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A proposal to protect people from unsafe medical devices

In light of the many failures on the part of the Food and Drug Administration (FDA) to adequately protect individuals from unsafe or dangerous medical devices, doctors Amy Reed and Hooman Noorchasm, have proposed a plan to strengthen regulations. Dr. Reed and Dr. Noorchasm have been personally devastated by the FDA's failure to adequately monitor medical devices, specifically the power morcellator.

They discussed their proposal, known as the "Medical Device Guardian Act" in a blog post in Philly.com. Their proposal has three parts.

  • Eliminate conflicts of interest at the FDA. Doctors who rely on a medical device are less likely to be objective about the risks associated with a device.
  • Revise reporting procedures. Per Dr. Reed and Dr. Noorchasm, by prosecuting failures to report and protecting individuals from liability when reporting, individuals are more likely to report these events to proper authorities.
  • Maintain and when necessary, expand the rights of individuals to bring lawsuits against medical device manufacturers for creating dangerous or defective products.

Taken together, these advances should compel medical device manufacturers to emphasize safety in designing and manufacturing their devices. By doing so, fewer people will be injured or killed by adverse outcomes.

Personal tragedy has compelled these doctors to act

In October 2013, Dr. Reed underwent a hysterectomy, in which her physicians used a power morcellator. Power morcellators grind tissue into tiny fragments and can be easily removed from the body cavity. While morcellation promotes faster healing, for women with undiagnosed uterine cancer, morcellation will spread the cancer throughout the abdominal cavity. Tragically, Dr. Reed's cancer spread throughout her body. While she continues to fight cancer, she faces an uphill struggle, as do all women who have suffered upstaged cancer due to power morcellation. The FDA initially denied a link between power morcellation and upstaged cancer. Only after many women died did the FDA issue a "black box" warning on power morcellators.

If you or someone you love has had uterine cancer spread due to power morcellation, or if you have lost a loved one due to this procedure, you have the right to bring a claim for compensation. The attorneys of Fay Law Group, P.A., work with families across the United States. Call 202-522-2715 to set up a free consultation.

Source: Philly.com, Protect patients from medical harm with strong legislation, by Hooman Noorchasm, M.D., Ph.D. and Amy J. Reed, M.D., Ph.D, February 1, 2016

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