May 30, 2014 — A growing number of women are filing lawsuits against manufacturers of power morcellators for failing to adequately warn doctors and patients that the device can potentially spread undiagnosed cancer throughout a woman’s pelvis and abdomen, greatly reducing her chances of long-term survival.
One of the most recent lawsuits was filed on May 7 by Peggy Padula, a woman from Florida. She was treated with a power morcellator during a hysterectomy in April 2013 at the Cleveland Clinic.
During the procedure, a power morcellator was used to cut, shred, and remove fibroids from her uterus. Afterward, she was diagnosed with endometrial stroma sarcoma that began in her uterus but spread throughout her abdominal cavity after the procedure.
According to her complaint:
“The Defendants failed to adequately warn about the true risk of dissemination and fulmination of cancer from the use of the Storz Morcellator. Despite their knowledge of that true risk and of their own failure to adequately warn of it, they failed to make the instrument safe for its intended use, making it unsafe for that use.”
The FDA recommended against using power morcellators in hysterectomies in April. Before this time, many women were never informed about the risk of cancer. The Wall Street Journal recently highlighted the story of one woman, Debra Grymkoski, who only learned about the controversy after reading about it in the WSJ.
That article may have saved her life. She voiced her concerns to her doctor, who agreed not to use a power morcellator despite his own belief that the risk of cancer was negligible. After her uterus was removed vaginally, she was diagnosed with a type of uterine sarcoma called an endometrial stromal sarcoma. Had she undergone a hysterectomy using a power morcellator, it might have spread cancer-causing cells throughout her body. She is currently cancer-free.
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