AlloDerm Lawsuits: The Problem

AlloDerm, an FDA approved banked human tissue, was introduced to the market for use in skin replacement procedures for burn victims. Since its introduction, it has been commonly used in plastic and reconstructive surgery, periodontal surgery and hernia repair surgery. Recent studies raise concerns of an unacceptable rate of hernia recurrence in patients who had an abdominal hernia repair with AlloDerm. Plaintiffs’ attorneys are now looking at potential AlloDerm abdominal hernia repair lawsuits alleging that hernias repaired with AlloDerm have repeatedly returned, causing patients great pain and often requiring additional surgery. If you think you may have a claim, call 800-553-8082 or get a free online consultation.

Background
AlloDerm, or AlloDerm® Regenerative Tissue Matrix, is derived from cadaveric or donated skin and is manufactured by LifeCell Corporation. The human skin is processed and purified to remove cells. AlloDerm is promoted by LifeCell Coporation to be a safe and effective product for the repair of abdominal hernias.

Hernia repair has evolved over the past twenty years from a simple suture repair to mesh repair using either synthetic or biologic meshes. In hernia repair surgeries requiring an open abdomen or in contaminated/infected areas, synthetic meshes cannot be used due to their high risk for complications. As such, the primary alternative is biologic meshes such as AlloDerm.

There are, however, risks associated with the use of biological meshes. The AlloDerm Hernia Repair patch has been reported to have a complication rate of up to 24%. Complications associated with AlloDerm often require additional surgeries, leading to more pain and potential for complications for the patient. Often, it must be replaced with mesh explants due to fluid accumulation resulting from implantation of the graft.

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A review of the literature has found that twenty three studies on AlloDerm used in hernia surgeries have been published in peer reviewed journals. These studies report a recurrence rate ranging between 0% and 100%. In 2004, a study was published in the Annals of Plastic Surgery which reviewed 44 patients receiving AlloDerm to repair ventral hernias. The mean follow-up time was 20 months. 8 of the patients had previous wound infections and reported no complications or postoperative infections. However, in a study in the the American Journal of Surgery 67 patients, with an average follow up of 10.6 months receiving abdominal wall reconstruction with AlloDerm, reported an 18% recurrence of hernias (12 patients). 11 patients had wound infection and 2 patients required removal. A further 3 patients developed seroma and 3 developed fistulas. In another study, researchers reported on a clinical study involving 33 patients who received AlloDerm to repair ventral hernias. Patients were followed for 18 months. The rate of hernia recurrence was 24%. 6% of patients developed seroma and 45% developed diastasis or bulging of muscle. A recurrence rate of 46% in patients receiving AlloDerm hernia repair compared to 11% in patients receiving a synthetic mesh has been reported. Recurrence rates of several studies vary between 0% and 73%. One study reported a rate of recurrence of 67% 60 days post surgery and 100% 1 year post surgery in a small study on 10 patients undergoing large traumatic open abdomen reconstruction.

If you think you may have a potential AlloDerm lawsuit, call 800-553-8082 or get a free online consultation.

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