| 摘要 |
An elastomeric gel-filled prosthetic implant (10) having a shell made of a single gel barrier layer. The barrier layer (14) is formed of a homogeneous silicone elastomer capable of sterically retarding permeation of the silicone gel through the shell and having a bleed rate that is less than about 40% of. the bleed rate of current shells which use a sandwiched construction with an internal barrier layer. Further, the barrier layer shell is made of a material that exhibits a wet strength that is comparable to or greater than current shells. The silicone elastomer may be a polydimethyl siloxane, and the substituted chemical group is a diphenyl group with a minimum mole percent of at least 13%. The implant may be designed for breast reconstruction or augmentation such that the shell is accordingly shaped. The shell wall thickness is at least 0.254 mm (0.010 inches), and desirably about 0.456 mm (0.018 inches). The implant shell may be made by dip-forming, spray- forming, or rotational molding. The exterior may be smooth or textured. |
