on December 8th, 2015 No Comments
A group of gynecologists is calling for the Food and Drug Administration to reverse its 2014 ruling banning the use of a device called a power morcellator to remove uterine fibroids, or non-cancerous masses also known as leiomyomas.
The ruling stemmed from several high-profile cases and a concern that morcellators could chop up and spread tissue that might contain a rare but deadly cancer known as leiomyosarcoma. The FDA overstated the risk of morcellation and failed to consider the risks involved in more invasive surgeries needed to avoid using a morcellator, said Jonathan Berek, MD, the chair of obstetrics and gynecology.
Berek is the senior author of the paper published today in Obstetrics and Gynecology and one of 48 gynecologists, oncologists and women’s health advocates who sent an open letter to the FDA yesterday calling for a revision of the ruling.
With a morcellator, surgeons can remove fibroids with very small incisions, usually with a laparoscope, reducing the complication rate and speeding the recovery time needed for fibroid removal or hysterectomy using a large incision, Berek said. But the FDA estimated that 1 in 458 women undergoing the procedure could have an undiagnosed leiomyosarcoma that could be spread by the morcellator.
The gynecologists, with lead author William Parker, MD, from the University of California-Los Angeles, say the FDA is overstating the risk, because recent data analyses put the likely risk at no higher than 1 in 1,550-1,960 cases. In fact, a recent population-based study placed the risk as low as 1 in 4,360 women having surgery for fibroids. In addition, it isn’t even certain that morcellators actually spread the cancers, Berek said.
“A leiomyosarcoma is a highly malignant, rare tumor that tends to spread readily, most often prior to surgery of any type, regardless of whether morcellation is used in the operation,” he told me.
The ruling has had the unintended consequence that many women who might have benefited from a minimally invasive surgery, with lower risks, now undergo a more risky, invasive surgery, he said. The authors list 10 procedures affected by the FDA’s ruling.
In the paper, they suggest six steps that could improve the FDA’s ruling, including advising women of the risks involved with power morcellation and conducting more research into the biology of these rare malignancies.
Previously: Stanford expert weighs in on ovarian0-cancer screening recommendation, Stanford researchers protest NIH funding restrictions and “A historic moment for women”: FDA approves the first drug to treat hypoactive sexual desire disorder
Image by Lady Ro