July 8, 2014 — The U.S. Food and Drug Administration (FDA) will be assessing the risk of cancer associated with laparoscopic power morcellators in a meeting on June 10 and 11.
According to an FDA Executive Summary (PDF) of meeting materials, the advisory panel will discuss ways to mitigate risks. The FDA has already discouraged the use of morcellators in hysterectomies due to cancer concerns.
About 1 in 350 women who has a hysterectomy to treat uterine fibroids actually has undiagnosed cancer. If a morcellator is used to cut up the fibroid, it can potentially leave malignant cells behind — especially if the doctor does not use a protective surgical bag.
The FDA reported 17 cases of cancer associated with the use of morcellators. The first report was submitted in December 2013, but some events occurred as early as 2006. About 43% of the events occurred in women under 50 years old. The most commonly-reported tumor was leiomyosarcoma (LMS), a highly aggressive form of uterine cancer.
The advisory panel will discuss the benefits and risks of morcellators in the use of uterine fibroids, consider whether tools like surgical bags can improve safety, and decide whether specific labeling related to the risk of cancer should be required for the devices.
The FDA might add a “Black Box” warning or re-classify the devices as “high-risk,” which would prevent manufacturers from introducing new products without rigorous safety studies. The largest manufacturer, Johnson & Johnson, has suspended sales of the devices in the meantime.
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