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FDA Warns Against Device It Says Can Spread Cancer in Women

Image: U.S. Food and Drug Administration (FDA) headquarters

A view shows the U.S. Food and Drug Administration (FDA) headquarters in Silver Spring, Md. taken on Aug. 14, 2012. © Jason Reed / Reuters

The "vast majority" of women getting fibroids removed should not be treated using devices called morcellators, which grind up a woman’s uterus so it can be easily removed, the Food and Drug Administration said Monday.

The FDA issued a revised warning saying the chopping process can spread undetected cancer in women and should only be used in very specific cases. As many as one in every 350 women having the procedure to remove uterine fibroids have tumors in the uterus that haven’t been diagnosed, the FDA says. Using the morcellators can break up and spread the tumors inside the woman’s body.

“We believe that in the vast majority of women, the procedure should not be performed,” Dr. William Maisel of FDA’s Center for Devices and Radiological Health, told reporters.

“We believe that in the vast majority of women, the procedure should not be performed."

But the main group representing gynecologists says the FDA’s guidance is confusing and doesn’t take into account all the variables and uncertainties. Morcellators are commonly used to remove fibroids but they can also be used in other procedures, such as removing a prolapsed uterus, and those procedures pose a much lower risk.

The risks have been known for months and one manufacturer even asked doctors to return its device, but they are still being used too commonly, the FDA says. It says the devices need to be more clearly labeled so doctors won’t use them in the women at risk of having undetected cancer.

“Today, the U.S. Food and Drug Administration is taking immediate steps to help reduce the risk of spreading unsuspected cancer in women being treated for uterine fibroids,” the agency said in a statement.

“Uterine tissue may contain unsuspected cancer."

“Uterine tissue may contain unsuspected cancer. The use of laparoscopic power morcellators during fibroid surgery may spread cancer and decrease the long-term survival of patients,” FDA added.

There’s only a small group of women who might safely be treated using For example, some younger women who are interested in maintaining their ability to have children or wish to keep their uterus intact after being informed of the risks may be candidates for this procedure.

But Dr. Hal Lawrence, executive vice president of the American College of Obstetricians and Gynecologists, says FDA didn’t consult his group and says some of what the FDA is saying is confusing.

“I am not saying that we totally disagree with the FDA,” Lawrence told NBC News. “I think the way it’s stated is a little confusing.”

The problem is that there’s no good test to distinguish between a fibroid — which is almost always a benign growth on the uterus — and a tumor or a pre-cancerous growth, Lawrence says. “The overwhelming majority of fibroids are totally benign fibroids,” he said.

The FDA guidance suggests that the morcellators should only be used in young women — for example to remove fibroids but allow a surgeon to repair the uterus. But there are also older women who may have had a fibroid for years who are having surgery for another reason, Lawrence says. In those cases, it’s pretty clear the fibroid isn’t a tumor and they could safely be operated on with a morcellator.

There are some important benefits to using morcellators, Lawrence says. They can help reduce the dangers of more invasive surgery, so women can recover faster.

An estimated 600,000 U.S women get hysterectomies every year. Maisel said about 40 percent of hysterectomies are done because of fibroids and about 50,000 of these use laparascopic or "keyhole" surgery, which can include morcellators.