FDA allows marketing of PneumoLiner tissue-containment system for use during power morcellation

The FDA today permitted the marketing of PneumoLiner for use with certain laparoscopic power morcellators to isolate uterine tissue that is not suspected to contain cancer in a limited patient population.

PneumoLiner (Advanced Surgical Concepts) is intended to isolate and contain tissue considered to be noncancerous before surgery, even if that tissue is subsequently determined to be cancerous. The device consists of a containment bag and tube-like plunger that delivers the device to the abdominal cavity. Tissue is placed in the bag, which is then sealed and inflated to improve visualization during morcellation and help prevent breakage of the bag during the procedure.

This first-of-its-kind tissue-containment system is intended for use in a limited patient population, including women without uterine fibroids undergoing hysterectomy and some premenopausal women with fibroids who want to maintain their fertility.

“The PneumoLiner is intended to contain morcellated tissue in the very limited patient population for whom power morcellation may be an appropriate therapeutic option — and only if patients have been appropriately informed of the risks,” William Maisel, MD, MPH, deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health, said in a press release.

Risks associated with the device include dissemination of morcellated tissue, injury to surrounding tissues or organs, infections and a prolongation of the surgical procedure.

The FDA issued a warning in November 2014 about the use of laparoscopic power morcellators to treat uterine fibroids. The guidance warned against the use of morcellators in hysterectomies or myomectomies in the majority of women due to the potential that they can spread undetected uterine sarcomas.

Approximately one in every 350 women who undergo hysterectomy or myomectomy for fibroids has an unsuspected uterine sarcoma, according to the FDA. In these cases, morcellation may spread the cancerous tissue within the abdomen and pelvis, worsening the patient’s survival outcomes.

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 morbidity and mortality risks. The FDA also recommended product labeling include contraindications.

Soon after the announcement, several large institutions — including Cleveland Clinic and Brigham and Women’s Hospital — stopped performing laparoscopic power morcellation.

Yet surgeons and clinicians continue to debate whether the FDA intended for power morcellation to be abandoned entirely, or if the agency left its guidance vague intentionally to allow surgeons to perform the procedures in patients who provide informed consent.

The PneumoLiner must contain a boxed warning that alerts patients and physicians that laparoscopic power morcellators may spread unsuspected cancer during fibroid surgery. The tissue-containment system has not been shown to reduce this risk, according to the FDA.

Further, the device in contraindicated for use in surgeries where there is known or suspected malignancy, and for removal of uterine tissue in women who are peri- or postmenopausal or candidates for en bloc tissue removal.

According to the FDA, the required labeling for PneumoLiner also must state that use of the device is limited to physicians who have successfully completed the manufacturer’s validated training program.

“This new device does not change our position on the risks associated with power morcellation,” Maisel added. “We are continuing to warn against the use of power morcellators for the vast majority of women undergoing removal of the uterus or uterine fibroids.”