Posted in News on June 5, 2015
Montana residents should be interested to know that, according to some doctors, the FDA may not be doing enough to recall and remove a medical device in use at hospitals which may be putting cancer patients’ lives in danger.
According to media reports, in 2013 doctors became aware of a 42-year-old doctor’s cancer while they were operating on her in an effort to remove uterine fibroid tumors. In order to remove the tumors they employed a device called a power morcellator that shreds the fibroid tissue making it easy for the surgeons to then extract the shredded cancerous tissue via a small incision thus limiting the possibility of living with permanent scars.
In this particular instance when the surgeons used the morcellator they ended up actually spreading the cancer rather than removing it. To combat the spreading cancer the 42-year-old had to undergo multiple additional surgeries as well as additional rounds of chemo therapy.
One of the device manufacturers had removed its device from the market the previous year in response to a safety communication that was issued by the FDA. In the safety communication the FDA informed surgeons about the risk of spreading tumor growth when using the device. The FDA however stopped short of issuing a recall for the medical device citing that the device was medically viable in certain limited medical cases.
According to news sources the FBI has launched an investigation to ascertain what the company knew about the risks inherent in the use of the device. Problems were brought to the company’s attention as early as 2006 and yet the company chose to not address the problem.
Source: KTVQ, “Doctor with cancer raises alarm about medical device,” May 31, 2015