A German medical device company that manufactures controversial power morcellators – surgical tools used during some gynecological procedures – has issued a “cease and desist” letter warning a U.S. surgeon to stop his campaign to ban the surgeries for most women because the device has been shown to spread undetected uterine cancer, worsening women’s odds of survival.
Power morcellators are surgical tools fitted with a long blade that shred uterine fibroids or entire uteruses inside the body and remove them through a small incision in the abdomen. The procedures have been favored by some doctors over open surgeries because they are less invasive, leave less scarring, and offer less recovery time.
Dr. Hooman Noorchashm and his wife, physician Amy Reed, began lobbying the Food and Drug Administration (FDA) to restrict use of power morcellators after Reed underwent a hysterectomy procedure in 2013 and shortly after was diagnosed with stage IV uterine sarcoma, a rare form of the disease. Uterine sarcomas are difficult to diagnose before surgical tissue is removed.
Drs. Noorchashm and Reed theorized that power morcellation could spread cancerous tissue throughout the abdomen, seeding new cancer growth and making the disease more difficult to treat. Research backed up the couple’s concerns, and the medical community began to listen.
In April 2014, the FDA issue a safety alert warning that women had a 1 in 350 chance of having uterine sarcoma that could spread if they undergo power morcellation procedures. The agency began a review on the safety of the device to see if stronger measures were in order.
It was during that time, in August 2014, that The Karl Storz Group, manufacturers of a power morcellator device, issued a letter to Noorchashm to stop his campaign against the procedures or face legal action.
“KARL STORZ insists that you immediately stop your campaign against the Rotocut morcellator, and any other morcellator device of KARL STORZ, and that you stop defaming the device and/or the KARL STORZ management in the medical world or on the market place,” the letter states.
“We will no longer tolerate unfounded and unproven allegations such as the ones contained in your previous emails and we will hold you responsible. Should we get to know further public statements from you that our device and/or management would be responsible for your wife’s and/or other women’s uterine cancer, and/or aggravation of their cancerous situations, we would not hesitate to take appropriate legal actions to protect our good name and our rights.”
Noorchashm says he was unfazed by the letter and has no plans to stop his fight.
“This letter exemplifies an entire industry’s sentiments towards a deadly iatrogenic women’s health hazard—namely, upstaging of gynecological cancers using morcellators,” said Noorchashm. “Clearly, almost all morcellator companies, including Storz, had recognized that their devices have the potential to spread and upstage cancerous tissues—many of their user’s manuals stated as such.”
In November, the FDA chose to strengthen its stance on power morcellators, adding a black box warning to the device and recommending that the procedure not be used in most women.
Source: The Cancer Letter