ANSWERS TO YOUR
QUESTIONS ABOUT
ALLODERM® ACELLULAR
DERMAL GRAFT

THE PRODUCT
WHAT IS AN ALLOGRAFT?
An allograft is any human tissue that is transplanted from one person to another. Kidneys, hearts, corneas, bone, skin, and other tissues are generously donated by individuals or their families. Allograft tissues have been used in millions of surgical procedures for many years.

WHAT IS ALLODERM DERMAL GRAFT?

AlloDerm is a tissue graft processed from donated allograft skin. LifeCell Corporation removes cells from the donor skin leaving only the collagen scaffold of the dermis (the bottom layer of skin.)

HOW DOES LIFECELL OBTAIN DONATED SKIN?

Tissue banks throughout the United States surgically remove skin from donors using sterile operating room techniques. The skin is placed into an antibiotic solution and shipped to LifeCell. Donors and their families receive no financial compensation for these donations and donated tissues are not bought or sold. However, fees are paid to cover the standard costs for obtaining, testing, processing and shipping the tissues.

HOW LONG HAS ALLODERM BEEN USED?

Use of AlloDerm began in 1992 for burn patients and in 1994 for periodontal surgery and plastic and reconstructive surgery. Currently, more than 40,000 patients have received AlloDerm grafts.

IS IT REGULATED BY ANY AGENCY?

AlloDerm is regulated by the U.S. Food and Drug Administration (FDA) as banked human tissue for transplantation to repair or replace damaged or inadequate soft tissue.

PROCESSING AND SAFETY
HOW IS ALLODERM MADE?

LifeCell Corporation processes the human donor skin in order to remove the cells. This process involves removing the epidermis (the top layer of skin cells) and all of the cells in the dermis. The remaining material is a collagen framework which provides strength to the skin. There are no components left to cause the rejection or inflammation that usually occurs with unprocessed tissue transplants. Therefore, when transplanted to a patient, the AlloDerm graft gradually becomes a natural part of the patient's own tissue and performs like normal, healthy tissue thereafter.

ARE ALLODERM GRAFTS SAFE?

Before LifeCell receives donated skin, the tissue donors undergo rigorous screening by the Tissue Bank. The donor's medical and social history and cause of death are carefully reviewed and documented. Blood samples are extensively tested by the Tissue Banks, or a certified laboratory, using FDA-licensed tests. The donor must be found negative for Hepatitis B and C, HIV Types 1 and 2 antibodies (screenings for AIDS), and syphilis. As an extra safeguard, AlloDerm grafts undergo microscopic and other analytical testing, both before and after proce