The Federal Bureau of Investigations has launched an investigation into whether major devicemakers and their customers routinely broke the law by failing to report adverse events related to uterine morcellation, a cardiac surgeon interviewed by bureau agents says.
Dr. Hooman Noorchashm of Philadelphia told IDDM that he approached the FBI with his concerns after his wife’s cancer spread throughout her body following a morcellation procedure at Boston’s Brigham & Women’s Hospital in 2013. The couple finally got a response from the bureau’s Newark, N.J., district office earlier this year, with agents interviewing Noorchashm, his wife and several other patients and physicians.
Power morcellators, which are used to remove uterine fibroids, came under scrutiny in April 2014 when the FDA issued a safety alert saying the devices’ blades could spread cancerous tissue throughout the abdomen. At least 21 cases of cancer attributed to morcellation were known to the FDA as of a summer advisory panel hearing, with the suspicion being that many more had gone unreported.
After retired pathologist Dr. Robert Lamparter warned morcellator maker Johnson & Johnson that he believed the devices could spread malignancies because of the number of unsuspected uterine cancers at his small hospital, J&J edited the packaging of Morcellex to specifically warn of the risk of disseminating malignant tissue, J&J spokesman Matthew Johnson told IDDM.
The packaging suggests that physicians who suspect cancer use a special tissue extraction bag during morcellation procedures.
But Noorchashm says manufacturers and healthcare facilities failed to alert the FDA or take other steps to protect patients from morcellation’s dangers, even as they knew of the risks.
“The bottom line is that a specific federal law has been violated, and a lot of people have been harmed or died,” he says. “I think the FBI and Congress will take an interest in how something like that could happen.”
Specifically, Noorchashm said hospitals and devicemakers violated the medical device reporting regulation (21 CFR 803) by failing to report cancer risks even though morcellators have been used for 20 years.
The FDA required a black box warning on the devices in December 2014 and recommends against their use for most women, but has not requested the devices be removed from the market.
Johnson says J&J hasn’t been contacted by the FBI, and he doesn’t believe the firm or its Ethicon subsidiary are being targeted specifically in what might be a broader survey of the industry.
The FBI won’t confirm investigations until charges are filed. — Elizabeth Orr