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FDA issues safety alert on soft tissue fillers

June 05, 2015

By Michelle Manchir

Food and Drug Administration MedWatch

The U.S. Food and Drug Administration on May 28 issued a safety alert targeting, in part, health care providers including dentists regarding the risk of serious patient injury with the unintentional injection of soft tissue filler into blood vessels in the face.

The MedWatch alert summarized the FDA review of documentation about these injections resulting in rare but serious side effects including blocked blood vessels and restricted blood supply to tissues, sometimes resulting in embolization. According to the FDA, this means the filler material has traveled to other parts of the body, which can cause vision impairment, blindness, stroke and damage and/or death of the skin (necrosis) and underlying facial structures.

Among the FDA’s recommendations for health care providers in the safety communication are:

Do not inject soft tissue fillers if you do not have appropriate training or experience.

Familiarize yourself with the anatomy at and around the site of injection.

Thoroughly inform the patient of all risks of the procedure and the specific product you intend to use.

Know the signs and symptoms associated with injection into the blood vessels and have an updated plan detailing how you plan to treat the patient if this should occur.

The FDA is working with manufacturers to update their labeling and requests that labeling include additional warnings, precautions and other statements about the risk of unintentional injection into blood vessels so that health care providers and patients have a better understanding of the risks.

The FDA recommends anyone who suspects or experiences a problem with soft tissue fillers to file a voluntary report through MedWatch, the FDA’s safety information and adverse event reporting program.

Dentists can look for other safety alerts and product recalls on the ADA Safety Alerts website by visiting ADA.org and searching for “Safety Alerts.”

Dentists can report adverse events to FDA

Dentists and other health care providers can voluntarily report adverse events and medication errors to the U.S. Food and Drug Administration Adverse Event Reporting System.

This database contains information on adverse events reports submitted to the FDA, and it is designed to support the FDA’s post-marketing safety surveillance program for drug and therapeutic biologic products.

Dentists can also report adverse events and/or medication errors to product manufacturers, which are required to send the reports to FDA.

Every year the FDA receives thousands of complaints and reports from health care providers, consumers and others through this program. The FDA then evaluates them and in some cases issues safety alerts and/or recalls.

Dentists and other health care providers can use the online MedWatch form to report adverse events that they observe or suspect for human medical products, including serious drug side effects, product use errors, product quality problems and therapeutic failures for medical devices, medicines or other products.

For more information, visit www.fda.gov and search for “MedWatch.”