More than 20 years after the first power morcellation devices entered the market, the FDA approved the first morcellation containment system in April 2016.

However, a recent study about the effectiveness of the Pneumoliner morcellation containment system has prompted the FDA to issue a cautionery warning about the system.

Specifically, the FDA warns that the morcellation containment systems have not been proven to reduce the risk of disseminating power morcellator cancer and should only be used in a limited number of laparoscopic gynecological surgery cases.

Study Cautions On Morcellation Containment System Use

According to a study published in the May issue of JAMA, the new morcellation containment system designed to isolate uterine tissue during hysterectomies and uterine fibroid removal during surgeries with a power morecellator has not been proven to reduce the risk of spreading cancerous tissue.

The study alerted medical professionals that while the PneumoLiner morcellation containment system effectively contains morcellated tissue, the manufacturer, Advanced Surgical Concepts, must warn clinicians and patients that there is still a risk of cancer spread when the morcellation containment system is used.

“This new device does not change our position on the risks associated with power morcellation,” said William Maisel, MD, MPH, of the FDA’s Center for Devices and Radiological Health. “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.”

The FDA ordered that manufacturers of power morcellators put a black box warning on the devices after researchers determined that the procedure could spread undetected uterine cancer, making the disease more difficult to treat.

Power morcellators are devices fitted with a tube-like blade that minces uterine growths or entire uteruses within the abdominal cavity and removes the tissue through an incision in the abdomen.

The PneumoLiner consists of a containment bag and a tube-like plunger that positions it in the abdominal cavity. The tissue being removed is placed in the bag, which is sealed and inflated. Then, surgeons morcellate the tissue inside the bag.

The FDA also placed a similar “Black Box” warning on the PneumoLiner morcellation containment system that appears on power morcellators.

Power Morcellation Dangers

Power morcellation devices are surgical tools that are used during fibroid surgery and hysterectomies to grind up uterine tissue into pieces that can be removed through small incisions. In the past, hand-operated morcellation devices were almost always used with surgical bags.

When power morcellators hit the market in the 1990s, the bags were rarely used because they were cumbersome and most surgeons though the risk of spreading power morcellator cancer was low.

That all changed two years ago, when the FDA warned that 1 in 350 women undergoing a hysterectomy or fibroid surgery actually has undiagnosed uterine sarcoma, and 1 in 500 has highly-aggressive leiomyosarcoma.

The problem is that morcellators often leave behind tiny pieces of tissue. If the pieces contain cancerous cells, morcellators can spread aggressive power morcellator cancer throughout a woman’s abdomen and significantly increase her risk of death.

If you or a loved one developed cancer or passed away after undergoing morcellation surgery, you may be eligible to file a power morcellator lawsuit or a wrongful death lawsuit against the device manufacturer.