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Alloderm Hernia Patch Product Liability Lawsuits


AlloDerm Hernia Patch Product Liability Lawsuits AlloDerm is a surgical mesh that has been widely used in hernia repair surgeries, which is the surgery most frequently performed by general surgeons in the United States. Hundreds of thousands of abdominal wall hernias are repaired every year.

Marketed and sold since 1994 by LifeCell, it is “decellularized human cadaveric dermis,” meaning that it is donated human skin. This donated skin goes through an intricate process to take out the top layer of cells and the dermis but leaving intact the collagen and other components the mesh needs. It is also successfully used in breast reconstruction after mastectomy.

The product is supposed to promote tissue growth and has worked wonders for many people. There is no question about that. But scientific studies are continuing to come out showing an extremely high rate – unacceptably high rate – of complications and problems. Ultimately, the use of Alloderm or really any of the biological meshes is a tension-free or bridge repair. These products have been had a large number of hernia recurrences. Why? As a biological, they simply disappear over time and recreate a big defect that could not be closed primarily.

Alloderm Defects

Medical journals have reported problems with AlloDerm for a long time. In 2008, the journal Hernia reported in Results of AlloDerm Use in Abdominal Hernia Repair that AlloDerm hernia patches failed at an alarming rate – up to 24% at one hospital.

Surgery Malpractice

The most frequent problem is the recurrence of a hernia, meaning that the patch was unable to restrain the herniated tissue over time and that a second surgery would likely be required. Other problems included infection and a rejection of the AlloDerm by the body. Some studies since then have shown an even higher rate of failure for AlloDerm hernia surgeries. It is clear that the manufacturer failed to conduct appropriate long-term studies on AlloDerm before selling it to the public.

Alloderm Hernia Patch Injuries

The AlloDerm hernia patch can cause a number of injuries, including:

  • pain and swelling
  • mesh tears or erosion
  • abscess and infection
  • reoccurrence of the hernia
  • additional surgeries

Alloderm Hernia Patch Lawsuits

Plaintiffs have filed lawsuits in these cases alleging that LifeCell failed to conduct sufficient testing and analysis of AlloDerm to determine its appropriateness for use in hernia repairs and ventral repairs in particular. Because AlloDerm is a type of soft tissue graft known as reconstructive tissue matrix, that is made from minimally processed human cadaver skin, less testing was required by federal law. But that does not absolve LifeCell from the obligation to make a safe product.

There is a collection of AlloDerm hernia patch lawsuits pending in New Jersey state courts, where the manufacturer is located. Many have been filed before Judge Carol Higbee in Atlantic County, and these lawsuits have now been combined into a “sort of” class action lawsuit under Judge Higbee. Why sort of? The cases are not a pure class action but have some characteristics of class action lawsuits. Most importantly, the judge monitors all of them, arrange for unified and non-duplicative discovery, and can even promote settlements.

New Jersey courts are considered good by plaintiffs’ lawyers in product liability cases, and any person who was injured by Alloderm can file a lawsuit there. It is possible that there will be an effort to unify Alloderm federal lawsuits in the same way.

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