Company Fails To Report A Problem With A Surgical Tool?. The Federal Bureau of Investigation (FBI) is looking into whether medical device makers, and some doctors and hospitals, broke the law by failing to report problems with a surgical tool used during gynecologic surgery.
News of the investigation comes from people who said they were interviewed by FBI agents, the New York Times reports.
The tool—the power morcellator—has rapidly spinning blades that cut uterine tissue into small pieces that can be removed from the body through the tiny incisions. Morcellators have often been used in hysterectomies (removal of the uterus), but in women with undetected cancers the morcellator has sprayed malignant cells inside the abdomen, speeding the progression of the disease.
The Wall Street Journal first reported the investigation last week and said the agents involved worked out of the FBI offices in Newark, N.J. A spokesperson for the Newark office would not confirm the investigation.
Dr. Hooman Noorchashm, whose wife, Dr. Amy Reed, was harmed by the device, confirmed to the Times that they had spoken to an FBI agent from Newark. And retired pathologist, Dr. Robert W. Lamparter, also said he had spoken to investigators. Both men said they had been warned about disclosing too much information, which they were told could interfere with the investigation.
Numerous rounds of chemotherapy and additional surgery
Dr. Reed, who is an anesthesiologist, had a hysterectomy because of fibroid tumors at Brigham and Women’s Hospital in Boston in 2013. Fibroids are benign, but they sometimes hide cancer. After Dr. Reed’s surgery, a biopsy revealed a hidden sarcoma, an aggressive type of cancer. The tumor spread, resulting in advanced Stage 4 cancer. Dr. Reed underwent numerous rounds of chemotherapy and additional surgery. The cancer recurred in March of this year, near her spine, and she underwent more surgery.
Noorchashm and Reed have conducted a nationwide campaign to ban morcellators. But some gynecology groups say that sarcomas are uncommon and morcellation makes surgery less invasive and safer for the majority of women. The FDA estimates that a woman undergoing a procedure with a morcellator has a one in 350 chance of having a hidden sarcoma.
Last 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 taking morcellators off the market or banning their use. Johnson & Johnson withdrew its morcellators from the market in July, the Times reports.
Dr. Noorchashm said he contacted the FBI last fall because he suspected that morcellator manufacturers, doctors and hospitals had violated federal law by not reporting adverse events to the FDA.
Dr. Lamparter recently spoke to the FBI about his 2006 correspondence with Johnson & Johnson’s Ethicon division, the unit that sold power morcellators. At that time, he warned of the risk of the morcellators spreading undetected cancer.
He has provided emails to the Times and other news outlets. Johnson & Johnson has said that in response to the concerns Dr. Lamparter raised, it added new language to the instructions for use of the device. J & J said they already recommended that where a sarcoma was suspected, the doctor should use a special bag to remove the tissue. Dr. Lamparter said he has come to believe that “the morcellator, as it is used now, is just a bad idea.”
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