May 7, 2014 — The first lawsuit has been filed against LiNA Medical, manufacturer of the LiNA Xcise laparoscopic power morcellator, alleging that the company failed to adequately warn about the risk of spreading aggressive cancer when the tool is used in hysterectomy or fibroid-removal surgery.
The plaintiff, Donna Burkhart from Reading, Pennsylvania, had a hysterectomy in March 2012 and a morcellator was used. She was not warned about the risk of seeding her abdominal cavity with an undiagnosed sarcoma cancer. She died less than a year later in February 2013 of metastatic leiomyosarcoma.
Another lawsuit has been filed against Ethicon Endo Surgery, Inc., on behalf of plaintiff Brenda Leuzzi. In September 2012, she underwent robot-assisted fibroid surgery using a morcellator. She says she was promised a minimally-invasive procedure with a short recovery, but said “It was the biggest mistake of my life.”
Leuzzi is currently undergoing chemotherapy and radiation therapy for a rare form of uterine cancer that doctors cannot currently get into remission. According to the complaint:
“Early investigations into the actions of Ethicon Endo Surgery indicate that there was knowledge of this issue relating to dissemination of cancer and that potential safety solutions including the deployment of a ballistic reinforced bag to avoid spillage of unsuspected cancer cells were available to the company but were not provided as part of the product sold to hospitals.”
Many hospitals are responding to complaints by restricting the use of power morcellators to a contaminant bag, which reduces the risk of spreading undiagnosed cancer in a patient’s abdomen. About 1 in 350 women who undergo surgery to remove fibroids actually has cancer. Morcellators do not cause cancer, but the technique can worsen cancer by spreading cancerous cells throughout a woman’s pelvis and abdomen. By the time a patient is diagnosed, it is usually very difficult to treat.
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