January 7, 2015 — A recent study has added even more evidence that the use of power morcellators in gynecological surgery may spread uterine cancer, greatly worsening a patient’s prognosis.
The study was published in the American Journal of Obstetrics & Gynecology in December 2014.
Researchers looked at data on about 3,500 women who had a hysterectomy from 2001-2012. Of these women, 941 women were treated with a power morcellator.
Immediately after the surgery, pathological evaluation of morcellated tissue found uterine sarcoma in three patients. Another three patients had delayed diagnosis of uterine sarcoma. In total, 10 out of 941 (1.1%) of women were diagnosed with uterine sarcomas or parasitic myomas.
A parasitic myoma is a fibroid (myoma) that starts growing in the uterus when morcellated tissue is left behind in the woman’s abdomen. It is a benign (non-cancerous) tumor.
Overall, the researchers estimated that 0.6% of women who have a hysterectomy with a morcellator will be diagnosed with uterine sarcoma — an estimate that is three times higher than what the FDA estimated last year. The researches recommended that women be informed of this risk before the surgery.
In November 2014, the FDA issued a Safety Alert to warn against the use of power morcellators in the “vast majority” of women undergoing a hysterectomy or fibroid surgery.
The FDA also announced that they would require a “Black Box” warning about the risk of disseminating cancer on the label for power morcellators. The FDA estimates that 1 in 350 women (0.2%) who has a hysterectomy or surgery to remove fibroids actually has undiagnosed uterine sarcoma, and 1 in 500 has highly-aggressive leiomyosarcoma.
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