Medical landscape ‘continuing to evolve’ after FDA guidance about power morcellation

The FDA issued guidance last fall about the use of laparoscopic power morcellation for treatment of uterine fibroids.

The agency warned against use of the technique during most myomectomies and hysterectomies due to the potential that it could spread undetected uterine sarcomas.

Jubilee Brown

“[Since then], things are continuing to evolve in the medical landscape, and practitioners and industry are all looking into how to make this procedure safer for patients within the guidelines that the FDA has established,” Jubilee Brown, MD, associate professor in the department of gynecologic oncology and reproductive medicine at The University of Texas MD Anderson Cancer Center, said in an interview.

HemOnc Today spoke with several experts to assess what has changed since the FDA issued its guidance, and how the clinical and research communities have responded to the warning.

New approaches

During power morcellation, a tiny instrument with a rapidly rotating blade grinds up uterine fibroids — or benign tumors within the uterus — and allows for their removal via a laparoscope.

The procedure allows for a smaller incision, quicker recovery period, fewer side effects and lower rate of morbidity than more invasive open surgeries.

In November 2014, the FDA issued “immediately in effect” guidance that warned against the use of power morcellators in hysterectomies and myomectomies.

The FDA estimated that approximately 1 in 352 women who undergo hysterectomy or myomectomy for presumed benign fibroids has an unsuspected uterine cancer, and that 1 in 498 has an unsuspected leiomyosarcoma. Other research, however, has questioned whether risks are that high, particularly for myomectomy.

In its guidance, the FDA recommended manufacturers of laparoscopic power morcellators include a boxed warning to acknowledge the risk that undetected leiomyosarcomas or other malignancies within uterine tissue can be disseminated throughout a woman’s pelvic and abdominal cavities during morcellation, increasing risks for morbidity and mortality.

The guidance also recommends morcellators be contraindicated for women who are peri- or postmenopausal, those who are candidates for en bloc tissue removal through the vagina or mini-laparotomy incision, and patients in whom the tissue to be morcellated is known or suspected to be cancerous.

Shortly after the FDA issued the guidance, Johnson & Johnson — a leading manufacturer of power morcellators — removed its products off the market. Several large institutions, including Brigham & Women’s Hospital and Cleveland Clinic, stopped performing laparoscopic power morcellation.

“Most organizations are limiting morcellation … and there are only a few morcellators on the market now,” David Mutch, MD, professor of obstetrics and gynecology and division chief of gynecologic oncology at Washington University School of Medicine in St. Louis, told HemOnc Today. “Use of the power morcellator has declined without question, and I think this is the right way to go.”

Despite its recommendation for a black box warning and contraindications, the FDA did not ban the procedure. Consequently, investigations into alternative means of performing power morcellation are underway.

“In order to continue with minimally invasive surgery and all of the benefits that it entails for our patients, we are looking at safer ways to accomplish the procedure,” Brown said. “Part of this is patient selection, and part of this is improving upon the devices that we already have available.”

Several companies also are looking at new devices that safely accomplish this, Brown said.

“There is still great interest in trying to understand if there are cases where the morcellator is beneficial, and there is ongoing research examining other tissue extraction methods, such as placing the uterus in a bag and morcellating within the bag, Jason D. Wright, MD, chief of the division of gynecologic oncology and associate professor of obstetrics and gynecology at Columbia University Medical Center, told HemOnc Today.

Jason D. Wright

Researchers at Washington University conducted a study to assess this alternative technique, known as contained morcellation. The data are expected to be published in Obstetrics & Gynecology, Mutch said.

“Even if the use of power morcellation comes back, informed consent from the patient is needed, which is something we were not doing much of before,” Mutch said.

Impact on payers

Although the FDA did not ban power morcellation, several hospitals and health care systems across the country stopped performing the procedure and many insurance companies have restricted coverage.

In May, Aetna implemented a new policy on the use of power morcellation for the removal of uterine fibroids. Myomectomy and hysterectomy procedures that use a power morcellator are no longer covered for most circumstances.

Although the reactions Aetna received from physicians are mostly supportive, Aetna has a process that allows for consideration of clinical exceptions in cases when physicians believe power morcellation is the best option for patients, according to B. Kathy Skipper, senior communications consultant for health and wellness with Aetna.

“Aetna requires doctors to precertify myomectomies or hysterectomies that use a power morcellator,” Skipper told HemOnc Today. “The policy takes into account the latest FDA warnings about the risk that morcellation can spread unsuspected uterine sarcoma in the abdomen and pelvis. Aetna is encouraging physicians to talk to patients about the risks and benefits of morcellation and the alternatives.”

Other insurance companies have not changed their policies. Health Care Service of America Corp. announced in June it will continue to cover power morcellation.

“I know that certain health insurance companies have made statements saying they will not cover hysterectomies that include morcellation,” Wright said. “I also know there are several insurers that are still reviewing the procedure and technology and continue to cover it. [The FDA’s guidance] has definitely impacted payers, and we will probably see more [changes] within the next few months.” – by Jennifer Southall

For more information:

Jubilee Brown, MD, can be reached at jbbrown@mdanderson.org.

David Mutch, MD, can be reached at mutchd@wudosis.wustl.edu.

B. Kathy Skipper can be reached at skipperb@aetna.com.

Jason D. Wright, MD, can be reached at jw2459@cumc.columbia.edu.