Gravity sensitive silicone breast implants

Abstract

A gravity sensitive silicone breast implant is provided which, in various embodiments, has a soft, natural feel and adapts shape after implantation responsive to gravity, according to movements of the patient.

1 . A gravity sensitive silicone breast implant, comprising a flexible multilayer shell and a cohesive silicone gel filler with a high elasticity and a low viscosity, and configured to shift its maximum point of projection when subjected to gravity, wherein the flexible multilayer shell reaches at least 25% elongation at forces of about 1.4 N to about 1.9 N and at least 50% elongation at forces of about 1.8 N to about 2.2 N when tested in accordance with ASTM D412, and wherein the silicone gel filler reaches about 2 mm to about 29 mm protrusion in a cone cohesion test and will not detach from the cone when tested in accordance with ASTM F703. 
     
     
         2 . The gravity sensitive silicone breast implant of  claim 1 , wherein the flexible multilayer shell has a nano-textured outer surface. 
     
     
         3 . The gravity sensitive silicone breast implant of  claim 1 , wherein the flexible multilayer shell has a micro-textured outer surface. 
     
     
         4 . The gravity sensitive silicone breast implant of  claim 1 , wherein the flexible multilayer shell has a thickness of about 0.008 in to about 0.030 in. 
     
     
         5 . The gravity sensitive silicone breast implant of  claim 1 , wherein the flexible multilayer shell includes at least one low diffusion barrier layer. 
     
     
         6 . The gravity sensitive silicone breast implant of  claim 5 , wherein the low diffusion barrier layer comprises a polysiloxane backbone having at least 10 mole percent of a pendant chemical group that retards permeation of silicone gel through the low diffusion barrier layer. 
     
     
         7 . The gravity sensitive silicone breast implant of  claim 5 , wherein the low diffusion barrier layer comprises a polydimethylsiloxane backbone having at least 10 mole percent of a pendant chemical group comprising at least one of a phenyl group and a fluorine group. 
     
     
         8 . The gravity sensitive silicone breast implant of  claim 5 , wherein the low diffusion barrier layer comprises a polydimethylsiloxane backbone having at least 10 mole percent of a pendant chemical group comprising at least one of a diphenyl group, a methylphenyl group, a trifluoropropyl group, and mixtures thereof. 
     
     
         9 . The gravity sensitive silicone breast implant of  claim 5 , wherein the low diffusion barrier layer has a color. 
     
     
         10 . The gravity sensitive silicone breast implant of  claim 1 , wherein the implant has a round base. 
     
     
         11 . The gravity sensitive silicone breast implant of  claim 1 , wherein the implant has an oval base.