FDA/CDC

FDA: Laparoscopic power morcellators can spread malignant cells when used in women with occult uterine cancers*


 

Laparoscopic power morcellation appears capable of spreading fulminant uterine malignancies when used to remove uterine fibroids from women who have unsuspected uterine cancers.

A new Food and Drug Administration literature review of 23 studies found consistent evidence that women who undergo surgery using laparoscopic power morcellators (LPMs) for fibroids that were assumed to be benign may have an occult uterine sarcoma or leiomyosarcoma. In the FDA’s literature review of 12 studies from 2014 to 2016, women who received power morcellation were at a significantly increased risk of death, compared with those whose fibroids were removed by other methods.

The findings reaffirm the agency’s 2014 warnings about LPMs:

• LPMs are contraindicated in gynecologic surgery in which the tissue to be morcellated is known or suspected to contain malignancy.

• LPMs are contraindicated for removal of uterine tissue containing suspected fibroids in patients who are peri- or postmenopausal, or in candidates for en bloc tissue removal.

• Boxed warning: Uterine tissue may contain unsuspected cancer. The use of LPMs during fibroid surgery may spread cancer and decrease long-term survival of patients. This information should be shared with patients when considering surgery with the use of these devices.

FDA icon Wikimedia Commons/FitzColinGerald/Creative Commons License
“Since the FDA first issued warnings about the risk of spreading unsuspected uterine cancer from the use of laparoscopic power morcellators, we have continued to review new research to ensure our recommendations reflect the most current scientific evidence. Our latest analysis found a similar incidence of these hidden cancers to our estimate 3 years ago,” Jeff Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, said in a press release accompanying the FDA’s white paper.

“We recognize that some health organizations have reported a lower estimate of risk and that some groups continue to request that we scale back our recommendations. However, after looking at all the relevant data, we believe our estimates remain accurate, and our recommendation against the use of this device to remove fibroids in the vast majority of women is appropriate and critical to better protecting these women. We are committed to continuing to review new relevant data to assure patient safety.”

The review determined that 1 in 350 women undergoing hysterectomy or myomectomy for fibroids may have an occult uterine sarcoma, and that 1 in about 500 have an unsuspected leiomyosarcoma. The literature review clearly identified increased risk of uterine cancers and decreased survival when these women are treated with an LPM, as opposed to manual morcellation or en bloc removal.

Twelve studies of women with uterine cancers examined this outcome in comparison groups. LPMs were associated with a 2- to 3-times increased risk of disease recurrence, compared with manual morcellation or other fibroid removal methods. In some studies, disease-free survival was significantly shorter among those who had undergone an LPM procedure; others found a higher risk of death – including, in one study, almost a quintupling of mortality risk by 1 year (crude risk ratio, 4.75).

Device-related malignancies began appearing in 2013; since then, 262 cases have been reported. But after the 2014 warning, use of LPMs in this application has decreased sharply. Two studies examined this, one finding that LPM use in fibroid surgery dropped from 14% to 3% and the other, that it dropped from 11% to 0.02%.

“The agency also continues to recommend that the advantages and risks of using LPMs during fibroid surgery be thoroughly discussed between the patient and physician before surgery,” the paper concluded. “FDA continues to actively encourage and engage in research to evaluate outcomes for a range of treatment options for fibroids and support the development of safer alternatives for providing a minimally invasive approach.”

msullivan@frontlinemedcom.com

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