Device for inhibiting the formation of fibrous capsular contractures in silicone breast implants and method

• US 4,298,997 A
• Filed: 10/23/1979
• Issued: 11/10/1981
• Est. Priority Date: 10/23/1979
• Status: Expired due to Term

• Current Assignee: Rybka F. James
• Original Assignee: Rybka F. James
• Inventors: Rybka, F. James
• Primary Examiner(s): Crowder, Clifford D.
• Application Number:
  US06/087,326
• Time in Patent Office: 749 Days
• Field of Search: 3/36, 128/DIG. 21
• US Class Current: 623/8
• CPC Class Codes: A61F 2/12 Mammary prostheses and implants
• CPC Class Codes: A61L 27/14 Macromolecular materials

Abstract

A circular disc of thin silicone sheet material, such as Silastic, is adhesively attached to an annular band of Dacron felt material, the periphery of the disc and the outer rim of the Dacron felt band being substantially congruent. The combined disc and band are surgically implanted, preferably beneath the chest muscles, with the Dacron felt band against the rib cage. A conventional breast implant having substantially the same diameter as the circular disc is then placed over the disc in register therewith and the incision closed. The arrangement not only gives the surgeon freedom of choice in selecting the implant size and configuration but also reduces the incidence of problems arising from the formation of fibrous capsular contractures in silicone breast implants.

Claims

1. Device for inhibiting the formation of fibrous capsular contractures in surgically installed breast implants comprising:

a. a disc of thin flexible impervious, sheet material, said disc having a shape in plan approximately the same as the shape in plan of the implant; and

,

b. a band of material secured to said disc in congruent marginal edge relation, said band being porous to permit the ingrowth of subjacent tissue from the rib cage and said disc being in unattached engagement with the implant overlying said disc in substantially symmetrical relation in plan as the incision resulting from the surgical installation is closed.

2. A device as in claim 1 in which said disc is circular in plan and said band is annular in plan.

3. A device as in claim 2 in which said disc is of Silastic sheeting having a thickness of about 0.18 mm., and said band is of Dacron felt material approximately 1.5 cm. wide.

4. A device as in claim 3 in which said band is secured to said disc by silicone adhesive.

5. A method for inhibiting the formation of fibrous capsular contractures in breast implants comprising the steps of:

a. providing a circular disc of thin, flexible, impervious, bio-compatible sheet material and an annular band of porous bio-compatible material secured to the disc in congruent relation;

b. surgically installing the combined disc and band subpectorally with the band facing the rib cage;

c. positioning a breast implant above the disc in symmetrical relation;

d. covering the implant with the pectoral muscle and breast tissue; and

,

e. closing the incision.

6. A method as in claim 5 in which the disc is of sheet Silastic and the band is of Dacron felt.