Colorado Woman Files Power Morcellator Lawsuit Against Ethicon
Latest Power Morcellator Lawsuit Filed In Colorado
Ethicon, a company facing numerous power morcellator lawsuits, is named as the defendant in the newest power morcellator lawsuit.Ethicon has once again been sued by a woman who alleges that a power morcellator they manufactured spread her undetected uterine cancer.
Ethicon: A Subdivision Of Johnson & Johnson
Ethicon was one of the first companies to manufacture power morcellators after the surgical instrument was first introduced to the United States in the early 90’s. The morcellator was immediately embraced by the medical community because of its ability to be used in laparoscopic surgeries. The tool is inserted into the abdomen through a tiny incision where it cuts through tissue and allows the surgeon to remove the tissue in smaller pieces.
Power Morcellators And Uterine Cancer
Power morcellators were approved by the U.S. Food and Drug Administration under a 501(k). The 501(k) allows devices to be approved without undergoing the usual safety testing if the company submitting for approval can show that the device is “substantially equivalent” to a previously approved tool.
Recently, the FDA released a safety communication to the medical community and the public, stating that the use of a power morcellator during gynecological surgeries may spread undetected uterine cancer to other areas of the body cavity. In many cases, women undergo hysterectomies and myomectomies to treat uterine fibroids. These fibroids were thought to be typically benign, however, the FDA now estimates that 1 in 350 women undergoing these procedures has undiagnosed uterine cancer.
The Colorado Lawsuit
In this latest case, the plaintiff underwent a laparoscopic procedure where the surgeon used a Dive LPM made by Ethicon. She had the surgery on April 4th, 2013, and was told soon after, that one of her fibroids contained leiomyosarcoma.
Following this diagnosis, she has been treated with aggressive chemotherapy and radiation which has been painful and disabling.
Her complaint states that, “Although evidence was available to the defendants for years before the plaintiff’s surgery, the defendants failed to respond to multiple published studies and reports describing the risk of disseminated and upstaging or worsening occult cancer. They failed to design their LPM products, including the Diva, in a manner to reduce this life-threatening risk.”
The lawsuit is just one of many filed by either a woman who underwent a gynecological surgery where undetected uterine cancer was allegedly spread or the family of a woman who passed away from uterine cancer after a power morcellator was used.