In April 2014, the U.S. Food and Drug Administration issued a safety communication notice discouraging physicians from using laparoscopic power morcellation during hysterectomy surgery as well as uterine fibroid surgery (myomectomy), due to morcellation risks.

This safety communication was issued because the FDA determined that women were placed at greater risk for having their undetected uterine cancer unintentionally spread by the use of the device.

It was estimated that approximately one in 350 women who were to undergo hysterectomy or myomectomy would be at risk for spreading their previously undiagnosed uterine cancer.

The power morcellator is a medical device that is used during minimally invasive laparoscopic surgery.

Tiny incisions are made in the body during a laparoscopic surgery, and power morcellator devices were used to assist in hysterectomy and myomectomy surgeries. The device shreds the tissue and allows it to be removed through the small surgical openings in the body.

Power morcellation became very popular with physicians and patients alike because of the minimally invasive nature of the surgery. Traditional surgery performed necessitated a more invasive approach and resulted in longer recovery time.

Given the choice, women and their doctors naturally chose the less invasive procedure with a shorter recovery time, but many didn’t know about the risk of spreading undetected cancer.

Following the FDA’s safety communication discouraging the use of the device due to morcellation risks, Johnson & Johnson, the largest manufacturer of power morcellators, removed its medical device from the market.

Many hospitals stopped using power morcellators altogether and insurance companies began denying coverage for surgeries performed using the device because of the serious morcellation risks associated with its use.

Despite the morcellation risks, a company is looking to bring back the power morcellator back into favor by its creation of a new technology designed to support the use of power morcellation and reduce the associated risks.

Manufacturer Olympus has designed a device called the called the Olympus Contained Tissue Extraction System which contains a device known as the PneumoLiner.

The PneumoLiner is essentially a bag designed to collect the morcellator and tissue from the body. It is hoped that by containing any potentially cancerous tissue within the bag, any undetected cancer will not be spread during the surgical procedure using power morcellation.

The bag itself is made from sturdy materials designed to withstand forces greater than those generated by the power morcellator. It is impermeable to cells and liquids, but allows the surgeon to have the appropriate visual field to properly perform the surgical procedure.

Although it is designed to prevent morcellation risks of spreading undetected cancer, the PneumoLiner is contraindicated in patients who have known or suspected cancer.

It is also contraindicated for removing uterine tissue on peri-or post-menopausal women as well as for women who are more appropriately suited to mini-laparotomy or vaginal en bloc tissue removal.

The FDA cleared the device in April and the PneumoLiner was recently unveiled in Orlando, Florida during the annual meeting of the American Association of Gynecologic Laparoscopists (AAGL).