June 04, 2015
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ASDSA supports FDA directive for warnings on dermal fillers

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The American Society for Dermatological Surgery Association has announced its support for a recent FDA directive that soft-tissue filler manufacturers include additional precautions on product labels.

“The FDA ruling reinforces our consistent advice that dermal fillers such as Restylane, Juvederm and others should only be administered by experienced, board-certified dermatologists who have appropriate training and who are knowledgeable about facial anatomy,” Mitchel P. Goldman, MD, American Society for Dermatologic Surgery Association (ASDSA) immediate past president, said in a press release. “We agree that patients should be fully informed of any risks. With proper education, patients can make good decisions about where to go for treatment.”

Mitchel P. Goldman, MD

Mitchel P. Goldman

The FDA recently issued a warning to health care providers about the possibility of rare, but serious injuries that can occur due to unintentional injection of soft tissue filler into blood vessels in the face. The agency is asking manufacturers to include new warnings about the risk of serious injury due to possible unintentionally injecting fillers into blood vessels, the ASDSA release stated.

The ASDSA has issued a formal board-approved position that states “only properly trained physicians should be injecting dermal fillers and botulinum toxins. Training should include an extensive understanding of cutaneous medicine and the aging face, knowledge of the various FDA-approved injectable products and their indications, experience in injection techniques appropriate to products, and pre-and post-procedure care involved in treatment,” the release stated.