Over 300 AlloDerm lawsuits have been filed against LifeCell Corporation. Plaintiffs accuse LifeCell of recklessly marketing AlloDerm without conducting adequate safety tests or warning about the risk of severe complications if the patch is not “pre-stretched” before surgery. Severe complications include infection, explantation, hernia recurrence, organ damage, extreme pain, and the need for additional surgery.
What is AlloDerm Hernia Mesh?
AlloDerm Regenerative Tissue Matrix is a banked human tissue graft that is manufactured and marketed by LifeCell, a company based in New Jersey. AlloDerm is tissue-based and made from human cells, and therefore is not classified as a medical device by the FDA. It is used in abdominal repair surgeries, hernia repair surgeries, breast reconstruction, burn treatment, plastic surgery, and other reconstructive surgeries.
What is the problem with AlloDerm?
In 2000, LifeCell began promoting AlloDerm for use in hernia repair and abdominal reconstructive surgery. However they never told surgeons that the AlloDerm patch must be “pre-stretched,” or else the surface area of the patch will increase by 30-50% and it will stretche, expand, sag, or become thinner after it is implanted. To avoid problems, it is necessary for surgeons to suture AlloDerm under significant tension.
Between 2007 and 2009, there were at least 29 incidents in which AlloDerm recipients reported experiencing painful and potentially life-threatening side effects. Due to these reports, lawsuits are being filed against LifeCell to cover medical expenses, pain and suffering, lost income, permanent injuries, and more.
The first AlloDerm lawsuit was filed in May 2011. Since then, over 300 additional lawsuits have been filed in a Multi-County Litigation (MCL) in Middlesex County, New Jersey, overseen by Judge Jessica R. Mayer. Plaintiffs in the litigation allege that LifeCell knew or should have known as early as the 1990s that AlloDerm is defective.
Studies of AlloDerm and Hernia Repair
- Study published in the journal Hernia in 2008 found a complication rate of 24% among 70 AlloDerm patients, with recurrence of the hernia being the most common complication.
- Study published in 2011 by Hernia found that 37.9% of AlloDerm patients developed infections, and recurrent hernia occurred in 28.6% of patients.
In September 2005, LifeCell recalled AlloDerm after discovering that they were using tissues from a distributor who was not testing skin for certain diseases. According to LifeCell, the recall was issued because:
“Human tissues from donors, tested using diagnostic test kits rather than FDA licensed or cleared screening tests for hepatitis B surface antigen (HBsAg) and total antibody to hepatitis B core antigen (anti-HBc total), were distributed.”
AlloDerm Side Effects & Complications
- Chronic pain
- Inflammation, swelling
- Organ damage
- Adhesion failure
- Recurrent hernia
- Abscesses, hematoma, and seroma
- Mesh tear or perforation
- Mesh erosion
- Perforations in the patch caused by tissue weakness
- Post-operative bulging
- And more