Is the FDA doing enough to protect patients from potentially dangerous medical devices? Two Philadelphia area doctors say no. They're fighting to prevent more tragedies, while living through their own medical nightmare.
42-year-old Dr. Amy Reed and her husband, Dr. Hooman Noorchashm, have been fighting their battle since Reed was diagnosed with cancer in 2013. CBS Philly's Stephanie Stahl has been following their story for a year.
Reed's cancer was found after an operation to remove uterine fibroid tumors. Surgeons used a device called a power morcellator to shred the fibroid tissue so it could be easily removed through a small incision. But the shredding ended up inadvertently spreading cancer that hadn't been detected.
One of the device makers, Johnson & Johnson, pulled its morcellators off the market last year after the FDA issued a safety communication warning doctors about the risk. The FDA did not order a recall, saying the device could be appropriate for a small number of women.
Reed and Noorchashm say more should have been done to protect patients, and they have spoken with FBI investigators about their concerns.
"This is a violation of federal law that has led to the loss of life, so I think that is what got the FBI's attention," Noorchashm told CBS Philly.
Earlier this week, the Wall Street Journal reported that the FBI is looking into what Johnson & Johnson knew about the device's risks. Problems were reportedly first brought to the company's attention in 2006.
Reed says if action had been taken earlier, her situation might have been prevented -- "not only mine but hundreds of other women. That's what's so maddening."
Since her diagnosis, Reed has been through multiple surgeries and rounds of radiation and chemotherapy. She recently had a recurrence, a tumor in her spine.
When asked what she tells her six children, she replied, "Having kids forces you to be very forthcoming. You say 'cancer' and they say 'well, will it kill you?' And you say 'I don't know.'"