An FDA Investigation into Power Morcellators Focuses on How Much Johnson & Johnson Knew About the Devices’ Risks

The U.S. Food and Drug Administration (FDA) wants to know exactly how much Johnson & Johnson (J&J) knew about the dangers of surgical tools known as power morcellators before pulling the devices off the market last year.

The inquiry comes after the FDA warned last November that morcellators should not be used on the vast majority of women. Many hospitals and national health plans have either stopped using the tool or are considering limits. Power morcellators, which cut up benign uterine growths called fibroids so the tissue can be removed through tiny incisions, were once used in tens of thousands of procedures each year, according to WSJ.

About one in 350 women undergoing fibroid surgery have undetected uterine sarcomas, the FDA said in April 2014, and power morcellation can either spread the cancer or worsen it. The information prompted federal officials to call for a “black-box” warning on the tools in November 2014. Last July, J&J pulled the tools from the market entirely, though other manufacturers continue to sell them. J&J denies the company is under investigation, WSJ reported.

In 2006, Robert Lamparter, a former pathologist at Evangelical Community Hospital in Lewisburg, Pa., led the company to revise it’s instructions for use of power morcellators when he communicated via e-mails and letters that he had noticed an increase in morecellated specimens in his lab. Dr. Lamparter said in the communication viewed by WSJ that he had a variety of concerns including the potential for an undetected cancer to be inadvertently spread by the device. Gynecologists at his hospital found an unexpected malignancy at least once a year, he said. J&J’s instructions had already recommended that physicians who suspected or knew of malignant tissue should use a “tissue extraction bag” – a bag used to remove tissue from the body – with the tool. Lamparter said the FBI interviewed him on May 12 about his communication with J&J.

The FBI has also interviewed a retired pathologist who alerted J&J about potential problems with the laparoscopic power morcellators in 2006; a doctor who went public after her own cancer was worsened by the tool in 2013; and a California woman who has collected the names of nearly 400 patients and families of patients who may have been harmed by the device, according to WSJ.

 

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