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April 18, 2014
Doctors, FDA Caught Napping on Gynecological Safety
America's medical community and, for that matter, the Food and Drug Administration itself, aren't looking any too good relationally in the wake of an FDA "safety communication" advising against the continued use of a device in gynecological surgery that has been associated with a risk of cancer and was flagged in coverage by The Wall Street Journal. The FDA began its review of the device (power morcellators) in December, an FDA official said at a press conference yesterday, "when some high-profile cases covered in the media came to our attention."

Meantime, misgivings over "morcellation" had been stirring up the gynecological community. But gynecologists often weren't advising women of the cancer-spreading risk of the procedure, low as it may be. Somehow, the practice of medicine with "informed consent" was overlooked. Morcellation is viewed as a less intrusive way of doing a hysterectomy. There are methods for morcellation (doing the surgery in a bag) that increased the safety of the procedure, but they often weren't used, The Journal reported.

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Doug Bedell has a background in journalism and PR and is the owner of Resource Relations LLC in Central PA, focusing on organizational and crisis communication. He’s the community manager of SimplyFair.net, a social network on fairness. On the Web, Doug’s at www.ResourceRelations.com. On Twitter, he’s @DougBeetle.
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