AlloDerm Patch for Hernia Repair: Time Line
The lawyers at Saiontz & Kirk, P.A. are reviewing potential AlloDerm patch lawsuits for problems following hernia repair, where the product may begin to stretch or thin out, resulting in bulging and other painful injuries. Many individuals who have experienced problems are now questioning why this product was ever marketed and promoted for surgery to repair a hernia.
AlloDerm Regenerative Tissue Matrix was the first commercial product introduced by the manufacturer, LifeCell Corporation. While it was first introduced in 1992 for use with burn victims, the company began selling the AlloDerm patch for hernia repair and other abdominal surgeries, even though it was never adequately tested or determined to be safe and effective.
Because it is comprised of soft tissue that is harvested from cadavers, Alloderm is classified as banked human tissue. Therefore, it was never approved by the FDA as a medical device for use during hernia repair. However, LifeCell still had an obligation to ensure that AlloDerm was safe and effective for use as a hernia patch, and failed to test the long-term outcomes of the product or provide adequate warnings about the risk of problems.
AlloDerm Time Line
- 1992 – AlloDerm patch was first used for burn patients
- 1994 – AlloDerm was used for periodontal surgery and plastic and reconstructive surgery
- 1994 – LifeCell began promoting and selling AlloDerm patch for hernia repair and abdominal reconstruction, but they provided no information on labels, package inserts, instructions or the company website about such surgical use
- 2000 – LifeCell began actively and openly promoting AlloDerm for hernia repair, promoting the patch without conducted any testing to determine whether it was safe and effective. The company also failed to provide instructions or any referrences that AlloDerm should be “pre-stretched” before hernia repair to avoid the patch loosening, thinning, sagging or spreading following surgery.
- March 2000 – LifeCell provided instructions to physicians that only indicated that physicians should suture AlloDerm intraoperatively “under significant tension” and “after proper re-hydration”, but did not provide any specific indication to pre-stretch AlloDerm for hernia surgery.
- 2000 – 2008 – LifeCell continued to promote AlloDerm without warnings about hernia repair problems, increasing annual revenues for the product to $167 million by 2007, while they knew or should have known that users were experiencing serious problems from AlloDerm following hernia repair as a result of the patch stretching after being implanted.
- 2008 – Information was provided to surgeons that AlloDerm can be stretched up to 50%, which allows for smaller pieces to be purchased that can then be stretched out to increase size of the graft.
AlloDerm Hernia Repair Lawsuits
As a result of the manufacturers decision to place their desire for profits before patient safety, financial compensation may be available through an Alloderm product liability lawsuit. The lawyers at Saiontz & Kirk, P.A. are reviewing potential claims for individuals throughout the United States and all cases are reviewed on a contingency fee bases, which means that there are no out-of-pocket expenses to hire a law firm and we receive no attorney fee unless a recovery is obtained.
To review a potential case for yourself, a friend or family member, request a free consultation and claim evaluation.