AlloDerm is a type of skin graft used mainly for reconstructive breast surgery and hernia repairs. Patients are reporting adverse effects on their health including infection, abscesses, pain and soreness, and inflammation and swelling. These side effects are extremely painful, and in some instances have been life threatening. The injuries have required further surgery causing additional expenses and undue trauma to the patient.
AlloDerm uses skin cells donated from human skin tissue as an alternative to traditional skin grafts. The medical journal Hernia, in 2008 found that 24 percent of complications were linked specifically to the use of AlloDerm grafts.
Bellwether plaintiffs for the suits are expecting the trials to begin September 2015. According to the Master Complaint, LifeCell began a silent recall of AlloDerm by no longer marketing, advertising or promoting the device for use in hernia repair surgeries. The recall was prompted when internal quality processes raised questions about the donor documentation received from one tissue recovery organization.
The complaint alleges that LifeCell began marketing, advertising, and promoting LifeCell specifically for Hernia repair without carrying out sufficient testing to ensure its success. The lawsuit continues by saying that LifeCell should have known about the issues when marketing the product.