Uterine Fibroid Treatment Poses Cancer Threat, says FDA

Women with uterine fibroids could be subjected to a procedure to remove them that's dangerous and upping their risks of cancer, according to a warning issued this week by the Food and Drug Administration (FDA). The procedure, laparoscopic power morcellation, is used to remove fibroids but poses a small risk of spreading a very rare, but very fatal, form of cancer.

Anywhere from 20 to 80 percent of women can develop fibroids by the time they reach 50 years of age. They tend to afflict women of reproductive years, when estrogen, which fuels their growth, peaks. Not all women who get them develop the characteristic symptoms of heavy periods and pain, and nearly all fibroids are benign, meaning they aren't likely to cause tumors.

But a small percentage will—the FDA estimates that 1 in 345 women who undergo fibroid removal also have an unknown, undiagnosed form of rare uterine cancer called uterine sarcoma. "There is no reliable way to determine if a uterine fibroid is cancerous prior to removal," said William Maisel, MD, MPH, deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health, in a statement.

That's why the FDA is so concerned about this new procedure. In laparoscopic power morcellation, a small instrument with a rotating blade is inserted into the uterus and used to break up fibroids, which are then sucked out with a laparoscope. The concern is that during this process, cancerous cells can get sprayed onto healthy tissue, or even into the bloodstream, and spread to other parts of the body. In fact, one study found a nine-fold increase in risk of developing uterine sarcoma when power morcellation was used.

Even if they are benign, the broken-up fibroids can reattach to healthy tissue and cause more problems for women.

Laparoscopic power morcellation was first approved in 1995, and became popular because it's a minimally invasive procedure with lower risks of infection than other fibroid-removal procedures, and women who have it done are in and out of the hospital much more quickly; 60,000 procedures are done every year. But, says Diana Zuckerman, PhD, president of the Cancer Prevention and Treatment Fund, "FDA standards for approving medical devices are much too low." The approval process for these devices is far less stringent than the process required to get a drug to market.

In December 2013, the Cleveland Clinic and the Brigham and Women's Hospital in Boston both voiced concerns over the technique, announcing that they would begin better informing women of the risks, after an anesthesiologist who underwent power morcellation developed a very aggressive form of sarcoma.

Doctors from those hospitals conducted a study and estimated that anywhere from 1 in 400 to 1 in 1,000 cases of cancer develop from the procedure, but they also noted that a large number of women who get it aren't being told what caused it. "While many patients have been irreparably harmed by power morcellation devices that spread their undiagnosed cancer, surgeons and other health professionals rarely reported when that happened," Zuckerman says. "The voluntary system of reporting serious medical harm from devices, including deaths, is not working because most physicians are not reporting most incidents, regardless of how serious they are."

There are far more procedures to cope with fibroids that are accompanied with less risky side effects, including freezing them, ultrasounds to break them up, and medications that can shrink fibroids or control the estrogen that speeds their growth. And there's always the wait-and-see approach: If your symptoms are mild enough or only slightly annoying, you can wait it out. Fibroids can, but rarely do, interfere with pregnancy, according to the Mayo Clinic, and they usually shrink after menopause hits, when your hormone levels drop naturally. 

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