Washington, DCWhile it may not necessarily be an occasion to break out the balloons and noisemakers, 2014 is nonetheless an anniversary of sorts for AlloDerm by LifeCell. It was in 1994 that the skin graft product, harvested from cadavers via a carefully controlled process, made its debut on the market.
Since that time, AlloDerm skin graft has enjoyed a good track record of success in areas of reconstructive surgery, hernia repair and burn treatment. As recently as March of this year, a published report in The Lancet (“Burns in children: standard and new treatments,” Dr. Marc G. Jeschke MD and David N. Herndon PhD, 3/29/14) articulated the virtues of AlloDerm as a treatment and skin replacement for patients having suffered full-thickness burns. “Alloderm (sic) consists of cadaveric dermis devoid of cells and epithelial element. Dermal analogue is used in a similar way to other dermal analogues, and it has produced favorable results.”
However, while results have been favorable, LifeCell Corporation (LifeCell) has not escaped complaints about the product - especially for indications related to hernia repairs, given the potential for AlloDerm to stretch up to 50 percent above its original dimensions, providing complications for the patient. To that end, according to LawyersandSettlements.com’s Heidi Turner, LifeCell has quietly stopped promoting and marketing AlloDerm for hernia repair. This, according to the Master Complaint in AlloDerm litigation (In RE: AlloDerm Litigation, Case Number 295), which alleges that LifeCell knew or should have known about the possibility for sagging and stretching for indication of hernia.
There have also been cases of AlloDerm infection. The official website of the US Food and Drug Administration (FDA) carries an adverse event report related to infection in a patient having received the skin graft for AlloDerm reconstructive surgery.
It should be noted that LifeCell undertook a recall of AlloDerm in 2005 when it was discovered that internal quality protocols inherent with a certain supplier put into question the integrity of the skin grafts. The fact that AlloDerm skin grafts are harvested from cadaver tissue increases the concern over integrity. Not only did LifeCell recall all lots of the product, the manufacturer duly notified all users or potential users of the product, including hospitals and health care professionals, as well as the FDA.
Still, plaintiffs in lawsuits citing AlloDerm Skin Grafts Adverse events claim that LifeCell could have done better to minimize complications and AlloDerm infection. And there are alternatives to AlloDerm, as The Lancet spelled out. Integra, referenced as the oldest and best-studied product for dermal substitution, employs not cadaver tissue but bovine (cow) collagen and glucosaminoglycans, “which allow fibrovascular ingrowth.”
There is little doubt that alternatives to traditional methods of harvesting skin grafts from other parts of the human body in order to treat a serious burn or other substantive injury to the skin are important for patients with large swaths of dermis that have been impacted negatively. And while AlloDerm has been used successfully in scores of patients, there have been problems nonetheless.
When AlloDerm reconstructive surgery goes wrong after the fact, due to stretching or an AlloDerm infection, legal action is often the only option with which to offset medical bills and achieve compensation. You can be sure that even the most successful medical device manufacturer, with the most successful products, routinely budgets for just that…
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