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FDA Recalls
Power Morcellator
Dangers of Power Morcellator Cancer
Morcellation Hysterectomy Surgeries
Morcellator Lawsuit
FDA Morcellator Recall
Due to the FDA morcellator recall that linked the spread of cancer to power morcellators, most manufacturers have stopped their production and distribution. The FDA and these manufacturing companies are now facing lawsuits as patients are coming forward with complications. Patients are claiming that they were not properly warned of these risks.
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What is a Morcellator and What Does it Do
A power morcellator is an electrical tool used in laparoscopic surgery to remove a portion of tissue. This tool functions by cutting away small portions of tissue that can afterward be removed through an incision. Power morcellators are most commonly known for their use in surgical removal of uterine fibroids (myomectomy), or in some cases, removal of the entire uterus (hysterectomy).
Morcellator Recall
Power morcellators were first introduced to the market in 1993. As of 2014, however, research has come to light demonstrating increased cancer risk in some individuals with their use. Because of this risk, the FDA released multiple warnings in 2014 encouraging medical professionals to halt the use of power morcellators in the removal of uterine fibroids. Johnson & Johnson subsequently halted sales and distribution of power morcellators, and has issued a recall on three different models of the device.
Power Morcellator Lawsuit
One of the first patient cases to gain publicity was that of Barbara Leary, a woman who underwent what was supposed to be a routine surgery to remove uterine fibroids only to pass away 54 months later from stage 4 cancer in September of 2009. Similarly, Brenda Leuzzi was assured by her doctors that she was cancer free prior to surgical removal of uterine fibroids, but in the months following it was discovered that she had developed stage 4 cancer as well due to the spread of cancerous tissue during her surgery. Brenda Leuzzi passed away in October of 2014, just months after the FDA released their initial warning in April.
The families of Barbara Leary and Brenda Leuzzi testified in the FDA hearings leading to the 2014 morcellator recall. As a result of their experiences and those of many other individuals like them, lawsuits have been filed based in part on the following complaints:
Failure to warn of risks and complications associated with morcellation
Production and distribution of a product that is unsafe and unfit for its intended use
Lack of proper safety testing prior to releasing the product to market
Failure to remove the product from the market once health risks were known
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