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The Federal Bureau of Investigations (FBI) has reportedly started a probe into what Johnson & Johnson and it’s Ethicon subsidiary knew about the risk of spreading uterine cancer with laparoscopic power morcellators and when they knew it.
Johnson & Johnson’s Ethicon unit was one of the leading manufacturers of power morcellators, which are surgical devices used in recent years during minimally invasive hysterectomy and uterine fibroid removal surgery to cut up and remove tissue through a small incision in the abdomen. However, use of the surgical device has been linked to a risk of spreading cancerous tissue that may be contained and hidden within the uterus, rapidly disseminating the aggressive uterine cancers.
According to a report by the Wall Street Journal, a number of sources close to the company and familiar with uterine fibroid surgical device cancer risks say they have been interviewed by the FBI in recent months. However, company officials have not indicated that they are aware of any investigation.
The FBI’s Newark, New Jersey office is reportedly overseeing the investigation, which comes nearly a year after Johnson & Johnson’s Ethicon unit issued a power morcellator recall, deciding to stop manufacturing and selling the devices. At the time, Ethicon commanded about three-quarters of the morcellator medical device market, and the company indicated that it decided to exit the field amid concerns that there is no way to make the devices safe.
For women with hidden or unsuspected cancer contained within the uterus, use of a power morcellator during uterine fibroid surgery may cause the spread of leiomyosarcoma, endometrial stromal sarcoma or other cancerous tissue. The rapid dissemination of the cancer to other areas of the body may greatly impact the woman’s chances for long-term survival and impact their overall quality of life.
Reports suggest that Johnson & Johnson may have been warned nearly a decade ago about the risks of upstaging undiagnosed cancer with morcellation during uterine fibroid removal surgery.
That warning came from Dr. Robert Lamparter, a former pathologist interviewed by the FBI earlier this month, according to the Wall Street Journal. Lamparter wrote to Ethicon in 2006, warning them that the device may be putting lives at risk by spreading cancer cells. The manufacturer acknowledges he warned them, and say they responded by trying to change the instructions on the devices to make them safer.
Last summer, in 2014, both Johnson & Johnson and a panel of FDA advisors determined there was no way to make morcellation safer for women.
In a widely criticized move, the FDA announced in November that it will allow hysterectomy morcellators to remain on the market with substantially stronger warnings about the risk of cancer and more limited indications for appropriate use of the devices.
Many hospitals have already announced that they will no longer perform a hysterectomy with morcellation, and many experts agree that the vast number of prior procedures performed involving the device are no longer appropriate.
Manufacturers of the devices now face a growing number of hysterectomy morcellation cancer lawsuits filed on behalf of women diagnosed with advanced stage cancer after the device was used, alleging that inadequate warnings were provided for consumers and the medical community.