The Wall Street Journal reports that the Federal Bureau of Investigation (FBI) is investigating the power morcellator, a surgical tool that has been found to spread uterine cancer. The FBI is looking into what Johnson & Johnson, one of the manufacturers of the device, knew about the risks before it pulled its morcellator off the market last summer.
A J&J spokesman said the company is not aware of an investigation, the Wall Street Journal reports that FBI agents have interviewed a retired pathologist who alerted J&J about potential problems with morcellators in 2006; a doctor whose own cancer was worsened by the device; and a California physician assistant who collected the names of nearly 400 patients and families who may have been harmed by surgery using the morcellator.
In November 2014, the Food and Drug Administration (FDA) warned that the morcellator should not be used for the vast majority of women. Since then, many hospitals have either restricted or curtailed the use of the device and some insurers will no longer cover routine use of the morcellator.
The power morcellator is used to remove fibroids, benign uterine growths, and is also used in hysterectomies. The morcellator cuts uterine tissue into small pieces that can be removed through tiny incisions. The device permits a minimally invasive surgical approach, with less blood loss, smaller scars, and a quicker recovery time, the WSJ reports. But if the woman has a uterine sarcoma, an aggressive cancer that cannot reliably be detected before surgery, the morcellator can spread the malignancy in the woman’s abdomen, reducing her long-term chances of survival.
In April 2014 the FDA warned that women undergoing a procedure with a morcellator have a one in 350 chance of having a hidden sarcoma that could be spread by the morcellator. In November, the FDA called for a “black-box” warning on the tool. Johnson & Johnson withdrew the morcellator from the market after the April warning, though other manufacturers continue to sell the device, the WSJ reports.
Dr. Robert Lamparter, a former pathologist at Evangelical Community Hospital in Lewisburg, Pa., said the FBI interviewed him in May about his 2006 correspondence with the Johnson & Johnson’s Ethicon division, the subsidiary that sold morcellators. Dr. Lamparter expressed concern about the potential for undetected cancer to be inadvertently spread by the morcellator. A J & J spokesman said the correspondence with Dr. Lamparter led J & J to revise the instructions for use of the device.
The FBI has also interviewed a Pennsylvania anesthesiologist whose own cancer was worsened cancer after she underwent a hysterectomy with a morcellator in 2013; and Sarah Robinson, a physician assistant in Los Altos, California, who testified at an FDA hearing on the morcellator. Robinson collected a list of women and families of women who believe their cancer became worse after surgery with the morcellator. The Wall Street Journal reports that Robinson sent the list of 386 names to the FBI on April 3.