Injectable collagen: a six-year clinical investigation

Area of Science:

• Dermatology
• Biomaterials Science
• Plastic Surgery

Background:

• Injectable bovine dermal collagen has been developed as a medical device.
• It is a sterile formulation of purified type I collagen in saline with lidocaine.
• This collagen filler is used for correcting cutaneous contour deficiencies.

Purpose of the Study:

• To evaluate the safety and efficacy of injectable bovine collagen.
• To assess adverse treatment reactions in patients receiving the collagen filler.
• To determine the long-term effectiveness of collagen injections for dermal contour elevation.

Main Methods:

• A 6 1/2-year investigation involving 5,109 patients.
• Data collected from 728 dermatologists and plastic surgeons.
• Analysis of adverse reactions and subjective efficacy assessments.

Main Results:

• An overall adverse treatment reaction incidence of 1.3% was observed.
• Most reactions were localized swelling and erythema.
• Data from an estimated 100,000 patients showed no increase in reaction rates post-FDA clearance.
• Subjective assessments indicated successful elevation of dermal contour defects.

Conclusions:

• Injectable bovine collagen is a safe and effective option for correcting dermal contour deficiencies.
• The material demonstrates a low incidence of adverse reactions.
• It is suitable for addressing defects from various etiological factors.