After several years as the subject of controversy in the health care industry, a medical device is reportedly under investigation by the FBI. A version of the device, called a laparoscopic power morcellator, was taken off the market last year amid evidence that it spread cancer in some women treated with the product. Now, the FBI has apparently stepped in to look more closely into the use of the laparoscopic power morcellator.
According to CBS News, the FBI wants to find out what the largest manufacturer, Johnson & Johnson, knew about any problems associated with the morcellator. Physicians often used the device during procedures such as minimally invasive hysterectomies and the removal of benign uterine tumors. The device grinds up tissue for easy removal; however, it is believed that this action spreads cancer in women with previously undiscovered uterine sarcoma cancer.
Last year, the U.S. Food and Drug Administration issued at least two press releases about the device, citing a risk of worsening a patient's condition and recommending stronger warning labels. Johnson & Johnson removed its version of the device from the market following advice from Ethicon, a division of the company.
Reportedly, the FDA has not contacted Ethicon or Johnson & Johnson but has talked with at least one patient about the aftermath of a procedure using the device. The patient and her husband, both physicians, contacted the FBI after she underwent a hysterectomy utilizing the device in 2013. Reportedly, follow-up tests after her procedure revealed the presence of cancer, which had spread to her abdomen.
Even though Johnson & Johnson pulled its laparoscopic power morcellator last year, other manufacturer versions of the device remain available for use in medical procedures. This means it is possible for more women to suffer injury from the device. Denver area residents concerned about their own health following a procedure in which the device was used might consider speaking with an attorney to determine if grounds for a medical malpractice lawsuit exist.
Source: CBS News, "FBI investigating medical device that spread cancer in women," May 27, 2015