Research suggests patients who receive an AlloDerm graft as part of their reconstructive repair may be at risk of infection, recurrence and tissue rejection. These painful side effects may cause the need for the graft to be removed through another surgical procedure.
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
AlloDerm was introduced in 1994 by LifeCell as a treatment for burn victims. AlloDerm quickly became a form of soft tissue reinforcement to surgical sites during hernia repairs, breast reconstructive and facial reconstruction.
AlloDerm is a soft-tissue implant made from the processed skin of a cadaver. The skin is dried and chemically treated to remove all cells responsible for the body’s antigenic response, which is responsible for tissue rejection and graft failure. After it is rehydrated, the AlloDerm graft should be pliable, but remain strong.
Ideally, AlloDerm grafts should integrate into the surrounding tissue, providing a foundation for new tissue regeneration.
Unfortunately, many people who have received an AlloDerm graft have experienced complications after surgery. Studies suggest that AlloDerm may cause painful side effects including infection, rejection of the graft and even recurrence of the initial condition. As a result, AlloDerm complications may cause the need for explantation, or the need to remove the AlloDerm graft because of infection or other reasons.
Due to the severity of the complications associated with AlloDerm, you or somebody you know who received an AlloDerm graft and experienced post-operative complications may want to contact an AlloDerm lawyer or attorney with The Clark Firm to discuss the potential for a AlloDerm lawsuit.
Side Effects of AlloDerm Complications
The following side effects may be a sign of an AlloDerm complication, resulting in the need for the AlloDerm implant to be removed:
- Extreme discomfort
- Develop of abscesses
- Tearing of the mesh product
- Severe injury to nearby organs
- Severe injury to blood vessels
- Injury to other tissues close to the patched area
- Adhesion failure
- Failure of proper incision healing
- Tissue weakness
- Bruising and contusions
- Extrusion (a bulging or pushing out of the implant)
AlloDerm Complications in Hernia Repair
A hernia occurs when an organ protrudes through the wall of the cavity that normally contains it. The most common form of hernia occurs in the abdomen when the abdominal wall weakens and leads to a localized hole or defect, through which abdominal organs may protrude. AlloDerm grafts are used to create a cover over the defect, so as to repair the hole in the abdominal wall in order to fully re-enclose the organs.
In a study conducted by the Fairview Hospital Department of Surgery, researchers studied AlloDerm use in tissue reconstruction during hernia repairs. The study followed 70 patients starting in October 2003.
Fourteen of the patients suffered one or more complications. Of these patients, one suffered rejection, two experienced infection and 14 had hernia recurrences.
Said the researchers about the study,
“Early results in repair of abdominal hernia with AlloDerm appear to have a complication rate of 24 percent. Recurrence is the most common complication.”
After concerns were raised about donor documentation received from one tissue recovery organization, LifeCell Corporation voluntarily recalled several of its products on September 30, 2005.
The products included:
It was determined some of the donor tissue was illegally harvested from donors who did not give consent before their death. All of the suspicious materials came from Biomedical Tissue Services. After president Dr. Micahel Mastromarino and two other employees were convicted of illegally harvesting human bones, organs and tissues, the FDA shut down BTS on October 8, 2005. The harvested material came from individuals that were awaiting cremation. The BTS employees forged consent forms and sold the organs to medical companies.
The 40 other tissue recovery organizations used by LifeCell were not affected by the recall.
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