The Food and Drug Administration (FDA) has conducted investigations of several hospitals to find out why doctors and administrators did not report patient injuries and deaths caused by complications for gynecological procedures using power morcellator devices.
Under the Code of Federal Regulations, manufacturers of medical devices and hospitals are required to report to the FDA within 10 to 30 days adverse outcomes such as serious injuries and deaths that a medical device may have caused or contributed to. But in the case of power morcellators, this required reporting system appears to have failed.
Power morcellators are surgical tools that shred uterine growths or entire uteruses inside the body and removes the tissue through small incisions. The devices have been blamed for spreading undetected uterine cancer, worsening the odds of survival. Essentially, the device can turn a Stage 1 cancer immediately into a Stage 4 cancer.
The FDA says it never received a report of adverse outcomes from manufacturers of power morcellators until December 2013.
But, according to The Cancer Letter, which has followed the power morcellation saga since 2014, the device was first linked to cancer spread in 2012, following the hysterectomy of patient Erica Kaitz at Brigham & Woman’s Hospital. The patient died in December 2013.
In October 2013, Amy Reed, another patient who underwent the same procedure at the same hospital, was diagnosed with uterine sarcoma. She went on to lead a campaign against widespread use of power morcellation, which resulted in the FDA placing a black box warning on the device.
In 2012, two Brigham doctors published a study in which four out of 1,091 patients who underwent power morcellation were diagnosed with advanced leiomyosarcoma, or uterine cancer.
Johnson & Johnson, whose subsidiary Ethicon was the largest manufacturer of the device, said it was not aware of the risk of cancer spread prior to December 2013. However, a retired pathologist from Pennsylvania claims he reported to Johnson & Johnson in 2006 his concerns that power morcellators could be worsening undetected uterine cancer in some women.
One congressman is working to push meaningful reforms to make medical devices safer for the public. Rep. Mike Fitzpatrick (R-PA), in a letter to Vice President Joe Biden applauding the administration’s efforts to fight cancer with the Cancer Moonshot, wrote, “As part of the Cancer Moonshot, we have the chance to protect others from the harm caused by dangerous medical devices. In 2016 there will be an estimated 595,690 cancer deaths in the United States. We must guard against unsafe medical devices from contributing to those staggering statistics. 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.”
Source: The Cancer Letter