FDA discourages uterine procedure
- Article by: Brady Dennis
- Washington Post
- April 17, 2014 - 7:34 PM
The Food and Drug Administration on Thursday took the rare step of urging doctors to stop performing a surgical procedure used on tens of thousands of woman each year to remove uterine growths, saying the practice risks spreading hidden cancers within a woman’s body.
The procedure, know as power morcellation, has long been used in laparoscopic operations to remove fibroid tumors from the uterus or to remove the uterus itself. It involves inserting an electric device into the abdomen and slicing up tissue in order to remove it through a small incision. The surgery is far less invasive than traditional abdominal operations.
But the FDA on Thursday agreed with a growing chorus of researchers and clinicians who oppose the procedure, arguing it can recklessly spread undetected cancers throughout the body and make the disease more lethal in the process.
The agency isn’t seeking to ban the practice or the roughly two dozen FDA-approved devices used to perform it, but hospitals and gynecologists are likely to abandon the procedure anyway, because of potential liabilities.
The FDA said its analysis determined that an estimated 1 in 350 women who undergo morcellation have an unsuspected form of uterine cancer called uterine sarcoma.
“The existence of the risk is not new,” said William Maisel, chief scientist at the FDA’s Center for Devices and Radiological Health. “What is new is that the magnitude of the risk appears to be higher than was appreciated by the clinical community.”
Maisel acknowledged that the agency was spurred to action — or at least moved more quickly — due to a high-profile campaign waged in recent months by a Massachusetts couple, both doctors, for a moratorium on the practice.
Anesthesiologist Amy Reed, a mother of six who last spring treated Boston Marathon bombing victims as well as one of the suspected bombers, underwent what was supposed to be a routine procedure last fall to end bleeding from fibroids. The procedure spread undetected, cancerous tumor fragments throughout her abdomen. Now she is battling stage-four leiomysocarcoma, a rare and aggressive form of uterine cancer.
Her husband, Hooman Noorchashm, a Harvard-affiliated cardiothoracic surgeon, responded by launching a campaign to ban the widely used procedure. He has e-mailed numerous regulators, doctors and lawmakers, written to medical journals and lobbied hospitals. The couple started a Change.org petition to end the practice.
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