(Corrects lawsuit detail in the 16th paragraph.)
The recall of a medical tool commonly used in hysterectomies means more than 50,000 women who get the procedures each year will face more painful options.
U.S. regulators have warned that the devices known as power morcellators, used to shave uterine tissue into tiny pieces that can be extracted without surgery, may also spread cancer in the body. Johnson & Johnson (JNJ), the largest maker of the devices, withdrew them from the market last week, raising questions about other approaches used for hysterectomies.
The operation is often done to remove fibroids that can cause heavy menstruation, stomach pain, constipation and urination troubles. Options that don’t use morcellation include removing the uterus through the vagina, possible only if the uterus isn’t too large, or surgery that can be either open or involve a smaller incision low on the abdomen, doctors said.
The procedures “may mean that recovery is a little longer with a little more pain,” said Isaac Schiff, chief of obstetrics and gynecology at Massachusetts General Hospital in Boston. “But we don’t have to worry, God forbid, that if the woman has cancer that we have upstaged it.”
Leiomyosarcoma is the uterine cancer doctors are most concerned about because it can look like a fibroid and is hard to detect, said Jason Wright, director of gynecologic oncology at Columbia University Medical Center in New York.
The malignancy is an aggressive cancer with a cure rate of only 75 percent even when it’s caught early, according to Wright. Once it spreads, survival is poor, he said.
Schiff placed a moratorium on power morcellation in his hospital in December when he first heard about the risk.
A Boston anesthesiologist, Amy Reed, was diagnosed with advanced leiomyosarcoma after undergoing the procedure, and her husband, a cardiothoracic surgeon, was petitioning the government to stop its use. A study led by Wright, published last week in the Journal of the American Medical Association, found as many as 1 in 368 women who undergo morcellation may have undetected cancer.
The doctors’ lobbying has spurred controversy in the field since morcellation was considered an improvement over open surgery, which is painful, can take six weeks for recovery and carries higher risks of complications and death.
The newer procedure uses the whirring blades of a tiny machine to slice off pieces from the uterus and the fibroids that are small enough so the tissue can be removed without slicing opening the woman’s abdomen.
The decision made by New Brunswick, New Jersey-based J&J will accelerate the retreating use of morcellators, Schiff said in a telephone interview.
“What’s going to happen is that more and more institutions will stop doing the procedure now that J&J has asked for the morcellators back and there is a lot of publicity,” Schiff said. “As far as I am concerned, the risk is just too great until we find a safer way to do it.”
For women with a small uterus, doctors can remove the organ through a cut in the vagina, Schiff said. Those that are slightly larger can be taken out via a bigger incision in the lower abdomen, he said.
Women with a big uterus, which can stretch as large as seen in a five months pregnancy, should get abdominal surgery anyway since the anatomy may be distorted and there can be more complications, according to Schiff.
In some cases, doctors are doing the procedure with special bags designed to capture the tissue and prevent the spread of any malignant cells, though they can interfere with the procedure and their usefulness isn’t known.
Legal ramifications may also crimp use of the devices. Only a handful of suits have been filed so far against J&J in state courts around the U.S. over the morcellator devices, Bryan Aylstock, a lawyer representing some women who are considering suing the company, said in an interview. The company may ultimately face more than 5,000 claims he added.
Some doctors argue the approach should remain available to women, provided they are at low risk for cancer and have been told about the dangers. The devices are made by a number of smaller companies, including Karl Storz GmbH & Co., Richard Wolf Medical Instruments Corp., LiNA Medical and Blue Endo, and remain on the market.
Women past menopause with newly developed fibroids should always undergo open surgery, said Marie Paraiso, head of female pelvic medicine at the Cleveland Clinic in Ohio. Young women, those under age 40 who have been well monitored and managed, should be able to get minimally invasive surgery, she said.
The clinic has suspended use of power morcellation until the U.S. Food and Drug Administration issues guidelines for the proper use of the technology. Paraiso is head of the medical center’s task force and a member of other national health groups’ efforts to determine how the devices should be used.
The literature suggests certain groups of women have less than a 1 in 7,000 risk of having undetected cancer in the uterus before a hysterectomy, she said. Few studies have looked at what happens to women with cancer who undergo morcellation, she said.
“We as physicians need to talk to our patients about what the true risks are,” she said in a telephone interview. “We also need to make wise choices about who we take to the operating room.”
There’s not enough information currently available to help pinpoint which women have a low level of risk and would benefit the most from power morcellation, the doctors said. Wright’s finding that 1 in 368 women getting morcellation had undetected cancer included a variety of uterine tumors. He wasn’t able to determine how much damage the procedure did, he said.
“There are still a lot of unanswered questions,” he said in a telephone interview. “We don’t know if it increases the spread of the disease or impacts the outcomes. Patients need to be aware of the risks and discuss them with their doctors. But I think there probably are some women, especially younger women, who may benefit from power morcellation.”
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