Commonly made from donated human skin tissue, AlloDerm patches are often used in hernia repair. 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 explanation.
January 15, 2013 — A total of 304 lawsuits have been filed, including dozens in the last few weeks. The litigation continues to grow at a rapid pace. Click here to read more.
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, PLLC for a free case evaluation to discuss the potential for a AlloDerm lawsuit.
Alloderm Class Action Lawsuit
Hundreds of people have filed lawsuit after they were injured by Alloderm, but these cases are not part of an Alloderm class action. Instead, they are individual lawsuits filed by people who hired an attorney. Over 300 cases are centralized in a Multi-County Litigation (MCL) in New Jersey. This litigation is centralized like a class action, but unlike a class action, each case can have its own outcome. Click here to read more.
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
- Extreme discomfort
- Bruising and contusions
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)
- Improper healing of surgical incisions
On September 30, 2005, LifeCell Corporation voluntarily recalled the following products from the marketplace:
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.