An updated review of evidence by the US Food and Drug Administration (FDA) underscores concerns expressed in 2014 by the agency about use of laparoscopic power morcellators (LPM) for treatment of uterine fibroids. Conducted by the Center for Devices and Radiological Health (CDRH), the analysis spanned 42 studies, 4 systematic reviews, 4 decision analyses, and also medical device reports (MDRs) and data on changes in rates of hysterectomy or myomectomy in the past 3 years.
The goals of the review were assessment of (1) prevalence of sarcoma in women undergoing myomectomy or hysterectomy for presumed benign uterine fibroids; (2) clinical outcomes in patients diagnosed with cancer following morcellation during myomectomy or hysterectomy to treat presumed uterine fibroids; and (3) differences in patient outcome electric power morcellation versus manual morcellation and/or no morcellation.
In April 2014, FDA issued a safety communication warning against use of LPMs during most surgeries for fibroids. Seven months later, recommendations were made for labeling LPMs for gynecological or general indications with contraindication statements and a “black box” warning. The actions followed reports suggesting an association between use of LPMs during surgery in women with presumed fibroids and dissemination and upstaging of undiagnosed uterine sarcomas.
The new review showed a 1 in 225 to 1 in 580 prevalence of uterine sarcoma in women undergoing surgery for presume fibroids and a 1 in 495 to 1 in 1100 prevalence for leiomyosarcoma (LMS). In studies published from 2014 to 2017 in a fixed effects model, prevalence of uterine sarcoma was 0.328% (95% confidence interval [CI] 0.303-0.352) corresponding to 1 in 305 and prevalence of LMS was 0.175% (95% CI 0.148-0.202) corresponding to 1 in 750 women. Limited data showed an increase in occult sarcoma with age for both uterine sarcoma and LMS, with significant increases noted in women aged 60 and older.
Of the 262 MDRs received by FDA through April 17, 2017 that described dissemination of malignant cells in association with LPMs, 18 specifically claimed that the device was associated with upstaging of disease. The authors of the analysis noted, however, that submission of an MDR does not provide causality between a device and the reported event. Data on trends in use of LPMs since the issuance of the safety communications indicated that the rate of use of the devices in hysterectomies has fallen to < 0.1 procedures per 1000.
“While minimally invasive surgery conveys several significant advantages over open surgery for women with fibroids,” the report’s authors said, “the use of LPMs during these surgeries poses a risk due to the potential presence of unsuspected sarcoma in this population. FDA continues to caution against the use of LPMs in the majority of women undergoing myomectomy or hysterectomy for treatment of fibroids.”