April 29, 2015 — Johnson & Johnson’s subsidiary Ethicon has been hit with a lawsuit on behalf of a woman who was diagnosed with uterine cancer after undergoing a medical procedure involving a Gynecare X-tract Tissue Morcellator.
The lawsuit (PDF) was filed on April 7 in the U.S. District Court for the Northern District of Georgia. The plaintiff, 86 year-old Eva Galambos, is an 86 year-old woman who was Mayor of Sandy Springs, Georgia from 2005-2013.
In January 2011, Galambos had a laparoscopic (“minimally-invasive”) hysterectomy to remove uterine fibroids. Before the surgery, she had no evidence of cancer and was never warned that the use of a power morcellator could spread cancer.
Galambos underwent treatment and thought she was cancer-free until April 2013, when the cancer returned in her pelvis and abdomen. According to the lawsuit:
“Had the Laparoscopic Power Morcellator used on Plaintiff not disseminated fulminated cancerous cells and tissue, she would not have suffered and been diagnosed with a recurrence of her endometrial stromal sarcoma.”
Power morcellators use spinning blades to shred tissue masses. During morcellation, fragments of cancerous tissue can be left behind in the abdominal cavity or attach to nearby organs. Cancerous cells can also travel to remote areas of the body through the blood or lymphatic system, greatly worsening the patient’s prognosis.
One year ago, the FDA warned that 1 in 350 women who undergoes a hysterectomy for fibroids actually has undiagnosed cancer. The FDA has been criticized for allowing the devices to remain on the market. The manufacturer of Galambos’ morcellator, Johnson & Johnson, voluntarily withdrew all products from the market in mid-2014.
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