July 11, 2014 — Richard Wolf Medical Instruments has been hit with a lawsuit (PDF) from a woman who developed highly-aggressive cancer after she was treated with a morcellator. The lawsuit was filed in May in the U.S. District Court for the Northern District of California.
The plaintiff, Sarah Salem-Robinson, had a supracervical hysterectomy in May 2012. During the procedure, a Wolf Power Morcellator was used to remove fibroids on her uterus.
Afterward, she was informed that one of the “fibroids” was actually a cancerous tumor — leiomyosarcoma (LMS). She was also informed that because the morcellator was used in her surgery, there was a significant risk that cancerous cells had spread within her abdomen.
She started undergoing surveillance imaging. Although initial scans of her lungs, abdomen, and pelvis did not show signs of cancer, she has subsequently developed four small lesions in one of her lungs that likely represent leiomyosarcoma.
According to the complaint:
“Because of the risk of metastatic disease, plaintiff has undergone and continues to undergo aggressive treatment and therapy that has caused plaintiff injury and severe pain and suffering.”
Wolf Medical is accused of failing to warn about the risk of disseminating uterine cancer or leiomyosarcoma throughout the peritoneal cavity.
In April 2014, the U.S. Food and Drug Administration (FDA) recommended against using morcellators for hysterectomies. The agency estimated that 1 in 350 women who has a hysterectomy for fibroids actually has undiagnosed uterine cancer, and 1 in 500 actually has leiomyosarcoma.
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