Mcghan Medical Corporation

Allergan, Inc.

Moghan Medical Corp.

Daniel A Carlisle

G Patrick Maxwell

Richard S Waybright

Thomas E Powell

Blanca Guillen

Patrick G Maxwell

A variable cohesive gel form stabilizing implant is provided for augmentation or reconstruction of the breast. The prosthesis includes a shell filled with a gel having variations in cohesiveness to maintain stable form, shape, and dimension after surgical implantation.

Variable cohesive gel form-stable breast implant

A variable cohesive gel form stabilizing implant is disclosed for augmentation or reconstruction of the breast. The prosthesis of this invention comprises an implantable shell or envelope (not limited to a single shell or envelope), filled with a biocompatible gel, or gels, having alterations in gel cohesiveness to maintain stable form, shape, and dimension after surgical implantation. The gel cohesiveness may increase, with increased volume or dimension of the prosthesis. The variable cohesiveness of the gel filler material may be altered by any means (i.e. chemical, fabrication, etc.). The variable cohesive gel form stabilizing implant has shape retention characteristics to maintain its form, thereby reducing or eliminating the undesirable effects of shell wrinkling, knuckling, scalloping or deformation, which can occur at the upper or lower pole of the prostheses, along the perimeter of the shell or at the base, post-implantation. Finally, the variable cohesive gel form stabilizing implant provides new control and possibilities for achieving and preserving the most natural breast shape.

A breast prosthesis for implantation beneath the skin is disclosed. In one preferred embodiment the prosthesis has an outer elastic shell which encloses a biocompatible fluid and a silicone foam insert of unitary construction having the shape and approximate consistency of breast tissue. The foam insert occupies substantially the entire volume enclosed by the shell of the implantable prosthesis and consists of a foam body that is molded to the shape of the breast. The foam body has both open-cell and closed-cell characteristics. Portions of the foam insert are closed-cell with open-cell passageways threading themselves throughout the structure. The insert is of unitary construction and made by (a) heating a mold to an appropriate temperature; (b) mixing air bubbles into a dispersion of uncured silicone; (c) injecting the bubble-laden, uncured silicone into the preheated mold; and (d) applying a vacuum until the foam insert cures. The volume of the foam insert should preferably be substantially equal to the unstretched volume of the shell which surrounds the foam body. In another preferred embodiment only a portion of the volume enclosed by the shell is occupied by the foam insert. In this embodiment, one surface of the foam insert conforms to the curvature of at least a portion of the shell and may be affixed to the conforming inner surface of the shell thereby effectively thickening or reinforcing the overlying shell. In yet another embodiment a foam insert made as described above comprising an open-cell and closed-cell foam body may be directly implanted beneath the skin for breast augmentation or reconstruction without a shell. The inner surface of the mold may be textured to provide additional opportunity for desirable tissue ingrowth following implantation.

Molded silicone foam implant and method for making

A fluid-filled mammary prosthesis for implantation beneath the skin of a patient comprising a shell and an adjunctive filler. The shell is preferably a closed silicone elastomer envelope having an interior volume and valve for filling. The filler material is a mixture of a fluid such as saline and an adjunct consisting of a plurality of hollow silicone beads having two or more fenestrations within the wall of each bead which provide fluid communication between the outside of the bead and the hollow interior. The beads are packed into the shell prior to the introduction of fluid into the interior of the shell. The beads serve as a baffle to prevent unwanted hydraulic behavior of the fluid portion of the filler material and also serve to help maintain the anatomical profile of the implant. The hollow beads, which range in size from about 7/32 inch to 1/2 inch in inside diameter, may be conveniently made by injection molding. The adjunctive filler may be a plurality of beads of a particular size or a mixture of different sized beads.

Adjunctive filler material for fluid-filled prosthesis

A fluid-filled breast prosthesis for surgical implantation beneath the skin having a wrinkle resistent, elastic outer shell which is adapted to resist deformation or wrinkling during movement of the fluid filler. The outer shell, or envelope, has superior and inferior portions. The wall of the superior portion of the shell is substantially thickened with respect to the wall thickness of the inferior portion of the shell. The shell forms an envelope with an inner cavity which is filled with a biocompatible liquid such as saline. The presence of the thickened superior portion of the shell prevents wrinkles from forming in the breast prosthesis during fluid displacement such as occurs when the breast prosthesis recipient changes her anatomical position. The differentially thickened shell has a posterior base portion which may be reinforced to further stabilize the prosthesis.

Shape-retaining shell for a fluid filled prosthesis

A breast prosthesis for implantation beneath the skin is disclosed. In one preferred embodiment the prosthesis has an outer elastic shell which encloses a biocompatible fluid and a silicone foam insert of unitary construction having the shape and approximate consistency of breast tissue. The foam insert occupies substantially the entire volume enclosed by the shell of the implantable prosthesis and consists of a foam body that is molded to the shape of the breast. The foam body has both open-cell and closed-cell characteristics. Portions of the foam insert are closed-cell with open-cell passageways threading themselves throughout the structure. The insert is of unitary construction and made by (a) heating a mold to an appropriate temperature; (b) mixing air bubbles into dispersion of uncured silicone; (c) injecting the bubble-laden, uncured silicone into the preheated mold; and (d) applying a vacuum until the foam insert cures. The volume of the foam insert should preferably be substantially equal to the unstretched volume of the shell which surrounds the foam body. In another preferred embodiment only a portion of the volume enclosed by the cell is occupied by the foam insert. In this embodiment, one surface of the foam insert conforms to the curvature of at least a portion of the shell and may be affixed to the conforming inner surface of the shell thereby effectively thickening or reinforcing the overlying shell. In yet another embodiment a foam insert made as described above comprising an open-cell and closed-cell foam body may directly implanted beneath the skin for breast augmentation or reconstruction without a shell. The inner surface of the mold may be textured to provide additional opportunity for desirable tissue ingrowth following implantation.

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Santa Barbara, CA, United States of America

Daniel A Carlisle