Campaign against a medical procedure gains

The husband-and-wife doctors who have turned their personal tragedy into a public health crusade are getting traction.

Cardiothoracic surgeon Hooman Noorchashm and his wife, anesthesiologist Amy Reed, 40 - both trained in Philadelphia and affiliated with Harvard Medical School - want electric tissue-cutting morcellators banned from gynecologic surgery.

Power morcellation, introduced in 1993, enables tissue removal through tiny abdominal incisions, but in rare cases it can also spread a hidden uterine cancer called leiomyosarcoma.

Reed, a mother of six, has become the poster woman for that awful scenario. During a minimally invasive hysterectomy in October at Brigham and Women's Hospital in Boston, the morcellator hurled uterine tumor fragments that were implanted in her abdominal cavity. She now has stage-four leiomyosarcoma, and the hospital acknowledges the procedure likely worsened her prognosis.

Because of the couple's campaign, the Food and Drug Administration and gynecological groups are reviewing use of the devices. A few journals have criticized it, while a growing number of hospitals - most recently Brigham and Women's - have restricted it. Anecdotally, some wary women are opting for the pain and six-week recovery of traditional open-belly hysterectomy.

Meanwhile, the couple's change.org petition has been signed by thousands of people, including dozens who say they - or a deceased loved one - were diagnosed with leiomyosarcoma after morcellation.

But although a ban may sound like a no-brainer to the lay public - and Noorchashm insists it is - experts say the limited data on complications and the insidiousness of leiomyosarcoma make the debate far from simple.

Studies show leiomyosarcoma is ultra-rare, with an annual incidence of less than one in 100,000 women. Yet it is difficult to distinguish from ultra-common benign uterine growths called fibroids. The cancer has no reliable risk factors, symptoms, or screening methods. It can be dispersed during procedures less disruptive than morcellation. And it is notoriously aggressive.

Even when women are diagnosed while the cancer is confined to the uterus, about half die within five years, National Cancer Institute data show. A review of 219 patients at all stages treated since 1982 at Memorial Sloan Kettering Cancer Center found 90 percent progressed within 16 months.

"The discussion about morcellation so far has yielded as many questions as answers because the current system for monitoring surgical techniques and devices has deficiencies," two gynecological surgeons editorialized last month in the Journal of the American Medical Association.

Mark Woodland, obstetrics-gynecology director at Drexel University College of Medicine, said, "I applaud efforts that promotes education, awareness, and patient safety. But we have to be careful about leaving no room for negotiation because you don't want to throw out the baby with the bathwater. Is the morcellator an evil instrument? No. Is there a potential for bad outcomes? Yes."

The magnitude of that potential - the risks versus benefits - is at the heart of the controversy.

On the benefit side, gynecology has become increasingly minimally invasive because doing procedures through the vagina or tiny abdominal incisions reduces patient recovery time and complications. In 2002, 680,000 women had hysterectomies, almost 70 percent by open-belly surgery. By 2010, hysterectomies had fallen to 430,000, and 54 percent were open-belly, according to federal data.

About 11 percent of hysterectomies now involve power morcellation, says the American Congress of Obstetricians and Gynecologists.

What about the risks?

Most morcellator injuries to abdominal organs are not reported to the FDA, said Northwestern University's chief of gynecologic surgery, Magdy Milad, whose research found only 55 such reports over the last 15 years.

After morcellation, benign fibroid fragments are normally absorbed by the body, but occasionally they take root in the abdominal cavity, causing pain and other problems.

As for morcellating a hidden leiomyosarcoma, gynecologists have been faulted for downplaying that danger by citing the rate of all uterine malignancies: one in 10,000.

But since Reed's case, analyses of morcellation studies, few as they are, suggested the risk is actually between one in 400 and one in 1,000.

That is intolerably high, Noorchashm writes in e-mails to regulators, physicians, members of Congress, and journalists. He derides gynecologists' training and morals, and dismisses their efforts to improve safety by morcellating in an isolation bag.

"I find your field's attempt to defend morcellation extremely troublesome from an ethical and patient safety perspective," he e-mailed the minimally invasive gynecology society. "It appears that your specialty's primary motivation is to protect the industry of minimally invasive surgery . . . and not the patient herself. Your proposed bags will break and cancers will spill . . . Your 'informed consent' will do nothing to protect women, but will protect you in a courtroom."

The anti-morcellation campaign is clearly influencing women's choices.

"In the past week, I've counselled two young women with small fibroids who were at low risk [for cancer]," said Milad at Northwestern. "They chose open surgery because of this."

Milad and other experts say banning electric morcellators would not eliminate oncological risks. Leiomyosarcoma cells can spread through the blood and lymph systems as well as around a tumor, and the biology is barely understood. Theoretically, cells can be dispersed even by relatively controlled, contained procedures - including open abdominal hysterectomy.

"The fibroid can be as hard as your knee," Milad said. "If you want to take the fibroid and uterus out intact, you have to cut [the belly open] from the pubic bone to beyond the belly button. There's still a chance you're going to have to cut the fibroid manually. So there's a risk of cellular debris being left behind."

Teresa A. McMullin of Aston died at 57 in December 2011, 28 months after being found to have stage-three leiomyosarcoma, meaning it was in her abdominal tissue.

Her relatives signed the change.org petition and say they believe her cancer was disseminated during her hysterectomy - even though it was done vaginally without power morcellation.

Pamela H. Kurrey, the Chester County gynecologist who performed the surgery, said, "I've never used a power morcellator. Personally, that blade whirring around makes me nervous. . . . I pulled the fibroid into the vagina and took a scalpel and cut it."

"Teresa was aware that it wasn't an electric morcellator," her husband, Vincent, said. "I think the cancer could have been" spread by manual morcellation. "She did feel that way."

In 2008, Italian surgeons reported a case in which they worried they had spread a hidden leiomyosarcoma while removing it with a thin, lighted cutting instrument, or hysteroscope, inserted through the vagina.

Although the patient seemed cancer-free three years after extensive surgery and chemotherapy, her doctors wrote, "We cannot exclude that retrograde dissemination of disease through the fallopian tubes may occur during diagnostic or operative hysteroscopy, thus changing the prognosis. "

Noorchashm acknowledged that banning electric morcellators would get rid of the "most blatant" risk, not all risk.

"Gynecologists don't understand this notion that you shouldn't disrupt tissues inside the body that have malignant potential," he said.

He sees no room for compromise or delay, but others do. Better containment systems and diagnostic tests are in the works. Milad, for example, is studying the use of MRI imaging of the uterus.

Temple University Hospital, meanwhile, was the first center to clamp down. Not only are isolation bags required for morcellation, but fibroids larger than seven inches must be removed through a large incision, not minimally invasively.

"We decided it's the right thing to do," said Enrique Hernandez, Temple University's chair of obstetrics and gynecology."

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