When a woman elects to use power morcellation during a needed hysterectomy or myomectomy, she may be putting herself at risk for aggressive cancer.

However, a new power morcellator device by maker Olympus may not be as risky as previous models.

In November 2016, Olympus announced it received a Food and Drug Administration 510(k) approval for a new power morcellator device.

The FDA 510(k) is a premarket submission to demonstrate that the device to be marketed is at least safe and effective. It does this by comparing the device to an already legally marketed device.

Olympus won the approval for its laparoscopic PK morcellator with tissue containment.

New Power Morcellator Device vs. Older Models

A power morcellator is a removal device for tissue such as fibroids or the uterus in the case of a hysterectomy. They have been promoted as more effective and requiring less recovery time than earlier procedures.

However, experts claim that women with undetected uterine sarcoma can be put at risk for aggressive cancer. The power morcellator device ruptures the uterine wall and can spread cancer cells throughout the abdomen.

It is estimated that 1 in 350 women who undergo power morcellation procedures may have undiagnosed sarcoma and are at risk of developing leiomysarcoma.

The new power morcellator device by Olympus includes the proprietary PneumoLiner contained tissue extraction system.

Dr. Arnold Advincula of Sloane’s Women’s Hospital said recently in a press release, “Contained tissue extraction is continually evolving. As surgeons, it is our duty to evaluate potential solutions to the surgical challenges we face in clinical practice.”

“We are pleased that Olympus has taken the initiative to develop a unique and well tested system designed specifically to facilitate the option for a laparoscopic approach in women who are at a low risk of having an unexpected malignancy at the time of surgery,” Dr. Advincula said regarding Olympus’ new power morcellator device.

Olympus mentioned that the new device should not be used if a woman who is peri- or post-menopausal has suspected uterine fibroids. They also warned against use in patients for en bloc tissue removal vaginally or via mini laparotomy.

The new power morcellator device is also not suggested for use in women with known malignancies.

Even though Olympus is hopeful about their new power morcellator device, power morcellators have been the subject of controversy. Earlier this year, maker Johnson & Johnson looked to settle hundreds of product liability and wrongful death lawsuits brought over now-recalled power morcellators.

Additionally, in April 2014 the US Food and Drug Administration issued a warning about power morcellators and conducted a special advisory panel to consider discontinuing their use.

In November 2014, the FDA issued black box warnings for all power morcellator devices.