AlloDerm is not new. The LifeCell Corp. (LifeCell) product was first approved by the US Food and Drug Administration (FDA) in the early 1990s for use with burn victims and some dental procedures. The high-tech regenerative tissue matrix was thought to augment healing for serious burns, together with the aforementioned select periodontal procedures.
However, AlloDerm by LifeCell appears to have found a larger and more sustainable market for use in hernia surgery and abdominal repair - a function that will see increased demand as Baby Boomers hit middle age, not to mention bulging midriffs of epic proportions. There have been reports that AlloDerm has been aggressively marketed for hernia and abdominal procedures, off-label, since 2000.
While doctors, surgeons and health care professionals have the moral, legal and professional authority to deploy drugs and medical devices for uses not necessarily approved or condoned by the FDA, manufacturers do not have the authority to market products for uses not approved by the FDA.
It should be noted that some 300 lawsuits alleging AlloDerm Infection and other problems currently on the books in state court in New Jersey, all involve complications due to hernia repair and/or AlloDerm reconstructive surgery.
Is AlloDerm Infection a “dead” giveaway?
In 2005, the AlloDerm Acellular Dermal Matrix Skin Tissue was subject to a Class II recall through the FDA (the recall was initiated by LifeCell, according to the recall report). The reason? “Human Tissues, procured from donors without adequate donor eligibility determinations, were distributed.” Specifically - 1,652 allografts from 102 lots.
READ MORE ALLODERM SKIN GRAFT LEGAL NEWS
Does the issue with AlloDerm Infection and other adverse events have any relation to the origins of the AlloDerm skin grafts?
According to court records, there are 330 lawsuits currently consolidated in New Jersey State Court before Superior Court Judge Jessica R. Mayer. None of the lawsuits involve burn victims or those who may have received AlloDerm by LifeCell for periodontal surgery.
Rather, all of the plaintiffs alleging AlloDerm Skin Grafts Adverse events have issues stemming from hernia surgery or abdominal repair, two functions not originally approved by the FDA.
LifeCell maintains its headquarters in New Jersey.