Doctors and hospitals failed to tell federal authorities that a medical device used in gynecological procedures could upstage deadly cancer, worsening women’s odds of survival, according to a new report issued by the Government Accountability Office (GAO).
The device in question is called a power morcellator, a surgical tool fitted with a tube-like blade that shreds uterine fibroids or entire uteruses within the uterine cavity and removes the tissue through a small incision in the abdomen. The procedure was preferred for hysterectomies and myomectomies (uterine fibroid removal) over open surgeries because it offers less risk of infection and shorter recovery time.
But doctors have found in recent years that in cases where a woman has undetected uterine cancer, particularly uterine sarcoma, power morcellation can fling bits of cancerous tissue throughout the abdomen and seed new cancer growth, making the disease more difficult to treat.
Patient advocates have pressed Congress and the Food and Drug Administration (FDA) to investigate why the cancer spread risk took so long to be discovered. The devices hit the market in 1991, but the risk of cancer spread was not identified until as late as 2013. The report blames doctors and hospitals for not being more diligent about reporting cases of cancer spread in women who have undergone power morcellation procedures.
But doctors and hospital officials say the blame shouldn’t be on them. Cancer spread as an adverse event related to the device would not have immediately come to mind. FDA admits there is passive reporting of adverse events and that it has been taking steps to establish a better system to evaluate device performance in clinical practice. Some critics of the agency say that one remedy could be the FDA taking a more active role in finding adverse event cases in hospital records as they relate to medical devices.
But mining huge amounts of data for warning signs isn’t cheap. The Trump administration has already indicated that it would like to see drug and device regulations loosened.
Source: New York Times