The U.S. Senate delegation from New York want to see power morcellators, which have been linked to the spread of undiagnosed uterine cancer, pulled from the U.S. market, the Wall Street Journal reported last night.
The devices are used during laparoscopic surgeries to shred and remove supposedly benign uterine fibroids, but in patients who have an undetected type of uterine cancer the morcellators can spread the cancerous cells.
Last month Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon Endo-Surgery voluntarily asked for the return of its laparoscopic power morcellators used in fibroid surgeries, a few months after it suspended sales of the devices on FDA warnings of the cancer risk. Earlier in July an FDA panel failed to come to a clear decision on the cancer risk from laparoscopic power morcellators, despite outraged testimony from dozens of attendees.
Sens. Chuck Schumer and Kristen Gillibrand today plan to ask the FDA to request that medical device companies get morcellators off the U.S. market altogether, a Gillibrand spokeswoman told the newspaper. The legislators want the ban to stand "until additional risk assessments and patient and clinician education can be performed," according to a draft of the letter obtained by the Journal.
Schumer and Gillibrand also urged the watchdog agency to "seriously consider and not discount the testimony presented during the FDA’s July hearings by our constituents who devastatingly lost family members to cancer after a power morcellation procedure," the newspaper reported.