Injectable Collagen and a Rare Adverse Event—True Association or Artifact?
Collagen-based medical devices have been widely used in human soft tissue ranging from suture material to injectable dermatologic implants, and have a long history of safe and effective use. 1 Zyderm® and Zyplast® implants are forms of injectable bovine collagen (highly purified bovine dermal collagen, containing at least 95% Type I and < 5% Type III collagen in a fibrillar suspension of physiologic buffered saline and 0.3% lidocaine). Injectable collagen (Zyderm/Zyplast) is indicated for use in correction of contour deformities of the dermis in nonweight-bearing areas such as correction of distensible acne scars; atrophy from aging, disease, or trauma; and other soft tissue defects. Local complications, as determined in prospective trials of the safety and effectiveness of this device, include the low risk of infection that accompanies any transcutaneous procedure and a low level of a local hypersensitivity response (1–2% of treated patients). Anecdotal reports received postmarketing suggested that injection of Zyderm/Zyplast implants may be associated with an increased risk of a rare autoimmune disease, polymyositis/dermatomyositis (PM/DM). In addition, a report by Cuckier et al. (1993) 2 suggested that there may be a positive association between bovine collagen dermal implants and PM/DM. However, a critical evaluation of the available data by experts assembled by the Food and Drug Administration (FDA) concluded that there was “...insufficient statistical or biological evidence to support a conclusion that collagen injections cause autoimmune or connective tissue diseases in persons without a history of these diseases....” 3
KeywordsBackground Rate Bovine Collagen Rare Adverse Event Injectable Collagen Record Audit
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