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Abstract

An implantable prosthetic device having a biocompatible elastomeric shell and a polyphasic filler material consisting of gas-filled chambers or beads bathed in a biocompatible fluid. In a preferred embodiment the solid and gaseous phases of the filler comprise interconnecting flexible chains of small gas-filled beads. The gas-filled beads may be continuously extruded in a chain with a fiber of extrudate connecting the beads. In one embodiment, the extruded chains of beads are formed into a mass having the desired shape of the prostheses where they may be further crosslinked, then placed within an outer shell. The void space between the beads is filled with a biocompatible fluid such as saline. The polyphasic filler preferably has a density which is less than or equal to the density of the surrounding tissue thereby reducing microtrauma to the capsule associated tissue and the incidence and/or severity of capsular contracture. The prosthesis does not collapse, wrinkle or otherwise become deformed during use; even in the case of rupture. In another embodiment, gas-filled beads are injected endoscopically into a previously placed, fluid-filled implant to displace the liquid filler and alter the density of the filler. The effective density of the polyphasic filler can be adjusted by varying the ratio of the volume of encapsulated gas to the weight of the encapsulating solid phase.

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First Claim