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FDA Alert Regarding Dermal Filler

Posted by Frank Spector | Aug 06, 2014 | 0 Comments

Expression Injectable by Enhancement Medical: FDA Safety Communication – Adverse Events Associated with Unapproved Use As a Dermal Filler

AUDIENCE: Dermatology, Surgery, Dentistry, Nursing

ISSUE: The FDA has become aware of adverse events associated with the unapproved use of the Expression product, hyaluronic acid that is packaged in a syringe, as a dermal filler. Events have included swelling, tenderness, firmness, lumps, bumps, bruising, pain, redness, discoloration, itching, and the development of hard nodules.

BACKGROUND: Expression is listed with the FDA as an intranasal splint, and is intended to minimize bleeding and swelling and to prevent adhesions (sticking together) between the septum and the nasal cavity. Intranasal splints are placed in the nasal cavity after surgery or trauma and are usually constructed from plastic, silicone, or absorbent material.

The FDA issued a warning letter to Enhancement Medical LLC on June 4, 2014, advising the company of multiple quality system, correction/removal, and medical device reporting violations that were revealed during an inspection.

RECOMMENDATION:  FDA recommends that health care providers stop using Expression by Enhancement Medical LLC as a subcutaneously administered substance and instead use the list of FDA approved fillers.  In addition, patients who have received treatment with Expression as a dermal filler should be monitored for adverse events and referred for corrective treatment when appropriate. For further detailed instructions for people undergoing procedures that use dermal fillers or their health care providers please see the FDA Safety Communication.

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Frank Spector

Welcome to my profile page. Choosing a lawyer is a big decision. Here is some information so you can get to know me better. I am the third generation of lawyers in my family. I saw how lawyers can help people get justice for their injuries. So for over 30 years, I have helped those injured by m...

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