The Wall Street Journal reported on May 27, 2015 that the FBI is investigating whether Johnson & Johnson, the largest maker of a morcellator surgical tool found to spread uterine cancer, knew about the hazards.
People who have been interviewed by the FBI regarding the morcellator said the agency is investigating what Johnson & Johnson knew about the morcellator’s hazards before pulling it from the market last year.
The FBI’s Newark, N.J. office is overseeing the investigation, according to WSJ, but reports said J & J isn’t aware of an investigation involving the laparoscopic power morcellator.
According to those questioned, FBI agents have recently interviewed several people: a retired pathologist who alerted J&J about morcellator problems in 2006; a doctor who said a morcellator worsened her own cancer in 2013; a California woman who has collected names of some 400 patients and families of patients who may have been harmed by the tool.
In Nov. 2014, the FDA warned morcellators shouldn’t be used on most women. Many hospitals and the nation’s largest health plans have since limited morcellator use or are considering limits. The FDA then called for a “black-box” warning – its strongest red flag – on the morcellator.
Morcellators were used in tens of thousands of procedures a year. They slice benign uterine growths known as fibroids so the tissue can be removed through tiny incisions, usually for hysterectomies.
In April 2014, the FDA warned that women undergoing fibroid surgery have a 1 in 350 chance of having dangerous uterine sarcoma that can’t be reliably detected before the operation. FDA said morcellators can spread malignancy and worsen outcomes.
Morcellators pulled by Johnson & Johnson
J&J withdrew morcellators from the market in July 2014, but other morcellator makers’ devices remain on the market.
A former pathologist at Evangelical Community Hospital in Lewisburg, Pa., Robert Lamparter said the FBI questioned him on May 12 about his 2006 correspondence with J&J subsidiary Ethicon.
According to the Wall Street Journal, Dr. Lamparter contacted Ethicon after he began noticing more morcellated specimens in his lab. Lamparter wrote that he was concerned about several issues, including the potential for an undetected cancer to be inadvertently spread by the surgical instrument.
In a Feb. 2006 email that Dr. Lamparter wrote to David Robinson, then an Ethicon medical director, that even at his small hospital, which he said had done 292 hysterectomies the previous year, gynecologists found an unexpected malignancy at least once annually.
Morcellator jeopardizes Patient Survival
“If a morcellation is done, the patient’s survival is jeopardized,” Dr. Lamparter wrote.
J&J spokesman Matthew Johnson confirmed the 2006 correspondence with Dr. Lamparter and said the doctor’s concerns led the company to revise the IFU – Instructions for Use.
The new language included a caution line regarding the presence of cancer, that the morcellator “may lead to dissemination of malignant tissue,” Dr. Robinson wrote Dr. Lamparter in April 2006.
J & J’s instructions had already recommended that doctors who suspect or know of malignant tissue should use a “tissue extraction bag”– used to pull tissue from the body – with the device.
WSJ said Dr. Robinson since retired from Ethicon and couldn’t be reached for comment.
Johnson also told WSJ that Ethicon morcellators “have always included cautions in their instructions for use about the potential spread of malignant (or suspected malignant) tissue.”
Physician Assistant contacted by FBI
WSJ also reported that a physician assistant in Los Altos, Calif., Sarah Robinson, said she was contacted by the FBI about two months ago. Ms. Robinson testified at an FDA hearing on the morcellator. She has collected a list of women and families of women who believe their cancer was worsened by it. Ms. Robinson said she sent an FBI agent a list of 386 women’s names on April 3, 2014.
WSJ reports that it appears, “[I]n the case of power morcellators, this device’s capacity for upstaging women’s deadly cancers was not reported to FDA for over 20 years – until a small group of affected citizens did so.”
That is a very strong admonition from a staunchly pro-business publication. Morcellators have some problems.