AlloDerm Skin Grafts Causing Pain, Infection and other Adverse Health Events

Washington, DC: Alloderm, a type of skin graft used mainly for reconstructive breast surgery and hernia repairs, is reportedly causing adverse health events in some people. The types of complications can include infection, abscesses, pain and soreness, and inflammation and swelling. They can be painful and in some cases life threatening, and may require further surgery, at additional expense and trauma to the patient.

Developed in 1994 by LifeCell as an alternative to traditional skin grafts, AlloDerm uses skin cells donated from human skin tissue supplied by US AATB-compliant tissue banks.

On September 30, 2005, LifeCell initiated a recall of certain AlloDerm products. The recall was prompted when internal quality processes raised questions about the donor documentation received from one tissue recovery organization. Specifically, the company recalled all lots of product that were produced using tissue from Biomedical Tissue Services (BTS). Life Cell promptly notified the FDA and all relevant hospitals and medical professionals.

Today, Alloderm is generally considered safe and effective in helping skin regenerate following surgery or injury, however complications can occur, and there is information to indicate that approximately 30 AlloDerm recipients reported problems such as infection, abscess, or the need for additional surgical procedures following the recall, between 2007 and 2009.

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Published on Sep-28-10