FDA warns against procedure to remove uterine growths; says it could spread hidden cancer

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WASHINGTON -- 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 that 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." Dr. Maisel acknowledged that the agency was spurred to action -- or at least moved more quickly -- because of 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 emailed numerous regulators, doctors and lawmakers, written to medical journals and lobbied hospitals. The couple started a Change.org petition to end the practice.

Dr. Noorchashm said Thursday that he appreciated the FDA's relative speed in addressing the problem. "You don't even have to be a doctor to recognize that if tissue or a tumor has malignant potential, you should not mince it up inside someone's body," he said. "That's just bad medicine."

Many women develop uterine fibroids -- benign growths that originate in the muscle tissue in the wall of the uterus. While many fibroids don't cause any problems, others can result in frequent urination, prolonged menstrual bleeding and pelvic pain.

Of the more than 500,000 hysterectomies performed in the United States each year, about 11 percent, or more than 50,000, involve morcellation, according to the American Congress of Obstetricians and Gynecologists. Some doctors advocate performing a morcellation only when using an "isolation bag" in an effort to minimize the spread of tissues, but that method isn't foolproof, as the bags can break.

"When you consider what the benefit is, which is a shorter hospital stay and less pain, then consider what the risk is -- this could kill you -- most women would not choose that risk if they really understood what is at stake," said Diana Zuckerman, president of the Cancer Prevention and Treatment Fund.

Even before Thursday's FDA announcement, the push to limit uterine morcellations had gained traction. In February, Temple University Hospital issued guidelines instructing surgeons not to perform the procedure on fibroids over a certain size. Doctors may use the procedure for smaller fibroids only after informing patients about the risks and in most cases using isolation bags.

Even before that, prompted by Dr. Noorchashm's campaign, Massachusetts General Hospital and Brigham and Women's Hospital in Boston took similar measures. On Thursday, the heads of the obstetrics and gynecology at both Boston hospitals promptly notified their staffs to suspend use of power morcellation until further notice.

Margaret Jacboson, medical director of Whatcom Hospice in Bellingham, Wash., cried upon hearing of FDA's action Thursday. In March 2012, her sister, Elizabeth Jacobson, had a hysterectomy by morcellation. She didn't want to miss much work, and the promise of a minimally invasive procedure appealed to her.

But inside the large fibroid that a doctor shredded inside her lurked malignant cells that spread throughout her abdomen, her sister said. Soon Elizabeth was diagnosed with aggressive uterine cancer, then had a second surgery, rounds of chemotherapy and long stretches of misery.

She died on Jan. 8, 2013. "She suffered terribly," Dr. Jacobson said. "It devastated our family."

Thursday's news brought a measure of relief, she said, that other women might avoid the same fate, especially given that safer surgical alternatives already exist. "It's a victory," Dr. Jacobson said. "It's not okay to tolerate these deaths."



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