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R&D

Plastic surgery evolved from the need to reconstruct trauma defects, post-surgical defects and congenital defects. Two opposing approaches offer solutions for these needs – volume displacement and volume replacement. Before the introduction of fillers and implants, tissue displacement in the shape of various tissue flaps were used.

Once tissue fillers and implants have been introduced, tissue replacement techniques and devices became widely used. The introduction of silicone as tissue filler first for free injections and later on encased in silicone shells and the development of more advanced polymers or these uses made their use very common. Silicone made implants are used all over the body as first choice by surgeons.

Since their introduction in the ’60, breast implants have become the main pillar in breast surgery. Implants made aesthetic breast augmentation popular and common around the world. Most of breast reconstructions post mastectomies are done by tissue expanders and implants.

Silicone made implants have few shortcomings like the relatively high weight of the silicone with specific density of 1.1 gram/cc, ‘sweating’/’bleeding’ of silicone gel through silicone shells and migration of the free silicone into regional lymph basins, and capsular contracture around non-compressible implants resulting in pain and aesthetic disfigurement.

We, in ImpLite Ltd, have focused on solving the problems and shortcomings of silicone based soft tissue fillers and implants by employing novel technologies and ideas in designing and constructing a different type of device that will provide superior results without the known adverse effects of silicone made devices.

A multi-center perspective survey in Germany at the pathology institutes of the Dep. of Medicine at Ludwig Maximilian University (Munich, Germany) and the Park Hospital Weissensee (Berlin) determines the shapes, volumes and dimensions of the ESSENTIAL™ soft tissue filler.

The "FREEDOM™, the MAGIC™ and the ESSENTIAL™ implants are investigational devices and not commercially available in the USA.