The FBI is reportedly investigating a medical device that was found to spread cancer in women. The device was withdrawn from the market last year, but the Wall Street Journal reports investigators are looking into what Johnson & Johnson, the largest manufacturer of the device, knew about the issue.
Surgeons used the device, known as a laparoscopic power morcellator, during some minimally invasive hysterectomy procedures or in order to remove uterine fibroids. The device was used to grind up tissue so it could be easily removed through a number of tiny incisions. But it was discovered that this method spread cancerous tissue throughout the abdomen and pelvis when it was used on women who had undiagnosed uterine sarcoma cancer, writes CBS News.
Following these revelations, the U.S. Food and Drug Administration issued a warning about the cancer risk in April 2014, saying morcellation could “significantly worsen…the patient’s likelihood of long-term survival.” The FDA then implemented strong warnings on the produce label in November.
Ethicon, a division of Johnson & Johnson, advised doctors to cease use of the devices, before withdrawing them from sale. But models manufactured by other companies are still available on the market.
Prior the withdrawal, about 60,000 of these procedures had been performed every year, estimated Dr. William Maisel, deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health.
However, when asked about the investigation, Johnson and Johnson/Ethicon told CBS News that the FBI had not contacted them about the devices.
The FBI has spoken to at least one of the affected patients about the devices. Dr. Amy Reed, an anesthesiologist and mother of six, was one such patient. She became a critic of the devices after she underwent a hysterectomy that was performed using a morcellator in 2013. Post surgery testing showed that she had cancer that had spread throughout her abdomen.
Reed’s husband, Dr. Hooman Noorchashm, told CBS News the couple had contacted the FBI starting in late 2013 and “finally, agents in New Jersey listened.” He told CBS that they had been interviewed last October and this year about their concerns with the device.