January 26, 2015 — Philly.com has published an editorial critiquing the failures of medical device safety legislation written by Dr. Amy Reed, a woman who was diagnosed with cancer after being treated with a power morcellator.
After a hysterectomy in which a morcellator was used to grind up uterine tissue, Dr. Reed was diagnosed with stage-4 leiomyosarcoma.
While fighting the disease, Dr. Reed and her husband, Dr. Hooman Noorchashm, have been leading a campaign to raise awareness about the cancer risks associated with morcellators.
In recent years, the FDA has come under scrutiny for approving a number of devices under the 510(k) loophole, which allows manufacturers of new devices to avoid conducting rigorous, expensive safety studies so long as the device is “substantially equivalent” to another device on the market.
Over 100,000 lawsuits have been filed by people who were injured by vaginal mesh and metal-on-metal hip implants, for example, which were both approved with 510(k) applications.
Dr. Reed blames the problem on the medical device industry lobbying congressional representatives to focus legislation on bringing new devices to the marketplace quickly. She warns that this approach jeopardizes patient safety.
According to Dr. Reed and Dr. Noorchashm:
“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.”
Even when safety risks are identified, it often takes the FDA months or even years to act. Laparoscopic power morcellators have been on the market since the 1990s, but cancer risks were not investigated until 2013 and a “Black Box” warning was not added to the label until late 2014.
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