[which] is [then] aseptically processed using LifeCell’s proprietary technique [in order] to remove the epidermis and cells that can lead to tissue rejection and graft failure. The [final product] is an intact acellular matrix of natural biological components that promotes rapid revascularization, white cell migration and cell repopulation, as shown in animal studies*” (LifeCell).
*Correlation of these results to results in humans is not established.
Regenerative Quality of AlloDerm
One of AlloDerm’s most important qualities is its ability to regenerate, resulting in a strong repair of damaged sections in hernia and breast reconstruction procedures. AlloDerm aids the regenerative process by providing a framework that facilitates the migration of new cells and blood vessels into the tissue “rather than triggering a scarring response. [Furthermore], AlloDerm® Regenerative Tissue Matrix allows [the body] to follow its own regenerative process—restoring tissue to its original structural, functional, and physiological condition. AlloDerm® Regenerative Tissue Matrix supports tissue regeneration…for a natural repair and clinically optimal outcome” (LifeCell).
Alloderm Specific Usage
According to the product’s manufacturer, AlloDerm is currently recommended for:
Gradually, more and more surgeons who perform penile enlargement procedures have turned to the use of AlloDerm . In penile enlargement procedures, surgeons attempt to increase the girth of the male penis by layering sheets of AlloDerm (usually 1 to 6 sheets), resulting in a greater penile shaft circumference.
Suitability of AlloDerm
While the regenerative properties of AlloDerm have benefited inguinal hernia and breast reconstructive procedures, the same properties may pose a high risk of failure if used in inappropriate locations of the body, including the penis.
The use of AlloDerm in penile enlargement procedures has resulted in many complications, including seromas, infections, and skin necrosis and loss. A failed neovascularization (growth of new vessels into the AlloDerm matrix) results in matrix loss, internal necrosis and skin damage. The simultaneous integration of the AlloDerm matrix into the shaft tissue and the overlying penile skin causes severe adhesion, leading to skin necrosis and loss. Furthermore, the inadequate number of AlloDerm sheets implanted provides only a relatively small gain in overall penis girth, which frequently decreases over time due to tissue absorption. Moreover, this tissue absorption results in an asymmetric penile appearance.
The complications and patient complaints noted include, but are not limited to:
- Asymmetric appearance of the penis
- Temporary, rather than permanent results
- Moderate to severe skin adhesion resulting in skin necrosis
- Severe and life threatening infections caused by the AlloDerm
Case #1: Acute, Severe AlloDerm Infection
Patient: 33-year-old Caucasian male with AlloDerm penile enlargement procedure performed one week prior to visiting our clinic. Presented with high fever, penis redness and swelling.
The patient was transferred to the operating room for immediate AlloDerm removal. During the procedure, the infected sheets (a total of 4) were removed and associated skin adhesions were released. The infected sheet had caused multiple necrotic skin areas, which were surgically removed and primarily closed.
After the initial recovery, two additional surgeries were needed to completely free the adhered skin from the shaft. Total recovery time was 7 months.
Case #2: Gradual diminution of AlloDerm sheets, resulting in temporary results
Patient: 47-year-old Caucasian male with AlloDerm penile enlargement procedure performed 8 months prior to visiting our clinic.
The patient requested that all AlloDerm sheets be removed and substituted with patented Elist soft silicone implant. He reported an initial girth increase of 0.75 inches after AlloDerm surgery, but which had now completely diminished due to tissue absorption. As a result of absorption, the penis appeared asymmetric.
During the first procedure, in which the AlloDerm sheets were removed and skin adhesions were released, it was determined that the strongly vascularized AlloDerm had left the skin damaged internally insofar that further surgery was postponed for one year in order to evaluate future skin conditions.