Medical Device Makers, Doctors and Hospitals May Have Violated Federal Law Requiring that Adverse Events be Reported to the FDA

Medical device makers, doctors and hospitals may have broken the law by failing to report problems linked to laparoscopic power morcellators, which are surgical tools used during gynecologic surgery.

The Federal Bureau of Investigation (FBI) is investigating the possibility, headed up by its Newark, New Jersey office. The tool, known as a morcellator, has rapidly spinning blades that cut tissue into pieces so they can be removed through tiny incisions made during minimally invasive surgery. The device is often to remove fibroids, but can worsen or spread undetected cancers by spraying malignant cells throughout the abdomen, like seeds, according to The New York Times (The Times).

The FBI has been interviewing experts as well as individuals who claim to have been injured by a morcellator including Dr. Hooman Noorchashm, whose wife, Dr. Amy Reed, was harmed by the device, and a retired pathologist from Pennsylvania, Dr. Robert W. Lamparter, also said he had spoken to investigators. Dr. Reed, an anesthesiologist, underwent a hysterectomy because of fibroid tumors in her uterus in October 2013 at Brigham and Women’s Hospital in Boston, Massachusetts. The fibroids were benign, but the surgery uncovered a hidden sarcoma, an aggressive form of cancer. The cancer spread, sending Dr. Reed into advanced Stage 4 cancer, The Times reported.

Dr. Reed and Dr. Noorchashm have been campaigning tirelessly around the nation to ban morcellation. Gynecology groups have pushed back, saying that sarcomas are uncommon and that morcellation provides a safer, less invasive surgical experience for the majority of women. The U.S. Food and Drug Administration (FDA) so far has not banned morcellation, but the agency warned in November that the device should no longer be used in “the vast majority” of women,” according to The Times.

Dr. Noorchashm first contacted the FBI’s Newark office last fall on a hunch that morcellator manufacturers, doctors and hospitals had violated federal law requiring that adverse events be reported to the FDA. The doctor told The Times that he and his wife spoke with an agent several times over a few months, and that the FBI seemed increasingly interested, The Times reported.

Dr. Lamparter said his conversations with the FBI mostly focused on his 2006 correspondence with Ethicon, a unit of Johnson & Johnson (J&J), which sold power morcellators. That year, he warned the medical device maker of the potential for the tools to spread undetected cancer, according to email correspondence he provided to The Times and other news outlets. Last July, J&J withdrew its morcellators from the market.

According to Dr. Lamparter, J&J added new language to the instructions for the use of morcellators as a sort of “legal fig leaf.” The company had already recommended that, in patients where a cancer was suspected, doctors should use a special bag to remove the tissue. Dr. Lamparter said the gynecologists at his hospital, Evangelical Community Hospital in Lewisburg, Pennsylvania, reported that the training they received from J&J in using the device did not substantially change after he raised his alarm, The Times wrote.

 

 

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