Power Morcellator Lawsuit Information


 

Federal health regulators have warned that power morcellators, a type of surgical tool used in laparoscopic hysterectomies and fibroid removal procedures, may promote the spread of a rare, but often deadly, form of uterine cancer. In response, Ethicon Inc., a unit of Johnson & Johnson, has suspended the sales of several of its power morcellators. A number of hospitals have also temporarily banned morcellation until this potential risk can be more fully evaluated.

Ethicon and other morcellator manufacturers have already been named in at least one power morcellator lawsuit alleging the use of the devices can promote the spread of uterine sarcoma. The nationwide law firm of Bernstein Liebhard LLP is now investigating hysterectomy cancer lawsuits on behalf of other women whose cancer may have been spread by a power morcellator. If you would like to explore your legal options, please contact our Firm today to learn more about the process for filing your own power morcellator lawsuit

FDA Hysterectomy Morcellator Cancer Warning

Power morcellators use long, tube-shaped blades to cut uterine tissue into small pieces. This allows a surgeon performing a laparoscopic, or minimally invasive, hysterectomy, to remove the tissue through a small incision. Morcellator hysterectomies have grown in popularity in recent years, as these procedures allow patients to avoid open abdominal surgeries that can result in large scars and longer recoveries. Power morcellators are also frequently used to remove uterine fibroids in a procedure known as myomectomy.

On April 17, 2014, the U.S. Food & Drug Administration (FDA) issued a safety alert to discourage the use of power morcellators in women undergoing hysterectomies and myomectomies to remove fibroids. According to the alert, power morcellation poses a risk of spreading undetected cancerous cells, notably uterine sarcomas, beyond the uterus. The alert noted that 1 in 350 women undergoing hysterectomy or myomectomy for fibroids is found to have an unsuspected uterine sarcoma, and that the spread of this cancerous tissue into the abdomen and pelvis can significantly reduce a patient’s chances of long-term survival. According to the alert, the FDA planned to convene an advisory panel meeting during the summer of 2014 to further investigate the cancer risks potentially associated with power morcellation.

According to a report from The Wall Street Journal, the potential link between power morcellation and cancer was the subject of considerable concern even before the FDA issued its alert. In the wake of the advisory, the Cleveland Clinic and Boston’s Brigham and Women’s Hospital were among several facilities that announced a suspension of morcellator procedures pending further guidance from the FDA.

Morcellator Cancer Risk Prompts Ethicon Sales Suspension

The risks detailed in the FDA alert prompted Johnson & Johnson’s Ethicon unit to halt world-wide sales, distribution and promotion of its power morcellators, including the:

  • Gynecare Morcellex Tissue Morcellator
  • Morcellex Sigma Tissue Morcellator System
  • Gynecare X-Tract Tissue Morcellator

It is important to note that Ethicon’s announcement does not constitute a morcellator recall, and will not prevent doctors from using devices already in hospital inventories. Despite its decision to end sales of Ethicon’s power morcellators, Johnson & Johnson said in a statement that it remains confident that the devices are safe and effective. According to the company, it is waiting for the FDA to provide further clarification regarding the use of power morcellation in fibroid surgeries.

Even before the company announced the sales suspension, a Gynecare morcellator lawsuit had been filed in Pennsylvania federal court that accused Ethicon of failing to warn that power morcellation could result in the spread of undiagnosed cancer outside of the uterus. The complaint, which also names other morcellator manufacturers as defendants, was filed in March 2014 on behalf of a 53-year-old woman who died from metastatic leiomyosarcoma less than a year after undergoing a morcellator hysterectomy.

Learn More about Filing a Power Morcellator Lawsuit

You may be entitled to file a hysterectomy cancer lawsuit if you or a loved one were diagnosed with uterine sarcoma, leiomyosarcoma, or any other cancer that may have been spread during a hysterectomy or myomectomy that involved the use of a morcellator. To learn more about the legal process for filing a power morcellator lawsuit, please give Bernstein Liebhard LLP a call today, at , for a free, no-obligation review of your case.