FDA Strengthens Warnings On Uterine Surgical Tool
The device, called a morcellator, should no longer be used in the "vast majority" of women, the FDA says, because it can spread cancerous tissue.
The New York Times:
F.D.A. Issues Caution On Use Of Uterine Surgery Device That Can Spread Cancer
A power device used during uterine surgery in at least 50,000 women a year in the United States risks spreading cancerous tissue and should no longer be used in “the vast majority” of women, the Food and Drug Administration said on Monday. The tools, laparoscopic power morcellators, have been widely used in operations to remove fibroid tumors from the uterus, or to remove the entire uterus. Morcellators cut tissue into pieces that can be pulled out through the tiny incisions made during minimally invasive surgery. (Grady, 11/24)
The Wall Street Journal:
Surgical Tool Gets Strongest Warning
The top U.S. health regulator warned Monday that a common surgical tool shouldn’t be used on most women during hysterectomies, a decision that caps nearly a year of debate and is expected to sharply curtail a procedure that the agency said can spread hidden cancer. The Food and Drug Administration used its authority to call for an immediate “black box” warning for laparoscopic power morcellators, the strongest caution the agency issues. Typically, such warnings on product labels undergo a lengthy comment period before being completed, lawyers for device makers said. (Kamp and Levitz, 11/24)
The Wall Street Journal:
5 Questions About The FDA Warning On Morcellators, Uterine Fibroids
The FDA has warned against using laparoscopic power morcellators for the majority of women having growths removed from their uterus. The decision comes after a growing awareness that the devices can spread and worsen hidden cancers. (Burton, 11/24)
The Washington Post:
FDA Toughens Warning That Uterine Procedure Can Spread Cancer
The Food and Drug Administration strengthened its warnings Monday against the use of a controversial uterine surgical technique, recommending that doctors avoid using laparoscopic power morcellators to remove uterine growths in the vast majority of women because of the risk of spreading hidden cancers. ... The warnings, which come seven months after the FDA first recommended against the widespread use of the procedure, would inform patients that using power morcellators to remove uterine growths could unwittingly spread cancer inside their bodies and decrease the odds of long-term survival. (Dennis, 11/24)
USA Today:
FDA Warns Gynecologic Device Has Spread Cancer
The US Food and Drug Administration Monday warned against a gynecologic device that has spread cancer in women who thought they had harmless fibroids. In the last year, two-dozen women have reported that their cancer was made worse by the device, called a power morcellator, which turned a treatable condition into a life-threatening disease. (Weintraub, 11/24)
