Power Morcellator

Johnson & Johnson is once again in the crosshairs of another medical device investigation. Ethicon, a division of J&J, is the largest maker of a highly controversial surgical instrument known as a power morcellator. The FBI has launched an investigation to determine if J&J continued to market the devices even after it was discovered they could spread a type of cancer.

The power morcellator was designed to be used in minimally invasive surgeries and is often used to remove the uterus. The tool has rapidly spinning blades that cut tissue into small pieces that can be removed from the body through small slits made during surgery. But it has been discovered that when the morcellator is used in women with undetected cancers, during removal of the uterus malignant cells are sprayed around the abdomen and can actually speed the progression of the disease.

Last November, the FFDA issued a statement saying that morcellator should no longer be used in “the vast majority” of women. However, the devices were left on the market. Last month Aetna, the nations third largest insurer, announced that it would stop covering routine use of the power morcellator. Their decision came on the heels of a 2014 FDA warning that women undergoing fibroid surgery have an estimated 1 in 350 risk of harboring the cancers called sarcomas, which was a much higher rate than had been generally realized.

In a New York Times report, it was revealed that a doctor had contacted an agent from the Newark F.B.I. office last fall, because he suspected that morcellator manufacturers and some doctors and hospitals using the devices had violated a federal law requiring that adverse events be reported to the F.D.A.  The New York Times also interviewed other doctors who had as far back as 2006 raised concerns with Ethicon about the potential for the morcellators to spread undetected cancer.

If Johnson & Johnson is found to have concealed evidence that power morcellators could spread cancer, it would fit with a pattern of behavior that has come to plague the company. Johnson & Johnson was at the center of one of the largest medical device failures in history, metal-on-metal hips. The company paid billions last year to settle claims over its flawed ASR and Pinnacle replacement hips after it was discovered the they had continued to market the devices even after they knew of the dangers. At present J&J is facing thousands of lawsuits over surgical mesh devices they manufactured, and again a pattern of concealing damaging information regarding its products has begun to emerge.

The FBI investigation of power morcellators has just begun, but the discovery that Johnson & Johnson is once again involved in another medical device controversy comes as no surprise.