New biomaterial as a promising alternative to silicone breast implants

J Mech Behav Biomed Mater. 2013 May:21:47-56. doi: 10.1016/j.jmbbm.2013.01.025. Epub 2013 Feb 9.

Abstract

One in eight American women develops breast cancer. Of the many patients requiring mastectomy yearly as a consequence, most elect some form of breast reconstruction. Since 2006, only silicone breast implants have been approved by the FDA for the public use. Unfortunately, over one-third of women with these implants experience complications as a result of tissue-material biocompatibility issues, which may include capsular contracture, calcification, hematoma, necrosis and implant rupture. Our group has been working on developing alternatives to silicone. Linear triblock poly(styrene-b-isobutylene-b-styrene) (SIBS) polymers are self-assembling nanostructured thermoplastic rubbers, already in clinical practice as drug eluting stent coatings. New generations with a branched (arborescent or dendritic) polyisobutylene core show promising potential as a biomaterial alternative to silicone rubber. The purpose of this pre-clinical research was to evaluate the material-tissue interactions of a new arborescent block copolymer (TPE1) in a rabbit implantation model compared to a linear SIBS (SIBSTAR 103T) and silicone rubber. This study is the first to compare the molecular weight and molecular weight distribution, tensile properties and histological evaluation of arborescent SIBS-type materials with silicone rubber before implantation and after explantation.

MeSH terms

  • Animals
  • Biocompatible Materials / chemical synthesis*
  • Biocompatible Materials / toxicity*
  • Breast Implants / adverse effects*
  • Equipment Failure Analysis
  • Female
  • Mammary Glands, Animal / pathology*
  • Mammary Glands, Animal / surgery*
  • Materials Testing
  • Molecular Weight
  • Prosthesis Design
  • Rabbits
  • Silicone Elastomers / chemistry
  • Styrenes / chemistry*
  • Styrenes / toxicity*
  • Tensile Strength

Substances

  • Biocompatible Materials
  • Silicone Elastomers
  • Styrenes
  • poly(styrene-b-isobutylene-b-styrene)