A recent study about morcellation published in the Journal of the American Medical Association (JAMA) has reinforced the U.S. Food and Drug Administration’s (FDA) April 2014 warning about a potentially deadly risk associated with morcellator devices used during hysterectomies and uterine fibroid removal.
The study, titled “Uterine Pathology in Women Undergoing Minimally Invasive Hysterectomy Using Morcellation,” showed that 27 in every 10,000 women undergoing a hysterectomy had cancerous tumors that can spread to other parts of the body during the morcellation process.
The JAMA study prompted an Ethicon morcellator recall from Johnson & Johnson (J&J) in July 2014. Three months prior to the recall, the FDA discouraged morcellation for the removal of the uterus or uterine fibroids, because the procedure poses the risk of spreading cancerous tissue in women with undetected cancer. J&J then halted sales and distribution of its morcellator devices.
Ethicon is removing its morcellator from the market and will reach out to customers and ask them to return their devices to the manufacturer. J&J is the biggest manufacturer in the market for laparoscopic morcellators with 72% of the market share, iData Research Inc. reported.
Cancerous tumors can masquerade as benign uterine fibroids and are difficult to diagnose and treat, according to an article in The Wall Street Journal. One in 368 women undergoing hysterectomies has undiagnosed uterine cancer cells and could be put at risk if the cancer is blasted elsewhere in the body during morcellation, the JAMA study found.
Women who suspect their morcellation hysterectomy expedited the development of cancer are urged to contact a law firm to seek justice for the physical and emotional pain they were left to endure.
The Legal Examiner and our Affiliate Network strive to be the place you look to for news, context, and more, wherever your life intersects with the law.