Device recall means tougher surgeries

The recall of a medical device commonly used in hysterectomies means as many as 50,000 women who get the procedures each year will face more invasive options.

The U.S. Food and Drug Administration has warned that power morcellators, used to shave uterine tissue into tiny pieces that can be extracted through tiny abdominal incisions, may also spread hidden cancer into other parts of the body. Johnson & Johnson, the largest maker of the devices, withdrew them from the market two weeks ago.

In addition, Highmark Inc., one of the country's largest Blue Cross Blue Shield plan insurers with 5.2 million customers across Pennsylvania, West Virginia and Delaware, said it will stop coverage of laparoscopic power morcellation, effective Sept. 1, according to several news reports.

Hysterectomy is often done to remove fibroids that can cause heavy bleeding, constipation and other problems. 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 opens the abdomen or involves a smaller incision low on the abdomen, doctors said.

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 aggressive, with a cure rate of only about 75 percent even when it's caught early, according to Wright. Once it spreads, survival is poorer.

A Boston anesthesiologist, Amy Reed, was diagnosed with advanced leiomyosarcoma after undergoing the procedure at Brigham and Women's Hospital. She and her husband, a cardiothoracic surgeon Hooman Noorchashm, petitioned the government to stop its use.

The physicians, both trained at the University of Pennsylvania, recently moved with their six children to Yardley. Noorchasm said he will begin working at Thomas Jefferson University Hospital later this month.

A study led by Wright, published recently in the Journal of the American Medical Association, found that 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 initially considered an improvement over open surgery, which is painful, can take six weeks for recovery and carries higher risks of complications.

The morcellator uses whirring blades to slice off pieces from the uterus and fibroids that are small enough so the tissue can be removed without cutting opening the woman's abdomen.

The decision by New Brunswick, N.J.-based J&J will accelerate the diminishing use of morcellators, said Isaac Schiff, chief of obstetrics and gynecology at Massachusetts General Hospital in Boston.

"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 the vagina or via a bigger incision in the lower abdomen, he said.

Women with a big uterus - fibroids can stretch it to the equivalent of a five-month 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 the bags can interfere with the procedure and their effectiveness isn't known.