Two Philadelphia women are the latest to file power morcellator lawsuits alleging manufacturers should have warned that the medical device could spread undetected uterine cancer cells throughout the body.

Plaintiffs Betty D. and Anita W. are suing power morcellator manufacturers Olympus Corporation and its subsidiary Gyrus ACMI for misrepresenting their device as a “safe” option to use during hysterectomy or myomectomy procedures.

The plaintiffs allege that the manufacturers should have known, based on decades of studies, that using power morcellators during gynecological surgeries could spread uterine cancer tissues throughout the abdomen. Plaintiffs Betty and Anita claim Olympus failed to design a reasonably safe medical device.

What is a Power Morcellator?

Power morcellators were fast-tracked through the FDA approval process to be used in less invasive laparoscopic hysterectomy and myomectomy procedures. The medical device is used to break-up uterine fibroids into fragments for removal.

Use of a power morcellator for a hysterectomy meant a shorter post-op recovery time for women when compared to a more traditional abdominal surgery. However, recent studies show one in 350 women who undergo a hysterectomy or myomectomy procedure that involves using a power morcellator are eventually diagnosed with uterine sarcoma.

There’s no easy way to determine if uterine cancer tissues exist prior to surgery, so patients who have unsuspected uterine sarcoma are at a greater risk of having the cancer spread due to power morcellator use.

FDA “Black Box” Warning

Due to the growing evidence of power morcellator cancer risks, the FDA urged manufacturers to include a “black box” warning on all existing and new devices. This is the strongest caution before the FDA will remove the product from the market.

In a recent report, the FDA addressed power morcellator concerns by encouraging physicians and patients to limit the risks by taking the following actions:

• Patients: Should ask about different options available, and if a physician still recommends a laparoscopic hysterectomy or myomectomy, find out if he/she plans on using a power morcellator.
• Physicians: Should limit the power morcellator use by carefully considering “available alternative treatment options for the removal of symptomatic uterine fibroids.”

The FDA warnings encouraged Johnson & Johnson to pull their power morcellator devices off the market until more research determines the connection between the medical tool and its alleged role in spreading uterine cancer.

In addition to this action, the FDA warnings also prompted some of the largest health insurance companies in the U.S. to change the way they classify power morcellators, making it extremely difficult to get insurance coverage to use the medical device in hysterectomy procedures. Aetna Inc., Cigna, UnitedHealth Group Inc. and various others are choosing not to easily cover the cost of using the tool because of the FDA cancer risk warnings.

Morcellation Cancer Lawsuits

Hundreds of women and their families have filed power morcellator lawsuits, accusing manufacturers of downplaying the serious health risks associated with the medical device. Many morcellation lawsuits like the ones filed by plaintiffs Betty and Anita allege the manufacturers knew of the cancer risks but did not adequately warn patients.

If you developed uterine sarcoma after having a hysterectomy that used a power morcellator, you may be able to join a morcellation cancer class action lawsuit.

The Morcellation Cancer lawsuits are Case Nos.: 150401310 and 150401312, in the Philadelphia County Court of Common Pleas.