Federal investigators are reportedly conducting a probe of medical devices that have been linked to the spread of uterine cancer.
The Wall Street Journal reports that the FBI is investigating what Johnson & Johnson, at one time the largest manufacturer of laparoscopic power morcellators, knew about the dangers associated with their use before pulling them from the market in 2014.
A spokesman for the FBI's Newark, N.J., office declined to comment Wednesday afternoon, and would neither confirm nor deny the existence of an investigation.
A Johnson & Johnson spokesman said the company has not been contacted by the FBI regarding an investigation and had no knowledge of any probe.
Until a few years ago, power morcellators were commonly used to cut up and laparoscopically remove fibroids formed in the uterus. Last April, the Food and Drug Administration issued a safety communication that warned the devices should not be used in women undergoing hysterectomy or myomectomy procedures because they could spread previously undetected uterine sarcoma tissue, which the agency estimated were found in 1 in 350 cases.
Morcellator use for such procedures has gone down steadily among healthcare providers since reports of their adverse effects.
“If laparoscopic power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient's likelihood of long-term survival,” the agency warned. “For this reason, and because there is no reliable method for predicting whether a woman with fibroids may have a uterine sarcoma, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids.”
The agency updated its guidance on power morcellators last November, specifically warning that the use of such devices for laparoscopic uterine procedures carried the risk of spreading cancer.
The Wall Street Journal reported that it was unclear about the current stage of the investigation, and whether the probe is specifically targeting Johnson & Johnson or any other makers of morcellators.
