What is Macroplastique® / Plastique®?
Macroplastique® Implants is a sterile, nonpyrogenic, latex-free, injectable tissue bulking agent comprised of flexible, soft textured implants of heat-vulcanized polydimethylsiloxane (a solid silicone elastomer) suspended in a bio-excretable polyvinylpyrrolidone (PVP) carrier gel. When implanted in the urethral wall between the mid-urethra and the bladder neck, the implants bulk tissue and create coaptation of the urethra.
Macroplastique is supplied sterile in a pre-filled polypropylene syringe containing approximately 2.5 ml of product. The Macroplastique product is implanted using an administration device and an endoscopic injection needle recommended by Laborie Medical.
Macroplastique is a biocompatible, nonresorbable implant that allows tissue healing to occur. The synthetic implants remain in place at the implantation site as a result of the naturally occurring tissue response. The carrier gel is exchanged for tissue fluids containing host fibroblasts that subsequently deposit a collagen matrix around the individual implants, as well as around the periphery of the implanted material. After the exchange, the carrier gel is removed by the reticuloendothelial system and excreted unmetabolized from the body through the kidneys.
Macroplastique should only be used by someone properly trained in diagnostic and therapeutic cystoscopy.