Rep. Mike Fitzpatrick (R-PA), in a letter to Vice President Joe Biden, applauded the efforts of the Obama Administration’s Cancer Moonshot program to make cancer “a thing of the past” and developing a virtual Center of Excellence within the Food and Drug Administration (FDA). But the Congressman stressed that while it is critically important to support the development of innovative new devices and drugs to treat cancer, it is just as critical to implement meaningful reforms to make medical devices safe.
“Unfortunately, for decades, a medical device known as a laparoscopic power morcellator proved tragically unsafe, spread cancer throughout the body of those it was designed to help, and led to the death of hundreds, if not thousands, of women,” Rep. Fitzpatrick wrote.
Power morcellators are medical devices cleared by the FDA to remove uterine fibroids and entire uteruses. The device is fitted with a tube-like blade that shreds the uterine tissue and removes it through a laparoscopic incision. For more than two decades, the surgical tool was marketed as safe for myomectomies (uterine fibroid removal) and hysterectomies.
“However, if a uterine fibroid is harboring an undetectable cancer, the morcellation of that cancerous tissue and its removal through the abdominal cavity can spread that cancer through a woman’s body,” Rep. Fitzpatrick said. “This device can take a Stage 1 treatable cancer immediately to a stage 4 terminal cancer. And tragically for too many women, this routine procedure ended with a death sentence.”
Rep. Fitzpatrick told Biden that the Cancer Moonshot was a chance to protect others from the harm caused by dangerous medical devices. “While supporting the development of new devices to target cancer, we must ensure that the FDA is able to review, monitor and quickly take action should those devices do harm.”
Rep. Fitzpatrick said there are numerous steps that can be taken to improve patient safety. One way is to ensure that serious injuries and deaths caused by medical devices are promptly reported to the FDA. “For years, there was evidence that morcellation was spreading cancer in women. But those reports never made it to the FDA… by the hospitals, the device manufacturers, or the doctors.”
Source: The Cancer Letter