FDA Advises Against Power Morcellator Surgery in “Vast Majority” of Women
Fibroid removal surgeries should only rarely be assisted by a power morcellator, given its possible association with the spread of uterine cancer in women, federal regulators warned in November.
The U.S. Food and Drug Administration (FDA) issued a federal alert on November 24th that said the “vast majority” of women should not undergo uterine morcellation procedures, which incorporate a surgical tool that grinds up tissue so that it can be more easily extracted via a tiny incision. The warning followed a similar one in April 2014, that estimated 1 in every 350 women may have undiagnosed cancer cells prior to having fibroids removed, which can only be detected after they are biopsied. As a result, a woman may end up with severe uterine sarcoma or another serious 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 federal agency said the day of its alert.
Some Gynecologists Fuzzy on Power Morcellator Warning
NBC News reported shortly after the alert that some gynecologists are still unsure about when to use morcellators. The executive vice president of the American College of Obstetricians and Gynecologists is one such doctor, according to the article. “I am not saying that we totally disagree with the FDA,” he said. “I think the way it’s stated is a little confusing.” He goes on to explain the difference between a tumor and a fibroid, before pointing out that most fibroids are non-cancerous.
The fact is though, that hysterectomies are performed very frequently in the U.S., with 600,000 undergoing one each year, the FDA estimates. About 50,000 are performed through laparoscopic methods, which can include power morcellators, and 40 percent are done because of fibroids.
In the days that followed the FDA’s uterine morcellation warning, HCA Holdings, Inc. announced its decision to ban use of the device in 160 hospitals and 115 surgical centers it operates. The U.S. hospital operator is the largest in the U.S.
Earlier this year, the Johnson & Johnson subsidiary, Ethicon, pulled its power morcellators from the market after issuing a sales suspension in April. The market withdrawal was announced in July and affected several of its products.
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