Reinforced prosthetic implant with flexible shell

Abstract

A fluid-filled soft prosthetic implant having a shell with a reinforced shell wall. The soft prosthetic implant may be for breast reconstruction or augmentation, or to restore the normal appearance of soft tissue in the buttocks, chin, calf, etc. The implants may be reinforced using several methods: reinforcement of the shell wall, non-homogeneous gel-filling, or both. At least a portion of the perimeter region desirably has a shell wall thickness greater than the average shell wall thickness of either the anterior face or the posterior face. The added material at the perimeter region strengthens that area in which a large percentage of implant ruptures occur. The reinforced perimeter also helps prevent the implant from collapsing or folding, which can cause undesirable rippling or wrinkling visible through the patient's skin. The remainder of the shell will desirably have a nominal wall thickness to retain the overall softness and supple feel of the implant. The implant shell may be filled with gels of different gel cohesiveness to counterbalance any reinforced area or to provide added reinforcement.

What is claimed is: 
     
         1 . A method of making a prosthetic implant, comprising:
 forming a hollow shell having a generally oval vertical cross-section with a first face opposed to a second face and separated by a perimeter region;   introducing a first silicone elastomer gel into the hollow shell;   causing the first silicone elastomer gel to distribute generally evenly around and in contact with the perimeter region of the hollow shell;   introducing a second silicone elastomer gel into the hollow shell and in contact with the cured first silicone elastomer gel, the second silicone elastomer gel having a different softness than the first silicone elastomer gel;   curing the first and second silicone elastomer gels in the hollow shell; and   removing the hollow shell from the mold cavity and filling the hollow shell with a third silicone elastomer gel to obtain the gel-filled prosthetic implant.   
     
     
         2 . The method of  claim 1 , wherein the second silicone elastomer gel has a lesser gel cohesiveness than the first silicone elastomer gel. 
     
     
         3 . The method of  claim 1 , wherein the second silicone elastomer gel has a greater gel cohesiveness than the first silicone elastomer gel. 
     
     
         4 . A prosthetic implant made by the method of  claim 1 . 
     
     
         5 . A method of making a breast implant, comprising:
 forming a hollow shell having a generally oval vertical cross-section with a first face opposed to a second face and separated by a perimeter region;   introducing a first silicone elastomer gel into the hollow shell;   causing the first silicone elastomer gel to distribute generally evenly around and in contact with the perimeter region of the hollow shell;   introducing a second silicone elastomer gel into the hollow shell and in contact with the cured first silicone elastomer gel, the second silicone elastomer gel having a different softness than the first silicone elastomer gel;   curing the first and second silicone elastomer gels in the hollow shell; and   removing the hollow shell from the mold cavity and filling the hollow shell with a third silicone elastomer gel to obtain the breast implant.   
     
     
         6 . The method of  claim 5 , wherein the second silicone elastomer gel has a lesser gel cohesiveness than the first silicone elastomer gel. 
     
     
         7 . The method of  claim 5 , wherein the second silicone elastomer gel has a greater gel cohesiveness than the first silicone elastomer gel. 
     
     
         8 . A breast implant made by the method of  claim 5 .