| A Safety Communication has been posted titled, "Adverse Events Associated with Use of Enhancement Medical's "Expression" Intranasal Splint as a Dermal Filler." The FDA has become aware of adverse events associated with the use of Expression (also known as Expression Injectable) as a dermal filler, and these events have included swelling, tenderness, firmness, lumps, bumps, bruising, pain, redness, discoloration, itching, and the development of hard nodules. The FDA has not approved this product for use as a dermal filler and recommends that health care providers stop using Expression by Enhancement Medical LLC as a subcutaneously administered substance. To read the Safety Communication, please see: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm407900.htm |

