Study Supports FDA Data on Morcellator Cancer Risks

Study Supports FDA Data on Morcellator Cancer RisksJuly 22, 2014 — About one in 370 women who undergoes a hysterectomy using a morcellator actually has undiagnosed cancer, according to a study published in the Journal of the American Medical Association (JAMA).

The findings support conclusions of an FDA analysis back in April, which found undiagnosed cancer in about 1 in 350 women who had a hysterectomy for fibroids. About one in 500 women had a highly-aggressive type of uterine cancer known as leiomyosarcoma (LMS).

The FDA warned that morcellators should not be used in hysterectomies because they can potentially spread malignant cancer throughout a woman’s abdomen, greatly worsening her chances of long-term survival.

Out of nearly 233,000 women who had a minimally-invasive hysterectomy between 2006 and 2012, morcellation was used in 15.7% of surgeries. Among women who underwent morcellation, researchers found the following prevalence of cancer:

  • 99 cases of uterine cancer (27 cases per 10,000 women)
  • 26 cases of other gynecological malignancies (7 cases per 10,000 women)
  • 39 uterine neoplasms that might be malignant cancer (11 cases per 10,000 women)
  • 368 cases of endometrial hyperplasia (101 cases per 10,000 women)

The prevalence of uterine cancer increased significantly with age, especially for women over 50 years old.

Earlier this month, an advisory panel to the FDA met to discuss the cancer risks of morcellation. Public safety advocates are calling on the FDA to ban the devices. Many hospitals have already sharply curtailed use of the devices.

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