FDA panel considers ban, ‘black box’ warning on power morcellators

A 2-day meeting of the FDA’s Obstetrics and Gynecology Devices Advisory Committee on the safety of laparoscopic power morcellators produced recommendations, but the committee was not asked to advise as to whether the devices should be banned. However, the presentations and discussions did point to a need for better methods of distinguishing leiomyomas from leiomyosarcomas (LMS), additional training for physicians using morcellators, and the possibility of a “black box” warning on the devices as well as the need for specific informed consent procedures, such as a consent form that would be signed by both patient and physician. 

Held on the FDA campus on July 10 and 11 and attended by Contemporary OB/GYN, the public meeting included presentations by FDA, industry, medical professional societies, patient advocacy and research organizations, and the general public and discussion about and deliberation by the panelists on the data and perspectives offered by speakers. Issues posed by the FDA for panel recommendations included: (1) assessment of the magnitude of the risk of disease dissemination in women with unsuspected LMS who undergo morcellation; (2) potential intraoperative strategies for mitigating that risk; (3) identification of populations for which the benefits of morcellation outweigh the risks and vice versa; and (4) avenues for research on morcellation models.

Specialists in ob/gyn, gynecologic oncology, radiology, statistics/epidemiology, and general surgery, among others, were represented on the 15-member panel. Prior to the meeting, one previously announced panelist stepped down, reportedly because of a potential conflict of interest related to consulting fees from a device manufacturer.

In its Executive Summary for the meeting, the FDA estimated that based on currently available data, among women undergoing hysterectomy or myomectomy for presumed fibroids, 1 in 352 have an unsuspected uterine sarcoma and 1 in 498 have an unsuspected LMS. That rate is higher than had previously been quoted in some literature and prompted the FDA to issue a Safety Communication on April 17 discouraging the use of laparoscopic power morcellators in women with symptomatic uterine leiomyomas. In May, the American Congress of Obstetricians and Gynecologists issued a Special Report on Power Morcellation and Occult Malignancy in Gynecologic Surgery in which it noted the limitations of intraperitoneal bags for morcellation; advocated for a full discussion of risks, benefits, and alternatives when morcellation is being considered; supported a focus on training for the procedure; and identified a need for a national prospective morcellation surgery registry.

FDA’s analysis of cohort or cross-sectional studies of women undergoing hysterectomy or myomectomy for presumed benign leiomyoma, presented at the meeting, found that peritoneal dissemination and/or cancer upstaging to FIGO Stage III or IV may occur in 25% to 64% of cases in which an unsuspected sarcoma is morcellated. Patients with unsuspected sarcoma who undergo morcellation may have poorer disease-free survival and overall survival than women who do not undergo the procedure.

Based on an analysis of data from the Medical Device Reporting (MDR) and Manufacturer and User Facility Device Experience (MAUDE) database, Craig Sobolewski, MD, Assistant Professor and Chief, Division of Minimally Invasive Gynecologic Surgery at Duke University, noted that risks of electromechanical morcellation include visceral or vascular injury and dissemination of tissue fragments. Carmel J. Cohen, MD, Professor of Gynecology at the Icahn School of Medicine at Mount Sinai, NY, in a presentation on uterine sarcomas, noted their lack of presenting symptoms, difficulty in distinguishing LMS from leiomyomas with any techniques other than pathology, and the common path of metastasis from the pelvis to the lungs. Uterine LMS, he emphasized, do not develop from “degenerated” fibroids and risk factors include being African-American, exposure to tamoxifen or pelvic radiation, a history of retinoblastoma, and a history of leiomyomatosis and renal cell cancer.

Summarizing the key points of the panel’s discussions at the end of the 2-day meeting, FDA Deputy Director Clinical Aron Yustein, MD, cited:

• The major challenges in identifying uterine sarcoma before any surgical procedure is performed;

• The significant risk of dissemination, should an unsuspected LMS be morcellated;

• The FDA’s openness to innovation related to morcellation devices and accessories such as bags;

• The need for patient information and physician training about morcellation before the procedure is performed; and

• The need to acknowledge that real health issues exist with laparoscopic power morcellation.

As it continues to examine the safety of laparoscopic power morcellation, Dr. Yustein said, the FDA will take into consideration information from the meeting and other data as they become available. A docket for public comment on the issue-FDA-2014-N-0736-has been opened by the FDA and comments can be submitted in writing or electronically at http://www.regulations.gov through August 11.