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Hospitals avoid morcellator for hysterectomies after FDA warning

Most Tampa Bay hospitals have halted a surgical technique used in many hysterectomies after a warning from the federal government that the procedure spreads an aggressive cancer in some women.

Tampa General Hospital, BayCare Health System and the Florida Hospital system have joined institutions across the country in suspending use of a motorized blade called the power morcellator. So have Bayfront Health St. Petersburg along with local hospitals owned by Community Health Systems. HCA also has asked its hospitals to heed the Food and Drug Administration's advice.

Used for decades, the device shreds tissue so it can be removed through the tiny incisions made in minimally invasive surgeries. But in rare cases, that shredding ends up spreading undetected cancer.

Meanwhile, two University of South Florida medical professors, Lennox Hoyte and Anthony Imudia, are building a low-cost device they believe could make the technique safer by containing the shredded tissue. They've filed for a patent and are finishing a prototype.

"We think it's huge," said Hoyte, chief of urogynecology at USF and Tampa General.

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Since the early 1990s, surgeons have seen the morcellator as one solution to a long-standing problem: Giving women with uterine growths called fibroids the option of minimally invasive, or laparoscopic, surgery.

In contrast to traditional open surgery, laparoscopy promises faster recovery times and fewer infections. But a uterus filled with fibroids can be too large to fit through small incisions. So the morcellator cuts up the fibroids so that the tissue can be easily removed in pieces.

Hysterectomies are one of the most frequently performed procedures in the United States, about 600,000 a year, according to the American Congress of Obstetrics and Gynecologists. Most are performed vaginally or abdominally. But about 44 percent of women between ages 40 and 49 chose laparoscopic surgery, and 16 percent of older women do so. Estimates suggest the morcellator is used on at least 55,000 cases each year.

The tool is used also on women who need only the fibroids removed, a procedure known as a myomectomy.

For years, physicians have known that in rare cases the tool can cut undetected cancer cells, hidden in the fibroids, and scatter the disease through women's abdomens.

But after several high-profile cases in which cancer spread as the result of the procedure, including that of a Boston physician treated at one of Harvard Medical School's teaching hospitals, the Food and Drug Administration in April issued a nonbinding warning against the device.

Though statistics vary, the FDA recently estimated 1 in 350 women who undergoes a hysterectomy or myomectomy for fibroids has an unsuspected type of cancer known as uterine sarcoma. In addition to being aggressive, the uterine sarcoma is insidious: It avoids detection and is almost always diagnosed after it has been removed and biopsied.

• • •

Without a reliable way of testing for the cancer, many hospitals are heeding the government's warning. Other options available to women include having the surgeon manually break up the fibroids with a scalpel or undergoing another type of procedure.

"Patient safety is our top priority," said Lisa Patterson, spokeswoman for BayCare. "We carefully reviewed the reports … and had discussions with physicians, clinicians and administrators and decided not to (use the device) until more information becomes available."

Several medical societies urged further review but said the procedure should remain an option for some women.

Imudia, the USF gynecology professor, said there are steps thought to reduce the risk, such as using the morcellator inside a bag, which is inserted into the patient to surround the tissue before it is cut up. But he said the bags are hard to maneuver.

Tampa General is developing a protocol that would let women at very low risk of cancer once again be eligible for the technique. But Hoyte said the more important step is to fix the problem. So he and Imudia are working on a "containment device," which would trap loose tissue as it is cut.

Hoyte said their device would create a work space for the morcellator. That would be easier, he said, than pulling a bag in and out of the body. The USF device would need FDA approval.

He said nationwide publicity around the recent cases "blew the lid" on the process. Many women, he said, may not have realized that surgeons were actually grinding tissue as part of the procedure.

Talking about risk levels isn't particularly persuasive for many patients, he noted, especially if they end up being in the minority of cases where something goes wrong.

"Now the patient and consumer is getting up and saying, 'Hey, I don't want you doing that,' " he said. "And that's reasonable."

This story has been updated to reflect the following correction: The Food and Drug Administration estimates 1 in 350 women who are undergoing a hysterectomy or a procedure known as myomectomy for fibroids has an unsuspected type of cancer called uterine sarcoma.

Jodie Tillman can be reached at jtillman@tampabay.com or (813) 226-3374.

Hospitals avoid morcellator for hysterectomies after FDA warning 06/07/14 [Last modified: Wednesday, June 11, 2014 11:41am]

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