News organizations report that the Federal Bureau of Investigation (FBI) is looking into whether medical device makers, doctors, and hospitals broke the law by failing to report problems with a surgical tool used in hysterectomies and fibroid surgery.
The Wall Street Journal first reported the investigation last week. Though the FBI will not confirm the investigation, people involved say they were interviewed by agents working out of the FBI office in Newark, N.J., the New York Times reports.
The tool under investigation—the power morcellator—uses rapidly spinning blades to cut uterine tissue into small pieces that can be removed from the body through the tiny incisions. Morcellators are used in hysterectomies (removal of the uterus) and in fibroid surgery, but in women with undetected cancers the morcellator has sprayed malignant cells inside the abdomen, speeding the progression of the disease.
Dr. Hooman Noorchashm, whose wife, Dr. Amy Reed, experienced the spread of cancer after a hysterectomy with a morcellator, told the Times they had spoken to an FBI agent from Newark. Retired Pennsylvania pathologist, Dr. Robert W. Lamparter, has also spoken to FBI agents.
Dr. Reed, an anesthesiologist, had a hysterectomy because of fibroid tumors in Boston in 2013. Fibroids themselves are benign but they sometimes hide cancerous tumors. A biopsy after Reed’s surgery revealed uterine sarcoma, an aggressive type of cancer. The tumor spread, resulting in advanced Stage 4 cancer. Dr. Reed underwent rounds of chemotherapy and additional surgery but the cancer recurred this past March, near her spine, and she underwent more surgery.
Noorchashm and Reed have led a nationwide campaign to ban morcellators. But some gynecology groups resist a ban, saying that sarcomas are uncommon and the morcellator allows for less invasive and safer surgery for the majority of women. The FDA estimates that there is a one in 350 chance that a woman has an undetected sarcoma. In November, the Food and Drug Administration (FDA) said morcellators should no longer be used in “the vast majority” of” of women, but the agency stopped short of banning morcellators altogether. Johnson & Johnson withdrew its morcellators from the market in July, the Times reports, and some insurers no longer cover routine use of the tool.
Dr. Noorchashm contacted the FBI last fall because he said he suspected that morcellator manufacturers, doctors and hospitals were violating federal law by not reporting adverse events involving morcellators to the FDA. Dr. Lamparter said he recently spoke to the FBI about his 2006 correspondence with Johnson & Johnson’s Ethicon division, the unit that sold power morcellators. He warned of the risk of spreading undetected cancer. He has provided the email correspondence to the Times and other news organizations.
In response to Lamparter’s warnings, Johnson & Johnson said it added new language to the instructions for morcellator use. J & J said it already recommended that the surgeon use a special bag to remove uterine tissue where a sarcoma was suspected. Despite these cautions, Dr. Lamparter said he believes that “the morcellator, as it is used now, is just a bad idea.”