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AlloDerm Hernia Repair Failure Lawyers
Alloderm Hernia Repair Failure and Medical Device Lawsuits
There has been no FDA recall for AlloDerm hernia repair biologic mesh since 2005. At that time LifeCell Corporation of Branchburg, New Jersey proceeded with a voluntary recall of certain AlloDerm, Repliform, and GraftJacket products. The AlloDerm recall was prompted when internal quality processes raised questions about the donor documentation received from one tissue recovery organization.
Specifically, the company recalled all lots of product that were produced using tissue from Biomedical Tissue Services (BTS). LifeCell promptly notified the FDA and all relevant hospitals and medical professionals.
All other BTS inventory remained on hold until the discrepancies in the donor documentation could be resolved.
According to some recent studies three patients had the mesh placed in a contaminated field with no resultant sequela, and there were no hernia recurrences. Patients also had a significant degree of discomfort and pain during the immediate post-operative period. The use of the AlloDerm mesh resulted in eight hernia recurrences. Fifteen of 33 Alloderm patients developed or bulging at the repair site. Post-operative bulging and hernia recurrence was a major problem with the AlloDerm mesh. Further design improvements are required for these new mesh products. Surgeons should be aware of these potential complications prior to the selection of products and the patient should be informed and educated accordingly.
Even with these known AlloDerm problems, the FDA has not recalled AlloDerm nor has it sent out any warning communications. The FDA remains in a let's wait and see mode.
Contact an AlloDerm Lawyer
Have you or a loved one experienced serious side effects from a failed hernia repair caused by Alloderm or another kind of mesh patch? If the answer is yes— please contact a medical device product negligence lawyer who can help you determine if you qualify for a hernia repair lawsuit.