The Federal Bureau of Investigation (FBI) is investigating a medical device that was withdrawn from the market in 2014 after it was found to spread cancer in women. According to a news report in the Wall Street Journal, investigators are looking into what Johnson & Johnson, the largest manufacturer of the device known as laparoscopic power morcellator, knew about the problems.
The Problem with Morcellators
The morcellators were apparently used by surgeons during certain minimally-invasive hysterectomy procedures or to remove uterine fibroids. The morcellator ground up tissue so it could be easily removed through tiny incisions. However, when the device was used on women who had undiscovered uterine sarcoma cancer, it had the effect of spreading the cancerous tissue through the abdomen and pelvis.
The U.S. Food and Drug Administration (FDA) issued a warning about the cancer risk in April 2014 saying that morcellation could worsen the patient’s likelihood of long-term survival. In November, the FDA required a strong new warning on the product label. Ethicon, the division of Johnson & Johnson that made the devices, advised doctors to stop using them and pulled them off the market.
However, models made by other medical device makers still remain available. Tens of thousands of women have undergone these procedures. One patient who was interviewed by the FBI said she underwent a hysterectomy with a morcellator and follow-up testing showed she had cancer that had spread through her abdomen.
Product Liability Issues
All drugs and medical devices may have side effects. However, it is unacceptable when consumers who take these drugs or use medical devices with the hope of feeling better, end up suffering devastating consequences. Manufacturers of medical devices have the legal obligation to inform patients about the potential risks and dangers they face as the result of undergoing a certain treatment or using the device. When they do that, consumers can make an informed choice about the course of their treatment.
If you or a loved one has suffered severe health consequences as the result of a medical device, you may be able to seek compensation by filing a product liability claim against the manufacturer. Injured victims can seek compensation for damages including medical expenses, lost wages, hospitalization, rehabilitation, permanent injury, pain and suffering and emotional distress. A product defect law firm that has successfully handled similar cases will be able to advice victims and their families regarding their legal rights and options.