FDA Information on AlloDerm Hernia Repair Patch
FDA classified LifeCells AlloDerm Dermal Tissue as “BANKED HUMAN TISSUE”. FDA had sent a written notification to LifeCell corporation on 23rd September 1996, stating that AlloDerm’s preserved human dermis used for transplantation be classified as “banked human tissue” and not as a medical device.
Paul Frison, president of LifeCell Corporation issued a statement mentioning FDA’s consent on the fact that AlloDerm preserved human dermis- which is a tissue graft intended for transplantation, is not a medical device and should be regulated as “banked human tissue”. The decision was followed by a review of all the clinical data and journal articles provided by LifeCell to FDA. FDA mainly addresses the clinical use of AlloDerm in the treatment of third-degree burns, plastic and reconstructive surgery and periodontal surgery.
In November 1995, when LifeCell introduced AlloDerm commercially, for periodontal applications, FDA notified the manufacturers once more, to consider the graft as a medical device, unlike earlier, where the notifications were not to treat it as medical device. Post this notification LifeCell constantly kept FDA in loop and provided all the data to support FDA’s opinion that AlloDerm dermal tissue should be regulated as banked human tissue.
The overall complication rate of AlloDerm Hernia Repair Patch was as high as 24%. In comparison with the control groups, 8% of AlloDerm patients required explants surgery whilst 1.6% in control groups. Most of the complications associated with AlloDerm have the potential to require additional, painful surgeries, mesh explants being the most frequent and common. Mesh explants mainly had to be carried out due to fluid accumulation following implantation of the graft. In a study of 70 patients who were administered AlloDerm Hernia Repair Patch, one experienced rejection, two suffered from infections, and 14 other patients had hernia recurrence.
On 30th September 2005, LifeCell initiated a voluntary recall of certain AlloDerm products from the market place. The recall was prompted due to quality issues on donor documentations received from one of the tissue recovery organizations. “Biomedical Tissue Services (BTS)” was one of the organizations in specific, whose manufactured products were under scrutiny and had major quality lapses. FDA, all the medical hospitals and professionals were notified at once, about this finding, and all the other BTS inventory was held till the discrepancies in donor documentation was resolved. LifeCell worked with 40 other organizations which were not affected by this recall.
AlloDerm (intended use for replacement or repair of damaged or inadequate integumental tissue, including gingival dermis) was announced as a banked human tissue in a letter dated 17th September 1996, by the FDA’s Chief Mediator and Ombudsman in the Office of the Commissioner. The notification even mentioned that FDA will consider all the AlloDerm cases individually which involve usage of the graft other than transplantation. AlloDerm products addressed multiple clinical markets including the treatment of third- degree burns, periodontal surgery and plastic and reconstructive surgery. AlloDerm has been used to treat almost over 2,500 patients since its introduction in 1994.