Power Morcellator Manufacturer Slammed With Another LawsuitA new lawsuit has been filed in Florida by a women who claims a morcellator spread her undetected uterine cancer. On May 7th, 2014, a Florida woman filed a lawsuit in the U.S. District Court for the Southern District of Florida under case number 14-cv-61086 against power morcellator manufacturing company, Karl Storz Endovision, Inc.
Her complaint alleges that when she underwent a supracervical hysterectomy on April 8th, 2013, the morcellator used during her surgery spread her previously undetected uterine cancer. She has stated that prior to having surgery, pre-anesthetic testing was performed which did not give any indication that she had cancer. Following the procedure, she was informed that pathologists had found endometrial stromal sarcoma contained within a uterine fibroid.
The Complaints Against MorcellatorsHer lawsuit is not unique; at this time more than 30 women have filed complaints against numerous morcellator manufacturers including Karl Storz Endovision Inc, Richard Wolf GmbH, Gyrus ACMI, and Ethicon, a Johnson & Johnson subdivision. Each suit alleges that a morcellator disseminated undiagnosed uterine cancer throughout the body cavity when used during gynecological surgery.
History Of The MorcellatorThe morcellator was first approved for use under the U.S. Food and Drug Administration's 501(k). This process allows companies to forgo any safety testing if they can show that their tool is “substantially equivalent” to a previously approved tool. Surgeons began using the surgical instrument in a wide variety of surgeries, including hysterectomies and myomectomies.
Hysterectomies and myomectomies are typically performed when the patient is suffering from uterine fibroids. Fibroids can grow so large that they cause abnormal bleeding and pain. Doctors used to believe that fibroids were benign, but recently, the FDA announced that they believed 1 in 350 women undergoing a gynecological procedure to remove fibroids also have undetected uterine cancer. They then issued a safety warning indicating that doctors should reconsider the use of the morcellator on women with fibroids due to this significant risk.
Response From ManufacturersSeveral manufacturing companies have responded to the FDA’s safety warning and the pending lawsuits. Ethicon decided to voluntarily withdraw all of their power morcellators from the market and sent letters to doctors around the globe requesting that they return the device. At this time, they are the only company that has stopped producing and selling the morcellator.
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