Patients who underwent hernia repair surgery with an AlloDerm Tissue Matrix graft may be at an increased risk of serious complications compared to other hernia repair patients. According to one study, patients who receive an AlloDerm hernia repair are five times more likely to require repair surgery than recipients of another hernia repair product.
AlloDerm is a human-derived tissue that is manufactured by LifeCell. Essentially, an AlloDerm graft is human skin tissue from another donor that is chemically treated to remove all cells and cell markers that could cause the body’s defense systems to reject the tissue implant. In addition to its use in hernia repair, AlloDerm is also employed in facial reconstruction and breast reduction.
The Food and Drug Administration has received dozens of reports from patients who experienced side effects with the use of an AlloDerm hernia repair. Potential side effects associated with AlloDerm include injury to nearby organs or blood vessels, infection, inflammation, abscess and damage to the patch that can limit its ability to hold an abdominal hernia in place.
In September 2005, the FDA ordered an AlloDerm recall after concerns were raised about donor identification for tissue samples that were used to manufacture the hernia patches. The recall affected all AlloDerm lots that were manufactured by Biomedical Tissue Service (BTS).
If you or a loved one used an AlloDerm hernia repair and underwent additional surgeries or experienced other side effects with the device, you may be eligible to file a lawsuit. For a free legal consultation, contact the lawyers at Hissey Kientz, LLP by calling toll-free at 1-866-275-4454, or by filling out the free case evaluation form located on this page.