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Corey S. Maas, MD; Douglas R. Gnepp, MD; Jeffery Bumpous, MD

Arch Otolaryngol Head Neck Surg. 1993;119(9):1008-1014.

Abstract
Background
Expanded polytetrafluoroethylene (EPTFE) (Gore-Tex soft-tissue patch) has received favorable clinical reports for use in facial augmentation procedures. We evaluated the EPTFE soft-tissue patch in short-term (3week), intermediate-term (6-month), and long-term (12month) animal models.

Methods
Nine pathogen-free male and female New Zealand white rabbits weighing 2 to 4 kg were used. After implantation of the EPTFE soft-tissue patch, the animals were carefully observed on a daily basis for signs of wound infection, seroma, or hematoma formation. The stability of the implant was evaluated and graded after the animals were killed. Tissue specimens, including skin, implant, and underlying bone, were removed en bloc. These blocks were sectioned and stained for histologic evaluation. A portion of these blocks were used for scanning electron microscopy.

Results
The material increased in stability over time and showed minimal inflammatory cell response and only a delicate fibrous capsule, even in long-term implants. Ultrastructural analysis demonstrated close apposition of the material to tissue, suggesting good interface bioactivity.

Conclusions
The EPTFE soft-tissue patch appears to be safe and reliable material for augmentation, demonstrating high biocompatibility, low tissue reactivity, and increasing stability over time.

(Arch Otolaryngol Head Neck Surg. 1993;119:1008-1014)

Author Affiliations
From the Division of Facial Plastic Surgery, Department of Otolaryngology, University of California, San Francisco (Dr Maas); Department of Pathology, Brown University, Providence, RI (Dr Gnepp); and Department of Otolaryngology, St Louis (Mo) University Medical Center (Dr Bumpous).

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