Third Power Morcellator Lawsuit Filed In Philadelphia

A woman in a Philadelphia county has filed the third Pennsylvania lawsuit against the manufacturing company Olympus.

A woman in a Philadelphia county has filed the third Pennsylvania lawsuit against the manufacturing company Olympus.
On Friday, September 11th, a manufacturing company named Olympus was hit with a new lawsuit. The lawsuit alleges that the power morcellator manufactured by Olympus called the PKS PlasmaSORD Bipolar Morcellator spread the uterine cancer of a Philadelphia woman.

power morcellator surgery
This complaint is the third filed in Pennsylvania against this company. Each case claims the same thing – that the company knew, or should have known that the use of a power morcellator during a gynecological surgery had the potential to spread undetected uterine cancer.

A Look Back At The Power Morcellator

The power morcellator was first approved by the U.S. Food and Drug Administration several decades ago under a 501(k). Manufacturers were able to forgo the usual safety testing and clinical trials that are required of new surgical tools, because the 501(k) allows devices that are “substantially equivalent” to previously approved devices to bypass the testing.

The morcellator is widely used in laparoscopic surgeries. It is inserted into the body cavity via small incisions, where it uses cutting jaws to saw through the offending tissue intended for removal. The tissue is then pulled through the hollow tube of the morcellator so that the initial incision does not need to be widened.

In women, the device is often used to perform hysterectomies and myomectomies. These surgeries are often the recommended course of treatment for uterine fibroids. While most uterine fibroids are benign, there is currently no reliable testing method to determine if the fibroid contains uterine cancer. If a morcellator cuts through a fibroid containing uterine cancer, there is a chance that the cutting jaws will disseminate the cancer cells throughout the body cavity.

After several decades, the FDA acknowledged this risk and published a safety warning for the medical community and the public. The warning stated that “Based on an FDA analysis of currently available data, we estimate that approximately 1 in 350 women undergoing hysterectomy or myomectomy for the treatment of fibroids is found to have an unsuspected uterine sarcoma, a type of uterine cancer that includes leiomyosarcoma.”

It further stated that “ If laparoscopic power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s long-term survival.” and “Because of this risk and the availability of alternative surgical options for most women, the FDA is warning against the use of laparoscopic power morcellators in the majority of women undergoing myomectomy or hysterectomy for treatment of fibroids.”

After being slammed with numerous lawsuits, Johnson and Johnson voluntarily withdrew all of its available power morcellators from the market in 2014. Other manufacturers have gone in a different direction, threatening legal action against those who speak out against the use of their power morcellators.

About Laurence Banville

Attorney Contributor:

Laurence P. Banville, Esq. is the managing partner of Banville Law. He is a regular contributor on several topics including negligent security cases, child sexual abuse and Dram Shop and liquor liability cases.

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