A response to "Major complications associated with xenograft biologic mesh implantation in abdominal wall reconstruction" (Harth KC, Rosen MJ. Surg Innov. 2009;16:324-329) and discussion of the MAUDE (manufacturer and user facility device experience) database, FDA regulation of biologic implants, and evidence-based medicine.
Ross David
RD
Segan
D034861:Abdominal Wall / Q000601:surgery*; D019992:Databases as Topic; D006801:Humans; D019651:Plastic Surgery Procedures; D013526:Surgical Mesh / Q000009:adverse effects*; D014183:Transplantation, Heterologous / Q000009:adverse effects*