A surgical tool used in laparoscopic hysterectomies and fibroid removal surgeries has been suggested to cause an often deadly strand of uterine cancer to spread; an association that may prompt more power morcellator lawsuit claims to be filed on behalf of women and their families.
In response to a warning issued in April 2014 by the U.S. Food and Drug Administration (FDA) that discouraged the use of these devices, the Johnson & Johnson subsidiary, Ethicon ceased sales of several power morcellators. Several hospitals have also banned morcellation, a process by which the device cuts uterine tissue into small pieces using long, tube-like blades, pending further investigation from the FDA. In addition to devices manufactured by Ethicon, several other manufacturers have designed power morcellators on the market today.
The nationwide law firm of Bernstein Liebhard LLP is actively monitoring this research, and is evaluating morcellator lawsuit allegations on behalf of women whose cancer may have spread as a result of these tools. The cancer allegedly associated with the use of power morcellators is uterine sarcoma.
The FDA issued a public health alert to warn about the alleged dangers of morcellation on April 17, 2014, at which time the federal agency informed the public that 1 in 350 women undergoing fibroid removal may have undiagnosed uterine sarcoma. If a power morcellator is used during a hysterectomy or myomectomy to remove the fibroids, there is a risk that the surgical tool will spread the undetected cancerous cells to areas outside the uterus. The end result of this tissue spreading into the pelvis and abdomen may lead to a severely decreased likelihood of long-term survival. The FDA vowed to investigate the link between power morcellation and cancer in an advisory panel it planned to convene in the summer of 2014.
Since the FDA notice in April, Johnson & Johnson’s Ethicon has suspended sales of several products. The following power morcellators are currently not being sold, distributed or promoted, according to the company:
A Wall Street Journal report published in April notes that several facilities have suspended the use of power morcellators in fibroid removal and hysterectomy surgeries. Pending further research from the FDA, the Cleveland Clinic and Boston’s Brigham and Women’s Hospital have halted morcellation practices in their facilities, according to the report. The Gynecare Morcellex, Gynecare XTract and the Morcellex Sigma may have been included in hysterectomy and thyroid cancer procedures conducted in the above hospitals.
It is noteworthy to add that Ethicon’s suspension of these products does not translate to a morcellator recall. Doctors may still use power morcellators that have already been purchased by hospitals, which the company maintains are safe and effective for use. The Johnson & Johnson subsidiary is waiting for further FDA clarification on the use of power morcellators in fibroid removal surgeries, the company has said.
The attorneys at Bernstein Liebhard LLP note that a power morcellator lawsuit against Ethicon and other manufacturers has already been filed in Pennsylvania federal court. The complaint, which was filed a month before the FDA’s public health alert in April, accuses Ethicon of failing to adequately warn about the risk for its power morcellator to spread undiagnosed cancer outside the uterus, and into other parts of the body. The March 2014 lawsuit was brought on behalf of a 53-year old woman who underwent a morcellator-aided hysterectomy and died less than a year later from metastatic leiomyosarcoma.
If you or a loved one were diagnosed with uterine sarcoma, leiomyosarcoma, or another cancer after receiving a hysterectomy or myomectomy aided by a morcellator, you may be eligible to file a lawsuit. Call our Firm today at .