FDA panel to discuss risks of laparoscopic device

A Food and Drug Administration advisory committee will meet this week to discuss whether laparoscopic power morcellator devices, which are used to remove uterine fibroids or a patient's uterus, should be reclassified as high-risk medical devices.

If morcellator devices were reclassified as high-risk, they would be subject to a premarket approval application. Power morcellation devices, made by a few companies including Johnson & Johnson and Karl Storz, have been in use since the early 1990s, but there has been a recent spate of safety concerns about whether the devices can cause the spread of cancerous tissue in a patient's body.

The FDA in April began to discourage morcellation for hysterectomies or the removal of uterine fibroids because of the risk of spreading unsuspected uterine sarcoma.

During surgery, morcellators are used to cut the tissue to allow for the removal of the fibroids or uterus in pieces. Market analysts say about 50,000 of the 600,000 hysterectomies performed each year are associated with morcellation devices.

Other risks can include injury to organs, especially in cases where the physicians are not adequately experienced users of the technology.

Using a morcellator device also can mean the procedure itself takes longer, said Dr. Natalya Danilyants, a gynecologic surgeon who practices in Maryland.

The meeting is scheduled for July 10 and 11.

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