MEMBER UPDATE #5: AAGL Response to FDA Guidance on Use of Power Morcellation during Tissue Extraction for Uterine Fibroids
Cypress, CA – Franklin D. Loffer, M.D., FACOG, Medical Director of the AAGL, released the following statement on behalf of the AAGL. It addresses the US Food and Drug Administration’s (FDA) Immediately-In-Effect guidance regarding power morcellators:
“The AAGL continues to sympathize deeply with those individuals who have been impacted by leiomyosarcoma and firmly stands behind our mission of serving women globally by advancing the safest and most efficacious diagnostic and therapeutic techniques that afford less invasive treatments for gynecologic conditions.
The AAGL supports the FDA’s recommendation for a boxed warning to provide enhanced informed consent, however, we are concerned with the summarization of contraindications in all peri- and post-menopausal women and we agree with the American College of Obstetrics and Gynecologists that additional clarification “regarding certain language within the contraindication that could be confusing to patients and physicians” is needed. Specifically, the following information needs to be clarified: a specific definition of peri-menopausal women; the role of power morcellation in the large group of reproductive-aged women who undergo myomectomy for fertility-sparing surgery; use of power morcellation in patients with non-fibroid uteri who may have refractory uterine bleeding, prolapse or adenomyosis; guidance regarding the use of containment bags; and guidance regarding the role of non-power morcellation (use of a manual cold knife scalpel in vaginal or mini-laparotomy tissue extraction).
At the 43rd AAGL Global Congress on Minimally Invasive Gynecology last week, the AAGL presented additional data concerning the prevalence of leiomyosarcoma at the time of morcellation, the outcomes associated with morcellation, and the comparative risk-to-benefit ratio when compared with laparotomy. The current international data are remarkably consistent and show a lower prevalence rate than the 1:350 rate reported by the FDA. There is also evidence that risk can be stratified by age and we will continue to provide data and consultation to the FDA. AAGL also believes that contained morcellation requires further exploration.
As demonstrated at a live presentation of different routes of morcellation, placing the tissue to be extracted into endobags appears to minimize the risk of dispersing tissue throughout the peritoneal cavity.
Going forward, the AAGL is committed to establishing a universal data registry for uterine cancers. Additionally, collaboration with medical device manufacturers is needed to ensure progressive advancement in technology, thereby providing patients with the safest, least invasive treatments possible.
In summary, abandoning power morcellation technology for many patients undergoing minimally invasive myomectomy, supracervical hysterectomy, or hysterectomy for a large uterus will be a setback in the care of patients with gynecologic conditions.
With meticulous adherence to preoperative patient selection guidelines and informed consent, the AAGL believes appropriately performed power morcellation outweighs the risk of laparotomy in low-risk patients and is an option to be carefully considered by patients and their gynecologists.”