I wanted to begin to compile some data of the effectiveness of Alloderm PE. Since Dr.Whitehead listed his complication experience on his site I decided to use his data to begin to get a sense of complication rates. I got over 1000 but less than 2000 for the number of cases after speaking to a consultant. I will use 1000 as the number but will update if I get more details.
Adverse Effect Number of Cases (1000 total)
Loss of upward angle 2
Scarring, loss of length 0 (with use of a stretching device)
Absorption loss of thickness 1 (partial with some loss)
Contracture /Separation 3
Failure to take 0
Skin incision separation 10* (a few temporary is the exact quote)
Loss of penile skin NA* (quote is this rarely occurs)
Bleeding 1 (collection of blood under skin, easily managed)
Fibrosis of superficial vein NA* (rarely occurs and usually resolves by itself)
Infection 7 (3 lost the graft, 1 partial lost, 3 did not lose graft)
Ecchymosis NA* (rarely occurs and usually resolves by itself)
Nerve injury 0
Edema (Temporary) NA* (occasionally seen in patients)
Erectile Dysfunction 0
Complication rate of all adverse effects: (24/1000) or 2.4% (*includes a swag of 10 for incision separation).
Total Infections: (7/1000) or 0.7%,
Infection caused Lost Graft: (4/1000) or 0.4%
Total Grafts Lost: (8/1000) or 0.8% (including partial loss or contracture or separation)
I was extremely surprised by the low rate of adverse effects. I had expected something 10 times higher. These results lead me to question both the number of cases and or the accuracy of the adverse effects reported.
For comparison a study of the most controversial current usage of Alloderm, in Abdominal Hernia Repair, shows a (14/70) or 20% complication rate with 1 rejection (1.5%), 2 infections (2.9%), and 14 recurrences.