introduced legislation that sought better protection of patients from faulty medical devices.
The birth control device, Essure, had earlier been blamed by several Colorado women for chronic pain and other problems. It was expected that the bills introduced this week would strengthen the FDA's review process of devices like Essure, and constitute a step in the right direction.
''We want justice for the women who have been harmed by Essure and their children who have been harmed by Essure. We want justice for everyone who has been harmed by a medical device that was approved under questionable circumstances,'' said a victim's advocate, denver.cbslocal.com reported.
Representative Louise Slaughter, a New York Democrat, had sponsored the bills along with Representative Mike Fitzpatrick, a Pennsylvania Republican.
''Every once in a while there's a medical device that gets approved through either a fast track approval or a more rigorous approval that may do more harm than good,'' Fitzpatrick said.
The legislation would allow for companies to be held accountable if their device malfunctioned or had not been properly tested.
The two bipartisan bills would make it easier for patients victimised by faulty devices to sue the manufacturers and also require physicians to tell the FDA about any problems the devices caused patients.
Under the Medical Device Guardians Act of 2016 doctors would be required to report problems caused by devices such as power morcellators, which had been routinely used in minimally-invasive fibroid surgery, to the Food and Drug Administration.
Morcellators are tools that have high-speed blades to cut tissue and make it easier to remove through small incisions. According to the bill's sponsors, problems with morcellators, including those once made by Blue Ash-based Ethicon, directly led to their proposal.
Under the current law, only hospitals and manufacturers were required to communicate such information to the FDA, which, according to patient advocates led to serious under-reporting.
Physicians are already required to communicate the adverse effects of prescription drugs to the FDA, using an online database.
