Commonly made from donated human skin tissue, AlloDerm patches are often used in hernia repair and breast reconstruction surgeries. However, studies link AlloDerm to after-surgery complications, which can be painful and potentially life-threatening. These conditions may lead to the body rejecting the AlloDerm patch, infection at the surgical site, or explantation. As a result of these complications, patients may have to undergo painful follow-up surgeries.

What You Can Do & How We Can Help

The Schmidt Firm, LLP is currently accepting AlloDerm induced injury cases in all 50 states. If you or somebody you know has been injured by AlloDerm, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Product Liability Litigation Group or call toll free 24 hours a day at (866) 920-0753.

AlloDerm: An Overview

Initially introduced to the market in 1994 by biotech company LifeCell to treat burn victims, AlloDerm is made of donated human/cadaver skin that is dried and chemically treated to remove all antigenic material (material that stimulates the production of antibodies in the immune system, causing the body to reject the cadaver skin). AlloDerm is used  to provide soft tissue reinforcement in surgical sites of the human body. Under FDA regulation, AlloDerm is most commonly used in hernia repair or breast reconstruction surgeries, usually after a mastectomy. Additionally, it is also used in surgeries to repair Periodontal (gum disease) and for facial reconstruction.

Unfortunately, many people who have been treated with AlloDerm have also experienced negative side effects. Studies have suggested that AlloDerm may cause abscesses, infection, inflammation and swelling in patients. These painful side effects may lead to more severe complications such as a high recurrence rate after hernia surgery, the body’s rejection of the AlloDerm tissue, and explantation (the need to remove the AlloDerm graft for various reasons).

Due to the severity of these symptoms, AlloDerm patients may want to contact a AlloDerm lawyer at The Schmidt Firm, LLP for a free case evaluation to discuss the potential for a AlloDerm lawsuit.

AlloDerm Side Effects

The following side effects may cause the need for explantation of the AlloDerm tissue:

• Severe injury to nearby organs
• Severe injury to blood vessels
• Adherence of intestines to the AlloDerm mesh
• Failure of proper incision healing
• Inflammation
• Swelling
• Extreme discomfort
• Recurrence
• Bruising and contusions
• Irritation
• Infection

AlloDerm and Hernia Studies

A hernia occurs when the lining of the abdominal wall tears, allowing parts or organs to protrude through the wall, which can cause extreme pain or discomfort. AlloDerm mesh is used to create a cover, so as to repair the hole in the abdominal in order to fully enclose the organs.

In a 2008 study of 70 patients who had received AlloDerm as part of a surgical hernia repair, 24 percent experienced complication. One patient experienced rejection of the graft, two had infection, and 14 had hernia recurrences. All of these complications resulted in additional surgeries.

According to another study, about 8 percent of patients required surgery to have the AlloDerm graft explanted, or removed.

Other AlloDerm complications that occurred after hernia repair include:

• Mesh erosion (breakdown of abdominal tissue due to irritation)
• Ring breakage
• Abscesses in the abdominal wall
• Mesh tear
• Mesh perforations (cracking of the mesh after attached to affected area)
• Adhesion issues (AlloDerm patches coming undone)
• Recurrence
• Improper healing of surgical incisions

AlloDerm and Breast Reconstruction

AlloDerm has been used in Breast Reconstruction surgeries since 2005. Typically, AlloDerm is used to create an internal sling to support the prosthesis.

In a study released in 2009, AlloDerm was associated with the increased risk for explantation (removal of the graft) in breast reconstruction surgeries performed after mastectomies. Researchers reviewed the charts of 321 patients who underwent breast reconstructions between 1998 and 2008. The 75 patients who received AlloDerm as part of the reconstructive surgery had a higher rate of needing the AlloDerm patch removed due to surgical complications, compared to patients in the control group.

As the researchers stated in the study abstract:

“The technique has great potential, especially for single-staged implant-based reconstruction; however, counseling patients about the higher risk of explantation is necessary.”

AlloDerm Recall

On September 30, 2005, LifeCell Corporation voluntarily recalled the following products from the marketplace:

• AlloDerm
• Repliform
• GraftJacket

The recall was prompted after concerns were raised about donor documentation received from one tissue recovery organization. It was determined that some of the donor tissue was harvested from individuals who had not consented to donate before their death. The recalled products all used tissue from Biomedical Tissue Services (BTS). BTS was shut down by the FDA on October 8, 2005 after president, Dr. Michael Mastromarino, and two other employees were convicted of illegally harvesting human bones, organs and tissue from individuals awaiting cremation, forging consent forms and selling the organs to medication companies.

The lack of documents also called into question the safety of the tissue BTS was harvesting and the surgeries it was being used in.

The 40 other tissue recovery organizations used by LifeCell were not affected in the recall.

Do I Have a AlloDerm Lawsuit?

The Schmidt Firm, LLP is currently accepting AlloDerm induced injury cases in all 50 states. If you or somebody you know has been injured by AlloDerm, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Product Liability Litigation Group or call toll free 24 hours a day at (866) 920-0753.

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