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While Rome Burns . . . FDA Fails to Respond to Morcellators and Uterine Cancer

According to legend, the half-mad Emperor Nero played his fiddle while the Eternal City was being consumed by flames. This story has little basis in historical fact (first, Nero actually did take some action to contain the fires raging in the city, and secondly, the fiddle wasn't invented until some 10 centuries later), but it serves as an apt metaphor for modern America – particularly when it comes to medical products that are causing injury and death and a corrupt government so beholden to corporate interests that it fails to regulate in any meaningful way.

Case in point – power morcellators. Already implicated in spreading potentially cancerous cells throughout patients' bodies, these devices have caused the deaths of at least three women. The most recent victim is a young woman from Rochester, New York, who underwent power morcellation two years ago. She succumbed to a cancer that spread as a result of the removal of benign fibroid cells.

On one hand, an article in the Journal of Minimally-Invasive Gynecology this past summer insists there is no connection between the use of power morcellators and the spread of cancer cells that may be hidden in apparently benign fibroid tissue. On the other hand, the Food and Drug Administration estimates that as many as one in 350 patients may have cancer cells lurking within fibroid tissue.

Despite its own evidence on the subject, the FDA's silence is deafening.

Increasingly, physicians are speaking out. At least three members of the U.S. Senate, all Democrats, have also written to the FDA expressing serious concerns about the device and the procedure. In a letter dated October 6, 2014, Senator Robert P. Casey of Pennsylvania, writing on behalf of his constituents, urged the FDA to “swiftly and closely evaluate the concerns that have been raised, and take any additional action necessary that is appropriate to safeguard the health of the public.”

Johnson & Johnson's Ethicon division has even voluntarily withdrawn the device from the market.

So...why is the FDA failing to act or even respond?

Only FDA Commissioner Margaret Hamburg knows the official reasons – and, as of this writing, she has yet to make those reasons public.

For more information regarding the Morcellator Lawsuit Litigation, visit our Morcellator Lawsuit Page.

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