June 3, 2014 — Johnson & Johnson was warned about the risks of their power morcellator device spreading uterine cancer as early as 2006, according to an exclusive report from the Pittsburgh Business Times.
Those warnings came eight years before the company stopped selling the devices. Earlier this year, the U.S. Food and Drug Administration (FDA) warned that power morcellators should not be used in hysterectomies due to the risk of uterine cancer, including leiomyosarcoma (LMS).
Dr. Robert Lamparter, a pathologist at Evangelical Community Hospital in Pennsylvania, says he asked the company to “reconsider the risk to the patient.” He stated:
“When the operative procedure is a standard hysterectomy, no damage is done. If a morcellation is done, the patient’s survival is jeopardized.”
Dr. David Robinson, medical director of Ethicon Women’s Health and Urology at the time, told Lamparter that they would add a warning to the instructions. Last week, the company told the Pittsburg Business Times that morcellators have “always included cautions in the instructions for use about the potential spread of malignant or suspected malignant tissues.”
Many doctors and patients say they were not aware of the risk of spreading undiagnosed uterine cancer until April, when the FDA published a warning. The agency estimated that 1-in-350 women who have a hysterectomy to remove fibroids actually has undiagnosed cancer. If a morcellator is used in the procedure, it can potentially leave behind cancerous cells and “seed” aggressive sarcoma throughout a woman’s pelvis and abdomen.
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