- Power Morcellators Used to Remove Uterine Fibroids Can Spread Cancer and Other Serious Diseases
- February 16, 2015 | Author: Wendy R. Fleishman
- Law Firm: Lieff, Cabraser, Heimann & Bernstein, LLP - New York Office
New medical research has raised further concerns over the use of power morcellators to remove uterine fibroids.
Power morcellators fragment or slice tissue into small pieces so that it can be removed from the body through a small abdominal incision. In the case of hysterectomies, minimally invasive procedures often result in shorter hospital stays than total abdominal hysterectomy. Until this year, tens of thousands of American women annually underwent in hysterectomies and myomectomies in which the surgeon used a power morcellator.
Over the past year, there have been numerous reports, however, of cancer being spread after hysterectomies using open power morcellation when it was unexpected that the patient had malignant turmors in her uterus.
Last April, the U.S. Food and Drug Administration expressed concern that the use of these devices could cause the spread of undetected uterine cancers.
In November 2014, the FDA issued a second Safety Alert, and announced that it would ask power morcellator manufacturers to add a new black box warning to their labels regarding their potential to disseminate cancer cells. The FDA Safety Alert noted that the prevalence of unsuspected uterine sarcoma (a cancerous tumor of connective or other nonepithelial tissue) in patients undergoing such procedures is 1 in 352, while the prevalence of unsuspected uterine leiomyosarcoma (a cancerous tumor that arises from smooth muscle tissue) is 1 in 498, which is higher than previously thought.
The FDA now advises against the use of power morcellators for the majority of women who require hysterectomies or fibroid removal surgery.
In addition to the risk of spreading cancer that was not believed present in the uterus, a new report raises the concern that power morcellators can spread non-cancerous but still diseased uterine tissue in the body during the hysterectomy.
Earlier this month, physicians reported in the Journal of Obstetrics and Gynecology on three cases of women who underwent minimally invasive hysterectomy and a power morcellator was used. In each case, the tissue removed from the women following surgery was tested and benign for any cancerous cells.
Nevertheless, within a year of their hysterectomy, the women developed serious, but non-cancerous, uterine diseases. Each had to undergo surgery to remove pelvic or peritoneal masses. Thus, "open power morcellators have an inherent design flaw," the physicians concluded, "as the device allows for bits of tissue to spread throughout the peritoneal cavity."