Expert Commentary

Why FDA hearing on morcellation safety could drive innovation

Reaction from Cheryl Iglesia, MD, Advisory Panel Member, to FDA’s 2-Day Hearing


 

As a member of the Obstetrics & Gynecology Devices Panel FDA Advisory Committee, Dr. Iglesia digested the information presented at the hearing on July 10 and 11 and made her recommendations, along with her fellow panel members, for the fate of laparoscopic power morcellators to the FDA. Tune in to this special audiocast to hear Dr. Iglesia discuss the specific issues the panel weighed when making their final recommendations.

Dr. Iglesia is Director, Section of Female Pelvic Medicine and Reconstructive Surgery, MedStar Washington Hospital Center, and Associate Professor, Departments of ObGyn and Urology, Georgetown University School of Medicine, Washington, DC. She also serves on the OBG Management Board of Editors.

TRANSCRIPT

Janelle Yates: OBG Management Editorial Board Member Dr. Cheryl Iglesia attended the July 10th and 11th FDA hearing on microscopic power morcellation as a member of the Obstetrics and Gynecology Devices Panel Advisory Committee. In this audiocast, she describes the hearing and the panel’s recommendations as well as many of the fine points considered in weighing the risks and benefits of power morcellation. Dr. Iglesia is Director of the Section of Female Pelvic Medicine and Reconstructive Surgery at MedStar Washington Hospital Center, and Associate Professor in the Departments of Ob/Gyn and Neurology at Georgetown University’s School of Medicine in Washington, DC.

Dr. Iglesia, could you describe your role on the FDA’s Obstetrics and Gynecology Device Panel Advisory Committee?

Cheryl B. Iglesia, MD: I’m considered a special government employee and I have a 5-year term on the ObGyn Devices Panel. I was a member of the panel that reviewed vaginal mesh, and this is my second ObGyn devices panel as a consultant on power morcellation for laparoscopy. After the hearing, which was July 10th and 11th, we make recommendations as a panel but no final decisions are made until everything has been reviewed by officials at the FDA, and the FDA will come up with final decisions based in part on some of the recommendations that the panel has made. Therefore I can’t give you an official view, and what I’ll be talking about right now mostly represents my own opinion.

Ms. Yates: Just to review: What was the goal of the 2-day hearing, and whose points of view were represented to the panel?

Dr. Iglesia: The goal was to discuss the risk of disseminating unsuspected uterine malignancy with power morcellation. We talked on the panel about what the risk is of occult leiomyosarcoma in women with uterine fibroids. We talked about the preoperative screening evaluation process, talked about options for interoperative strategies to minimize or mitigate intraperitoneal fragmentation or dissemination of the tissue. They talked about various types of morcellators and, moving forward, if leiomyosarcoma was diagnosed, whether or not power morcellation upgraded an occult malignancy. And what the benchmarks should be for future devices, and whether or not future devices— not just for the power morcellators with containment, like containment bags—how they should be evaluated and tested moving forward. There was also some discussion about the role of registries.

Ms. Yates: What final recommendations did the panel make to the FDA?

Dr. Iglesia: Overall, there was a very long discussion about the risk of having an unsuspected sarcoma and the rates ranged from one in 350 to one in 7,450. What we as a panel realized is that while there are some indicators that could be suspicious for leiomyosarcoma, particularly on an MRI, that one cannot be 100% certain, particularly when you have a fibroid that’s degenerating, that it’s not just leiomyosarcoma but other occult malignancies.

The bottom line is the patients must be adequately worked up, particularly if there is abnormal bleeding. An evaluation would include normal cervical cytology, normal endometrial sampling, either sonograms or MRIs if indicated, and we talked about patient selection. In particular of being very worried about using morcellation in the postmenopausal woman who’s bleeding. We talked a lot about other options for morcellation. In general, if you can remove a uterus through the vagina or intact, that’s ideal because there’s a lot of data about the pros and cons from the vaginal approach to hysterectomy. But we’re not 100% certain that containment bags are going to be the “be-all and end-all.” In that, particularly if you’re doing subtotal hysterectomies, you still might be cutting through cancers and occult malignancies and the containment bags are very thin so that there’s a possibility that there could be leakage and/or breakage or unintended injury to other interperitoneal organs like bowels and vessels, etc. So we can’t be complacent about being 100% certain that things will go right even with the use of a bag.

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