By Dr. K. Anthony Shibley
Earlier this year, the FDA revised its guidance around the use of laparoscopic power morcellation to make it safer in gynecologic surgeries.
This updated guidance clarifies who is eligible for laparoscopic power morcellation and how the procedure should be performed. The lack of clarity associated with the FDA’s former black box warning on morcellators used to break up fibroid tissue has meant that, since 2014, most clinicians erred on the side of caution and did not recommend laparoscopic power morcellation for many patients due to the risk of spreading cancerous tissue throughout the body. For many patients, however, minimally invasive surgery using laparoscopic power morcellation and a containment system has a better safety profile than open surgery.
The FDA’s updated guidance pertaining to laparoscopic power morcellation is due in part to innovations in the procedure that make it safer for eligible patients. As patients become savvier advocates for their own care, this update empowers them to discuss with their clinicians an option that is associated with less pain, shorter hospital stays, less scarring, and less downtime.
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The updated FDA guidance is clear. Before, the FDA warned against all morcellation for perimenopausal women. Since the term “perimenopausal” is loosely defined, the guidance yielded too much uncertainty regarding the procedure and made many clinicians uncomfortable recommending a potentially risky option to their patients. Now, the guidance advises against the use of laparoscopic power morcellation in patients with fibroids who are either over 50 years old or post-menopausal. By clearly defining the category of people who are ineligible for laparoscopic power morcellation, the FDA has dispelled the uncertainty that prevented many clinicians from recommending the procedure since 2014.
Helpfully, the guidance also requires that all laparoscopic power morcellators be used with a compatible containment device. Although the risk of spreading cancer through laparoscopic power morcellation increases with age, particularly for those over age 50, the procedure is also associated with the spread of benign uterine tissue that may grow to become parasitic myomas or even cause the condition of disseminated peritoneal leiomyomatosis. Containment reduces this risk.
As a result of this updated guidance, clinicians can now confidently recommend to eligible patients an option that eliminates the risks associated with open surgery, including infection and long recovery times (Harris et al., 2016). In addition, patients are more likely to experience improved outcomes, such as a briefer length of stay, a quicker return to their normal routines and lower risk of a recurrence of fibroids. Overall, laparoscopic power morcellation with containment offers both eligible patients and surgeons peace of mind.