FDA ‘discourages’ a type of uterine-fibroid surgery
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.
The New York Times
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 (FDA) said Thursday.
The agency is discouraging doctors from performing the procedure, which uses an electronically powered device to grind and shred uterine tissue so it can be removed through a small incision in the abdomen. Known as laparoscopic power morcellation, the technique is widely used to treat painful fibroids, either by removing the growths or the entire uterus.
The action Thursday does not take the devices off the market or ban their use but “discourages” 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 been approved.
Electronic morcellation was developed as a less invasive alternative to traditional surgery, in which the uterus or fibroids are removed through the vagina or a large incision in the abdomen. Studies suggest the device-assisted approach results in faster recovery and smaller scars.
At least 30 percent of women experience symptoms from fibroids — severe pain, heavy bleeding, bladder or bowel dysfunction, infertility or pregnancy complications — mostly in their late 30s and 40s.
Surgically removing the uterus is a key treatment because it is the only way to ensure fibroids do not return. Myomectomy, surgery that removes fibroids while leaving the uterus intact, is recommended for women who still want to become pregnant.
Fibroids are noncancerous growths, but the risk of disturbing undetected cancer tumors has long been debated by reproductive specialists.
The FDA 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 agency’s 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 from Needham, Mass., 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 Women’s 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.
Reed’s husband, Dr. Hooman Noorchashm, is a cardiothoracic surgeon, and he said he was horrified to learn that tissue had been minced up inside his wife’s 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 Reed. They contacted reporters, hospitals, other doctors, legislators, the FDA and medical societies, sending thousands of emails. On Thursday, they said their efforts to save other women from what happened to Reed had paid off. “I think it’s a major step in the right direction,” 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 Reed’s 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 rarely 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 woman’s chances of long-term survival are significantly worsened, the agency said.
The FDA 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, Maisel said.
Maisel said that although his agency had the authority to ban morcellators, it had chosen not to because there might 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.
Maisel said doctors and patients could weigh the risks on a case-by-case basis.
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 told morcellation was 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, 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 Maisel warned: “It is not a panacea. It will not completely remove the risk.” Bags can tear, he said. In addition, 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 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 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 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.
Information from The Associated Press is included in this story.