January 7, 2015 — A team of Canadian researchers have published a study linking the use of power morcellators in hysterectomies and fibroid surgeries with a possible risk of uterine sarcoma and parasitic myomas.
The study, published last month in the American Journal of Obstetrics & Gynecology, adds more evidence that time-saving morcellators pose life-threatening safety risks for women.
The researchers evaluated data on over 3,500 women who had a hysterectomy between 2001 and 2012, including 941 women who were treated with a power morcellator.
Almost immediately after the morcellator procedure, pathologists diagnosed three women with cancer by looking at tissues that were removed in the hysterectomy. In another three cases, the women were diagnosed soon afterward. None of the women had symptoms of cancer before the procedure. The only reliable way to diagnose uterine sarcoma is by examining tissue after it is removed from the body.
In the past, experts thought the risk of morcellators spreading cancer was low. However, the researchers found that 10 out of 941 (1.1%) of women were subsequently diagnosed with uterine sarcoma or a parasitic myoma, which is a benign (non-cancerous) fibroid that grows from morcellated tissue left inside the woman’s body.
The researchers estimated that uterine sarcoma would be diagnosed in 0.6% of women who were treated with a morcellator during a hysterectomy. Though numerically it might seem small, the estimate is three times higher than the FDA’s estimate of 1 in 350 (0.2%).
In November 2014, the FDA required a “Black Box” warning about the risk of uterine sarcoma from power morcellators. They also announced a Safety Alert to warn against the use of morcellators in the “vast majority” of women.
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