A group of physicians and women’s health advocates on Tuesday sent a letter asking the U.S. Food and Drug Administration to rescind or revise its 2014 warning that curtailed the use of a tissue-slicing device in minimally-invasive gynecological surgeries.
The device, an electric morcellator, enables uterine tissue to be cut up and removed through tiny abdominal incisions. But the FDA concluded the device could accidentally spread and worsen a hidden uterine cancer called leiomyosarcoma in as many as 1 in 350 women who have a hysterectomy to treat fibroids – common benign growths that can cause abnormal bleeding. The FDA recommended against the use of power morcellation in most women, prompting most hospitals and insurers to restrict or ban it.
In their open letter to the FDA, 48 experts in gynecology and related specialties argued that without power morcellation, tens of thousands of women with fibroids may have to undergo major surgery with large abdominal incisions each year. The more invasive operations require longer hospital stays, longer recovery time, and increase the risk of complications such as infection. (Gynecological medical groups have also taken the position that morcellators still have a valuable role in patient care.)
The letter cited studies that estimate the risk of spreading a leiomyosarcoma during surgery for presumed fibroids to be between 1 in 1,960 to 1 in 4,360 – lower than the FDA’s estimate.
“The FDA’s estimate appears to overstate the risk,” said obstetrician-gynecologist William Parker, who spearheaded the plea to the agency. He is director of minimally invasive gynecologic surgery at UCLA Medical Center, Santa Monica.
Parker also is the lead author of a commentary opposing the FDA morcellation guidance that will be published in the January issue of the journal Obstetrics & Gynecology.
The list of signers of the open letter includes: gynecologic specialists from Yale, Johns Hopkins, Duke and Baylor Universities; women’s health activist Judy Norsegian, co-founder of Our Bodies, Ourselves; esteemed breast cancer surgeon Susan Love; and Carla Dionne, founder of National Uterine Fibroid Foundation.
In response to the open letter, the FDA said in an email that its guidance was formulated after an advisory committee meeting at which patients, health care providers, researchers, device manufacturers and others testified. “At this time, the Agency’s recommendations have not changed. We welcome the continued scientific dialogue concerning the available evidence about benefits and risks associated with power morcellation, and will notify the public if our recommendations change,” the FDA emailed.
The FDA issued its 2014 guidance in response to a campaign calling for a complete ban on morcellators. The campaign was launched two years ago by Amy Reed, a University of Pennsylvania anesthesiologist, and her husband Hooman Noorchashm, a cardiac surgeon at Jefferson University Hospital.
Reed’s hidden leiomyosarcoma was spread when she had a hysterectomy with morcellation in October 2013 in Boston, where the couple and their six children lived at the time. She has been battling the aggressive cancer since then, and has had three recurrences.
Noorchashm has harshly criticized gynecological medical groups and their leaders for not totally rejecting morcellation, calling their position “unethical” and “negligent.”
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