AlloDerm Hernia Patch Side Effects and Injuries
Individuals throughout the United States who received AlloDerm Regenerative Tissue Matrix during hernia repair may have suffered serious and debilitating health problems as a result of inadequate warnings and instructions provided by the manufacturer.
First introduced in the early 1990s, LifeCell Corporation has marketed AlloDerm for a variety of uses, including as a skin graft for plastic surgery and burn victims, during periodontal surgery, abdominal reconstructive surgery and as a mesh patch for hernia repair.
Most of the serious AlloDerm problems reported stem from use of the device as a hernia mesh or during abdominal repair, because LifeCell recklessly marketed the product without properly evaluating the risk of side effects, or warning about the potential for serious injury if the AlloDerm patch is not “pre-stretched”.
The AlloDerm hernia mesh lawyers at Saiontz & Kirk, P.A. are no longer reviewing new claims for individuals who experienced problems following AlloDerm hernia repair. This page is maintained for informational purposes only.
ALLODERM PROBLEMS AS HERNIA MESH
When AlloDerm is not “pre-stretched” or implanted under significant tension to remove laxity, the surface area of the graft can increase by 30-50%. This may cause the hernia patch to stretch, expand, thin out, pull, sag, loosen, spread or dissolve, resulting in:
- Hernia Recurrence after AlloDerm Surgery
- Abdominal Deformity
- Abdominal Pain and Overall Sickness
- Continuing Disability
AlloDerm is comprised of allograft human tissue, which is harvested from cadavers of people who donated their organs. The tissue is then stripped of the epidermis and cells, and then it is freeze dried to remove moisture and form a uniform allograft that is white colored.
The process of transforming human tissue into AlloDerm does not remove the elasticity, which allows the mesh to stretch like human skin. However, when AlloDerm is used for hernia repair, this may cause serious problems when AlloDerm stretches out over time, which is the reason many users have filed injury complaints after use of the device as a hernia patch.
When LifeCell began actively promoting the product for hernia repair, they failed to warn about these AlloDerm problems. Instructions provided with the product when the company was first marketed AlloDerm as hernia mesh failed to provide any specific reference, instruction or warning to “pre-stretch” AlloDerm. The manufacturer also continued to benefit from increased sales of AlloDerm for hernia repair, without informing surgeons that if the patch is pre-stretched, it will increase in size, allowing them to purchase smaller pieces of the graft.
To avoid problems from AlloDerm following hernia repair, it is necessary for surgeons to suture AlloDerm under significant tension to ensure the laxity is removed as much as possible. Removing laxity in this way will increase the surface area of each graft by 30-50%.
LAWSUITS FOR ALLODERM INJURY SIDE EFFECTS
AlloDerm is classified as banked human tissue, which means that it has not been cleared or approved by the FDA. LifeCell marketed Alloderm as safe and effective for hernia repair, suggesting that it was more effective than other hernia repair problems. While marketing that AlloDerm provides the natural elasticiy of human skin, they failed to warn about the risk of side effects.
As early as 1994, LifeCell knew or should have known that Alloderm is defective, dangerous to human health, unfit and unsuitable to be marketed and sold for hernia repair or abdominal reconstructive surgery, and lacked proper warnings and instructions about the problems associated with use. The manufacturer continued to profit from sales of AlloDerm for hernia repair, ignoring reports that users were likely to suffer a serious injury when the AlloDerm patch failed.
As a result of LifeCell’s decision to place their desire for profits before consumers safety, financial compensation was pusued through AlloDerm injury lawsuits. New cases are no longer being accepted. This page is maintained for informational purposes only.