LifeCell Corporation originally developed the AlloDerm Hernia Repair Patch as a graft for burn patients. It was intended to promote tissue growth in the areas where it was surgically inserted so that patient’s cells would effectively repopulate the treated area. It worked by putting human skin through a de-celling process, which resulted in collagen bio-product and a skin graft was made. This was done so that the body could incorporate the graft into its own blood vessels and tissues quickly. However later it was used for a variety of purposes including hernia repair surgery, breast reconstruction and dental work.

AlloDerm was made from donated human cadaver skin, removing all of the cells in the top layer and the entire dermis, leaving the collagen elastin framework of the skin. Some studies indicated that AlloDerm when used in hernia repair caused complications and resulted in a high rate of hernia recurrence. These studies also pointed out those hernia patients who were implanted with AlloDerm had the shortest follow- up period as compared to other hernia repair techniques. Injuries to nearby organs, nerves and blood vessels other than mesh and adhesion related issues were the common side effects associated with this repair patch. Though no deaths were reported, however, most of the people treated with AlloDerm had negative effects including painful surgeries involving mesh explants or removal of the graft. As per one of the studies conducted, approximately 8% of the AlloDerm patients had to undergo explants surgery compared to 1.6%.

The problems were divided into two categories:

The Device Related Problems

reported when used in hernia repair pointed to the health disorders that the mesh caused when used in curing hernia repair. The disorders that the graft caused were:

  • Ring Breakage:

    hernia recurrence, abdominal abscess, inflammation and swelling were reported in certain cases.

  • Mesh Tear:

    could result in hernia recurrence, infection and additional surgeries.

  • Mesh Perforations:

    weakness of tissue allowed the hernia to reoccur due to the perforations required for the preparation of this product.

  • Adhesion Issues:

    Many doctors reported failure of adhesion and proper healing of surgical incisions with the use of AlloDerm.

  • Mesh Erosion:

    Grafts like AlloDerm were commonly known for the risk of erosion. This left the patient with no option but to undergo further painful and expensive procedures.

AlloDerm was considered safe, until recently, when MedSun contributed to the FDA, 29 adverse event reports associated with 30 hernia mesh patches in 30 patients. This was done in between February 2007 to April 2009. There was plethora of companies which reported problems related to AlloDerm Hernia Repair Patch, namely:

  1. Covidien United States Surgical Corporation,
  2. Davol Inc. A subdivision of C.R. Bard, Inc.,
  3. Lifecell Corp.,
  4. Ethicon Inc.,
  5. Tissue Science Laboratory,
  6. Composix,
  7. Bard Urology Department, and
  8. Bard Access Systems.