Implant with a visual indicator of a barrier layer

Abstract

An implantable soft tissue prosthesis device comprising a silicone elastomer-shell filled with silicone gel or liquid, which among the layers that constitute its shell includes a barrier layer formed of a low permeability silicone, which impedes the bleeding or diffusion of the silicone gel from the inside of the implant to its surroundings through the shell. This barrier layer is given a coloration different to the other layers of the shell, making it visible in the finished product. The coloration of the barrier layer gives the fabricator of the implant as well as to medical personnel, the possibility to identify the presence of the barrier layer and its homogeneity, improving the safety of the device.

1 . An implantable soft tissue prosthesis device comprising a multilayer shell of silicone elastomer formed with a mold, with a patch covering the aperture left from the molding process, which forms a lumen that can be filled with a fluid or a gel, wherein one layer of the shell is a low diffusion barrier layer and wherein said low diffusion barrier layer is given a color different to the other layers. 
     
     
         2 . An implantable soft tissue prosthesis device according to  claim 1 , wherein more than one low diffusion barrier layers are included in the shell. 
     
     
         3 . An implantable soft tissue prosthesis device according to  claim 1 , wherein the different color is given using a physical agent. 
     
     
         4 . An implantable soft tissue prosthesis device according to  claim 1 , wherein the different color is given using a chemical agent. 
     
     
         5 . An implantable soft tissue prosthesis device according to  claim 1 , wherein the layer with a different color is made with a material which itself has a color different to the other layers.