January 26, 2015 — The leader of a campaign to ban power morcellators because they can spread cancer has published a scathing critique of the FDA’s 510(k) approval process and failures of medical device safety legislation.
Philly.com published an editorial written by Dr. Amy Reed, a woman who was diagnosed with stage-4 leiomyosarcoma, and her husband, Dr. Hooman Noorchashm.
Dr. Reed and her husband launched a public awareness campaign about the cancer risks associated with morcellators in late 2013. It soon caught the attention of the FDA, which launched its own investigation. The FDA added a “Black Box” warning to the label on morcellators in late 2014.
Dr. Reed questioned whether lobbyists from the medical device industry have jeopardized public safety by enticing congressional representatives to craft legislation that prioritizes approval of new devices rather than public safety.
She specifically cites the FDA’s 510(k) loophole, which allows new devices on the market without requiring new safety studies so long as the device is “substantially equivalent” to another device that has already been approved.
In recent years, over 100,000 lawsuits have been filed by people who were injured by defective medical devices approved with 510(k) applications, such as vaginal mesh and metal-on-metal hip implants.
Lawsuits involving uterine cancer caused by morcellators could be the next big litigation. Dr. Reed warns:
“Because these women were harmed by ‘life-saving devices; bearing a seal of FDA authorization – and because their cancers were spread by our own doctors using an unsafe practice that is claimed to “benefit the majority” – our federal government and its agency stands lethargic and ambivalent.”
Do I have a Morcellator Lawsuit?
The Schmidt Firm, PLLC is currently accepting power morcellator induced injury cases in all 50 states. If you or somebody you know has been diagnosed with uterine cancer, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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