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Dr. Charles E. Miller, director of minimally invasive gynecologic surgery at Advocate Lutheran General Hospital, Park Ridge, Ill., described these data as "compelling," with well-presented information that stratifies risk by age that can be used to help properly counsel patients.
The marked difference in risk among women under age 40 is particularly important, he said. Dr. Miller performs about 250 morcellations per year and has had only one patient with a sarcoma, a woman in her mid-40s, which he said reflects the younger age of his patients.
"If we can better identify age groups where that risk is higher and do the treatment that is appropriate in that age group, then I think we’ve come a long, long way," he said in an interview. There are always outliers, and unfortunately, women in younger age groups develop sarcomas, but there are also the risks of more invasive surgery that should be considered, he added.
"There’s always going to be risk, and there’s always going to be decision making with surgery," and while there is a need for better ways to identify those patients at risk, currently, "all we can hang our hat on now is stratifying [risk] with age," Dr. Miller said.
On July 10-11, the FDA held a meeting of its Obstetrics and Gynecology Devices panel, to review the safety of LPMs during uterine surgery for fibroids, Among the questions the panel was asked was whether there were characteristics of patients – such as age, physical exam findings, and imaging test results – that could help identify patients who might be at a higher risk of a sarcoma.
The FDA is currently reviewing the safety of LPMs in women undergoing surgery for presumably benign fibroids, an issue that has received widespread attention this year and resulted in the FDA’s safety communication in April – largely due to the case of Dr. Amy Reed, an anesthesiologist who was diagnosed with stage IV leiomyosarcoma after undergoing a hysterectomy with morcellation at age 40 last year. She and her husband, Dr. Hooman Noorchashm, a cardiothoracic surgeon, are leading a campaign to highlight these risks, including a petition on change.org calling for a halt to morcellation during minimally invasive and robotic-assisted hysterectomy and myomectomy.
The authors of the JAMA report had no disclosures. Dr. Wright and one of the other authors, are recipients of National Cancer Institute (NCI) grants; another author is a recipient of an NCI fellowship. Dr. Miller disclosed that he is a consultant to Ethicon Endo-Surgery. Ethicon is a morcellator manufacturer.
