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on Apr 18th, 2014 and filed under FDA Discourages Procedure in Uterine Surgery – New York Times
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Doctors should stop using a procedure performed on tens of thousands of American women a year in the course of uterine surgery, because it poses a risk of spreading cancerous tissue, the Food and Drug Administration said Thursday.
The procedure, power morcellation, involves using a device to cut tissue into pieces that can be pulled out through the tiny incisions made during minimally invasive surgery. The devices, known as morcellators, have been widely used in laparoscopic operations to remove fibroid tumors from the uterus, or to remove the entire uterus.
The action on Thursday does not take them off the market or ban their use, but âdiscouragesâ doctors from using them in hysterectomies or fibroid surgery.
Morcellators were allowed onto the market in the 1990s without the usual clinical trials in patients because they were similar to other devices that had already been approved â a process that critics of the agency say can lead to safety problems like the one that has now been recognized.
Photo
Dr. Amy Reed and her husband, Dr. Hooman Noorchashm, are campaigning to end the practice of morcellation. They believe it spread Dr. Reed’s previously undetected cancer. Credit Matthew Cavanaugh for The New York Times
The F.D.A. became concerned about morcellators because of recent news reports about patients apparently harmed by them, said Dr. William Maisel, deputy director for science and chief scientist at the agencyâs Center for Devices and Radiological Health. He spoke at a telephone news conference on Thursday.
A case in Boston, first reported in December, drew national attention to the cancer risk. The patient was Dr. Amy Reed, 40, an anesthesiologist and the mother of six children, the youngest a 1-year-old. Dr. Reed had a hysterectomy because of fibroids in October, at Brigham and Womenâs Hospital. A biopsy after the surgery found a hidden sarcoma, an aggressive type of cancer. Morcellation had spread the tumor around inside her pelvis and abdomen, causing advanced, Stage 4 cancer.
Dr. Reedâs husband, Dr. Hooman Noorchashm (pronounced NOOR-chash), is a cardiothoracic surgeon, and he said he was horrified to learn that tissue had been minced up inside his wifeâs body. One rule that surgeons are taught, he said, is that cancers or potentially cancerous tissue should be removed whole and not broken up or cut, to avoid spreading the disease.
The couple began a relentless campaign to stop morcellation, hoping to spare other women from what had happened to Dr. Reed. They contacted reporters, hospitals, other doctors, legislators, the F.D.A. and medical societies, sending thousands of emails. On Thursday, they felt their efforts to save other women from what happened to Dr. Reed had paid off.
âI think itâs a major step in the right direction,â Dr. Noorchashm said in a telephone interview. But he added that the agency could have done more, like taking the devices off the market.
About a half-million women a year have hysterectomies to remove the uterus, and some 50,000 of those operations involve power morcellation of tissue containing fibroid tumors, the agency said.
Fibroids themselves are benign, but can sometimes hide cancers. If an unsuspected cancer is present, as in Dr. Reedâs case, the rapidly spinning blades of a morcellator can spray cancer cells around and speed the progression of the disease.
Sarcomas are a particular concern, because they are aggressive and almost never detectable with imaging or other tests before surgery. The diagnosis is usually made only after surgery, when the tissue is biopsied. By then, if a morcellator was used, it is too late to prevent the spread of the cancer, and the womanâs chances of long-term survival are significantly worsened, the agency said.
The Food and Drug Administration said that one in 350 women who have a hysterectomy or fibroid removal have unsuspected sarcomas. That figure, based on a review of the medical literature, was considerably higher than earlier estimates that gynecologists had been using, which ranged from one in 500 to one in 10,000, Dr. Maisel said.
Dr. Maisel said that although his agency had the authority to ban morcellators, it had chosen not to because there might still be some women for whom the procedure is a good option. When fibroids are large, morcellation may be required if a patient wants minimally invasive surgery, which avoids big incisions, shortens recovery time and reduces the risk of blood loss, infections and other complications.
Dr. Maisel said that doctors and patients could weigh the risks on a case-by-case basis, adding that sarcomas are more common in older women. The agency emphasized that women must be informed of the risks, something that has not been routinely done, in part because the threat was thought to be vanishingly small. Indeed, many women having hysterectomies were not even told that morcellation was being performed.
The drug agency is continuing to study the procedure and the devices and will meet with an advisory panel to review them, probably this summer, Dr. Maisel said.
For women who want to avoid morcellation, the agency listed other ways to deal with fibroids, including various operations that do not use the devices, drug therapy, techniques that shrink fibroids by blocking a uterine artery, and high-intensity focused ultrasound.
Some doctors and hospitals have said that morcellation can be made safer by performing it inside a bag to prevent tissue from spraying around.
But Dr. Maisel warned: âIt is not a panacea. It will not completely remove the risk.â Bags can tear, he said. And not all surgeons are trained in using them. The bags make it harder for doctors to see what they are doing, and there have been reports of organ damage during procedures involving them.
For Dr. Reed and her family, the results of her surgery have been devastating. The prognosis for advanced uterine sarcomas is dismal. She and her husband researched the disease, and decided that her best hope lay in radical surgery.
In November, a month after the hysterectomy, she had a grueling seven-hour operation in which a surgeon removed her appendix, gallbladder, ovaries and other tissue to which the cancer might have spread, and then pumped her abdomen and pelvis full of heated chemotherapy.
The surgeon estimated that she now has an 80 percent chance of surviving 10 years. After the surgery, she underwent more chemotherapy. She has one more round to go, her sixth. She hopes to return to work in June. But soon after that, she and her husband will leave their jobs in Boston and move with their six children to the Philadelphia area, to be closer to their families.
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