
Johnson & Johnson has suspended sales of laparoscopic power morcellators in response to cancer concerns and a recent announcement by the U.S. Food and Drug Administration (FDA).
Laparoscopic surgery is a type of surgery where surgeons use very small incisions and small, specialized tools to perform most of the surgery within the patient’s body. This can greatly reduce recovery time. However, it’s been alleged that one specific type of laparoscopic surgery, morcellation, could encourage the spread of certain types of cancer.
Morcellation is the process of cutting apart tissue during laparoscopic surgery. This process is used to cut tissue into smaller pieces so it can be removed through the small cuts used in laparoscopic surgery.
However, it is alleged that this process can sometimes “free” cancer cells that are bound up in other tissues, making it easier for them to rapidly spread. For example, morcellation of uterine tissues may sometimes liberate a type of cancer called leiomyosarcoma (LMS). In this context, liberate means that it could make it easier for cancer cells to “escape” from their points of origin and spread throughout the body.
In response to these concerns, the FDA released a Safety Communication in April 2014. The FDA statement warned of the possible risk of liberating cancerous tumors during laparoscopic hysterectomies. The FDA has stated that it is gathering their advisors to discuss the issues and consider a boxed warning. The FDA will continue to evaluate their data. In the meantime, the statement strongly encouraged women to talk to their physicians about other options.
The FDA’s statement led Johnson & Johnson, a major manufacturer of laparoscopic surgery tools, to suspend the sales of their power morcellators. According to statements by the company, they have decided to hold off on morcellator sales until the role of morcellation in cancer is better understood.
Johnson & Johnson informed their customers on April 29 about the suspension of sales. The suspension involved three different models of morcellators, including the Morcellex Sigma Tissue Morcellator System, the Gynecare Morcellex Tissue Morecellator, and the Gynecare X-Tract Tissue Morcellator. Johnson & Johnson also stated that the warnings for their power morcellators always included warnings about these risks of spreading uterine tumors throughout the body.
A morcellation class action lawsuit investigation has been launched to explore the possibility of legal action against Johnson & Johnson over the morcellation issues. Group lawsuits of these type may allege that Johnson & Johnson was aware—or reasonably should have been aware—of the risks associated with the device. Such a morcellation lawsuit may further allege that the manufacturers downplayed the risks, endangering patients. Such a case may seek to recoup the cost of medical care, lost wages, and legal costs.
In general, morcellator cancer lawsuits are filed individually by each plaintiff and are not class actions.
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If you or a loved one were diagnosed with cancer in the uterus, pelvis or abdomen within two years of undergoing surgery for a myomectomy (removal of fibroids), hysterectomy (removal of the uterus), oophorectomy (removal of the ovaries), or salpingectomy (removal of fallopian tubes), you may have a legal claim. See if you qualify by filling out the short form below.
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