Defective Medical Devices to have Increased Transparency due to Proposed Government BillAug 12, 2016
In 2014, the U.S Food and Drug Administration (FDA) issued a safety alert regarding the power morcellator. This device used for laparoscopic uterine surgery for women has been linked to spreading cancer, causing the FDA to discourage use of the device. The devices were not recalled off the market, although morcellator manufacturers Johnson & Johnson (J&J) voluntarily recalled the device when reports began to emerge linking morcellators to ovarian cancer.
Now, a group of patient advocates led by a husband-and-wife team, both physicians, are lobbying to encourage the FDA to get the allegedly dangerous devices off the market, altogether. U.S. Representative Louise Slaughter and Michael Fitzpatrick have teamed up with other physicians for the introduction of the Medical Device Guardians Act of 2016, reports The Cincinnati Enquirer of June 10, 2016. If successful, the legislation would permit doctors, surgeons, and other health care professionals the ability to report problems with medical devices to the FDA. Previously, they had the power to report issues with pharmaceuticals, but not medical devices.
A morcellator is minimally invasive and lessens the recovery time for the patient as well as lessening the time spent in the hospital. However, it is alleged that dormant cancerous cells contained within fibroids may be spread throughout the uterus during laparoscopic uterine surgery, triggering ovarian cancer. Surgical bags may be employed to contain the fragments within the uterus to help minimize the spread of potentially cancerous cells.
The division of J&J, Ethicon, responsible for power morcellators, responded by withdrawing the device from the market completely in July, 2014, after suspending all sales initially of the device the previous April. The FDA has decided that power morcellators can remain on the market pending further scrutiny, leaving it up to doctors and their patients to decide whether to use invasive surgery or take a chance for spreading cancer using the power morcellator.