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What is Morcellation?
Morcellation is a surgical process in which tissue is divided up into small pieces and removed from the body. This procedure allows the surgeon to remove fairly large amounts of tissue through a relatively small incision.
The Dangers of Morcellation
In April of 2014 the FDA released a statement discouraging the use of power morcellation in hysterectomy surgeries for women with uterine fibroids (abnormal growths), as this technique may spread cancerous tissue. Power morcellator cancer should be a concern for all patients who underwent a hysterectomy, myomectomy, or uterine fibroid removal surgery.
In addition to cancer-related dangers, morcellation may permit the spread of non-cancerous cells to other parts of the abdomen where they can adhere to other tissues and cause complications.
Studies on Morcellators and Cancer
Two medical studies have linked the use of Morcellator use during hysterectomies to the spread of uterine cancer.
Uterine Pathology in Women Undergoing Minimally Invasive Hysterectomy Using Morcellation
Wright et al, 2014: Approximately one in 368 women who underwent hysterectomy using morcellation between 2006 and 2012 developed uterine cancer.
Quantitative Assessment of Risks of Uterine Power Morcellation
In July 2014, Christopher M. Jones presented a meta-analysis (a summary of current studies) regarding morcellator risks to the FDA at a meeting with their Obstetrics and Gynecology Devices panel.
Current Risks of Using a Power Morcellator
- One in 352 women undergoing hysterectomy or myomectomy for presumed fibroids have an unsuspected uterine sarcoma
- One in 498 women undergoing the same surgeries have an unsuspected uterine leiomyosarcoma (cancer originating from uterine fibroids)
- The spread or advancement of cancer in women following morcellation of an unsuspected sarcoma occurs in 25-64% of these cases
FDA Warnings and Power Morcellator Recalls
Because of the increased cancer risk associated with morcellator use, the FDA released multiple warnings in 2014 encouraging medical professionals to halt the use of these devices 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 since that time.
Victims Begin Filing Power Morcellator Lawsuits
One of the first 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. 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 due to the spread of cancerous tissue during her surgery.
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