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An Interdisciplinary and International Approach to-ward an Alternative to Silicone Breast Implants
John C. Pedersen MD, FACS (1)
Judit E. Puskas, PhD (2), Goy Teck Lim, PhD (2)
M. Michelle Evancho-Chapman BS (3), Steven P. Schmidt PhD (3), Walter I. Horne DVM (3),
Stephanie A. Valente DO (3)
Ch
(1) Allure Aesthetics, Suite 350, One Park West, Akron, Ohio 44281
(2) Department of Polymer Scie
2010-03-31
Presenter: John C. Pedersen
Affidavit:
Director Name:
Author Category: Physician in Practice
Presentation Category: Basic Science Research
Abstract Category: Breast (Aesthetic and Recon.)
The incidence of breast cancer internationally is about 10%. One in eight American women will develop breast cancer. Of the 100,000 patients requiring mastectomy yearly as a consequence, 75% elect some form of breast reconstruction. Since 2006, only silicone breast implants have been approved for use by the FDA. Unfortunately, many women with these implants experience complications that may include capsular contracture, calcification, hematoma, and necrosis. Our group has been working on developing alternatives to silicone. The linear triblock poly(styrene-b-isobutylene-b-styrene) (SIBS) is a self-assembling nanostructured thermoplastic rubber, in clinical practice as a drug-eluting stent coating. The third generation with a branched (dendritic) core (Arbomatrix©) and its nanocomposites are promising structural materials offering an alternative to silicon rubber implant shells. The purpose of this preclinical research has been to evaluate tissue/material interactions in a rabbit implantation model. In a double-blinded 2-week rabbit study, there was no significant difference in tissue response between explanted Arbomatrix© and silicone rubber microdumbbells based on histological evaluation in six categories: acute and chronic inflammation, granulation tissue formation, foreign body giant cell reaction, fibrous capsule formation, and evidence of infection. The carbon nanocomposite of Arbomatrix© was also tested in a 6-month rabbit model implantation study. In soft tissues this had the thinnest tissue capsule around the microdumbbell specimens, with no eosinophiles present. The nanocomposite also showed excellent integration into bones. Future studies include the testing of antimicrobial and drug eluting coatings on implants.
