Study Showed AlloDerm Complications

Trenton, NJAs plaintiffs involved in AlloDerm complications lawsuits wait for the bellwether trials to go ahead, experts are looking back on what some studies found regarding AlloDerm skin graft adverse effects. AlloDerm has been around since the 1990s, and has a good track record, but that does not mean people have not suffered adverse events.

A small study published in 2008 in the journal Hernia found an overall complication rate of 24 percent linked to the use of AlloDerm grafts. Because the study was small - it only included 70 patients (31 men and 39 women) - more research must be done to confirm the findings, but researchers did find a high rate of hernia recurrence.

Of 70 patients involved in the study, 20 percent suffered a complication, with the overall complication rate being 24 percent (the higher percent is due to some patients experiencing multiple adverse reactions). Among the complications were one rejection of the graft, two infections and 14 hernia recurrences. All patients with a hernia recurrence required medical repair of the problem.

Overall, the highest complication found in the study was recurrence of the hernia, with the strongest link to recurrence found in patients who received a thicker mesh product. Those who received a thinner mesh had a lower rate of hernia recurrence.

AlloDerm, made by LifeCell, was approved in the 1990s to treat patients with burn injuries. The device is known as a cadaveric allograft because tissue used in AlloDerm is taken from human cadavers. Some AlloDerm units were subject to a recall in 2005 due to documentation issues concerning donor tissues.

But according to the Master Complaint in AlloDerm litigation (In RE: AlloDerm Litiagtion, Case Number 295), LifeCell has undertaken a silent recall of AlloDerm by no longer marketing, advertising or promoting the device for hernia repair. The complaint goes on to allege that LifeCell began marketing, promoting and advertising LifeCell for hernia repair as early as 1994, despite allegedly not having carried out sufficient testing on the product to determine if it would stretch, expand, pull, sag, loosen or otherwise fail. The lawsuit alleges that LifeCell knew or should have known about those issues when it began marketing AlloDerm for hernia repair.

According to the lawsuit, in 2008, LifeCell warned surgeons that AlloDerm could stretch up to 50 percent when implanted.

Lawsuits have been filed against LifeCell, alleging patients who received AlloDerm for hernia repair suffered serious adverse reactions, including infection, pain, hernia recurrence, sickness and disability. Bellwether trials in the AlloDerm litigation are scheduled to begin in September 2015.