Defective medical devices update: The FBI has launched an investigation into whether a medical device manufacturer was aware that use of the surgical device was potentially dangerous.
The FBI investigation is focusing on the danger surrounding use of power morcellators in general and on Johnson & Johnson, the leading manufacturer of the devices before Johnson & Johnson voluntarily withdrew its products from the market.
Prior to an FDA safety alert in April 2014, power morcellators were frequently used in laparoscopic hysterectomies. Approximately 500,000 hysterectomies are performed in the United States every year. Approximately 40% of hysterectomies are done because of uterine fibroids. Power morcellators were used in about 25 percent – 50,000 – of these hysterectomies.
In a power morcellator laparoscopic hysterectomy, the uterus is cut into small pieces that are removed through small incisions in the abdomen. If a previously undiagnosed cancer is present and the cancerous tumor is sliced or “morcellated,” malignant cells can be spread throughout the abdominal cavity, resulting in numerous new tumors and a poor long term prognosis. Once the cancer has spread, it is generally fatal.
Shortly after the FDA safety alert, Johnson & Johnson stopped selling power morcellators and advised medical providers of the recall. However, there is evidence that Ethicon – a wholly owned subsidiary of Johnson & Johnson – had been advised by a pathologist in 2006 of the risk of cancer being spread by morcellators. The pathologist had observed a large number of morcellated cancer samples in his laboratory. He advised the company “If a morcellation is done, the patient’s survival is jeopardized.”
The Ohio pharmaceutical and medical device attorneys at Clark, Perdue & List are experienced in representing individuals who have been harmed by dangerous drugs and defective medical devices. They are investigating claims in which power morcellators spread uterine cancer. If you or a loved one have been diagnosed with uterine cancer following a laparoscopic hysterectomy using a pwoer morcellator, call Clark, Perdue & List.