FBI Investigates Power Morcellators
The Federal Bureau of Investigation is currently investigating whether device manufactures failed to meet federal requirements when reporting adverse events to the Food and Drug Administration (FDA).
Power Morcellators Can Spread and Worsen Cancer
Power morcellation is used to cut up tissue into small pieces in order to remove it from tiny incisions during laparoscopic and robotic surgeries for removing uterine fibroids or for performing hysterectomies, according to the New York Times.
The Washington Post reports that the FDA has found and warned that 1 in 350 women undergoing power morcellation for hysterectomy or fibroid removal will have an undetected uterine sarcoma, an aggressive type of cancer. The New York Times reports that recent studies have found a similar risk of undetected cancer in women undergoing uterine power morcellation.
An article published in the journal PLOS One found that this rate is at least nine times higher than women were being told prior to undergoing the power morcellation procedure. These undetected cancers are impossible to identify prior to the procedure and that the spinning blades of the power morcellator can spread the cancerous tissue throughout the abdomen, according to the USA Today.
Studies have found that when the cancer is spread in this manner, it increases the rate of the cancer spreading and worsens disease free survival and overall survival.
FDA Has Added Black Box Warning to Power Morcellators
In April 2014 the FDA issued a warning discouraging medical providers from performing power morcellation in procedures to remove fibroids or during hysterectomies, according to the New York Times.
Mass Device reports that in November 2014, the FDA added a black box warning to the label of power morcellators warning against use in most patients. WebMD reports that the boxed warning will include:
- Warning for doctors and patients that uterine tissue can contain hidden cancer and that power morcellators can spread the cancer and decrease long-term survival
- Warning that power morcellators should not be used in patients who are at or around menopause or who are having a hysterectomy due to fibroids
- Warning that power morcellators should not be used in gynecologic surgery in which tissue is known or suspected to be cancerous
The Wall Street Journal reports that a boxed warning is the strongest warning issued by the FDA before removing a drug or device from market and that it is unusual for black box warning to be placed on a medical device.
The Wall Street Journal also reports that Johnson and Johnson, the largest power morcellator manufacturer through its Ethicon unit, has pulled its power morcellators from the market and that hospitals and health insurers are not providing or covering the procedure.
FBI Investigating Power Morcellators
The New York Times is reporting that the FBI is investigating power morcellator manufacturers and medical providers to determine if any laws were broken.
Failing to report an adverse event associated with a medical device is against the law and the FBI is investigating if cases of power morcellators spreading and worsening cancer were reported to the FDA, according to Medscape.
CBS News reports that the FBI is investigating Johnson and Johnson to determine what the company knew about the risks of its Ethicon power morcellators spreading cancer prior to their removal from the market in the second half of 2014.
Part of the FBI investigation included interviewing a pathologist who wrote to Johnson and Johnson in 2006 warning of the risk of the Ethicon power morcellators spreading cancer, according to the Wall Street Journal.