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The U.S. Food and Drug Administration (FDA) announced on Monday that laparoscopic powered morcellators can spread cancer, so that they should not be used in treating the majority of women having their uterine fibroid growths removed.
Morcellators are devices that chop the tissue inside the woman’s uterus into tiny pieces, making the surgery less complicated and the recovery of the patient faster. But the new FDA warning states that
“uterine tissue may contain unsuspected cancer [and] the use of laparoscopic power morcellators during fibroid surgery may spread cancer and decrease the long-term survival of patients.”
FDA is recommending “box warning” labels to be added to the devices, underlining the risks of using the product plus two cases when the morcellator should never be used. Women that want to remove their uterine fibroids and are going to or have completed menopause as well women that would need to undergo a hysterectomy should never use the morcellator. What is more, any tissue that is known to be suspect or cancerous should definitely not be morcellated.
On the other hand,
“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 [still] be candidates for this procedure,”
the experts added.
Fibroids are relatively common in older women, but they don’t have to be removed unless causing excessive menstrual bleeding, pain or anemia. The morcellation procedure can release the cancerous cells lurking in the uterus tissue or in fibroids into other parts of the abdomen. Moreover, what worries specialists is that in one out of 350 procedures, the tissue considered to be benign proved out to be malignant.
While Dr. William Maisel of FDA’s Center for Devices and Radiological Health said that their main concern is to assure the safety of the patients, Dr. Hal Lawrence, executive vice president of the American College of Obstetricians and Gynecologists stated that FDA’s warning is a bit confusing, explaining that there are many cases where older women have fibroids for years, but they are operated for some other reason. In such cases, a morcellator can safely be used, contradictory to FDA’s recommendations, Lawrence believes.
Almost 600,000 U.S women go through a hysterectomy procedure every year. Experts say that for about 40% of the cases, the surgery is done because of the fibroids and about 10% use morcelattors.
