AlloDerm by LifeCell Corporation is a human derived tissue fashioned from dermis (skin) harvested from cadavers, which then undergoes a rigorous processing routine to remove the original cells in hopes to diminish the likelihood of rejection by the recipient. Long term, the skin graft is supposed to provide rapid revascularization and repopulation of the recipient’s own cells. Originally, it was approved and marketed for use in burn victims and for periodontal and reconstructive surgeries, but has found more uses since then, most notably for hernia repair.
LifeCell has had thousands of successful procedures as an alternative to traditional skin grafting, yet for some patients, there have been problems with their AlloDerm reconstructive surgery. For hernia repair, there have been hundreds of reports of infection, tearing of the AlloDerm patch, perforations and other problems.
The US Food and Drug Administration (FDA), which approved the LifeCell product in 1994, carries an adverse event report for AlloDerm on its official “MAUDE” adverse event page, detailing the difficulty of a patient who underwent a bilateral mammary reduction with an AlloDerm sling in 2008. According to the adverse event report, the patient was re-admitted to the hospital four days later due to reports of a foul odor and apparent AlloDerm infection. The patient underwent an incision in her right breast for drainage and removal of two units of AlloDerm.
A small study on AlloDerm use in abdominal hernia repair, published in the professional journal Hernia in June 2008, followed the outcomes of 70 patients having received the AlloDerm surgery for hernia repair. The study found a 24% overall complication rate with 10 of the 70 patients requiring revision surgery due to AlloDerm infection and other complications.
Plaintiffs report various AlloDerm Skin Graft adverse events that include:
- Severe pain
- Adhesion failure
- Shrinkage or thinning of the mesh
- Organ damage
- Opening of the hernia
- Need for addition surgery
All of these adverse events can lead to serious injuries to a patient’s abdominal area (in the case of hernia repair), and quite often requiring revision surgery.
The first lawsuit against the manufacturer of AlloDerm was in May of 2011. Since that time, over 300 plaintiffs have filed lawsuits, yet AlloDerm has not yet been certified for MDL. However, it is currently under centralized court management (CM) in New Jersey Superior Court Case no. 295 in Middlesex County. In the CM cases of AlloDerm, a court order was handed down on December 4, 2014 specifying the schedule for the selection of bellwether trials. September 2015 will be the first set of bellwether trials to be held in the state court of New Jersey for a handful of the AlloDerm plaintiffs.
If you or someone you love have been injured or have experienced the above listed symptoms after having AlloDerm surgery, you should contact an AlloDerm lawyer for a free case review.