Abstract

Research and development of breast implant manufacturing technology continues with the dual objectives of finding better processes for manufacturing implant shells and finding better filler solutions or gels. The Mentor HIS manufacturing process exemplifies improved techniques of implant shell production and quality control. The process is described in detail, and the Mentor HIS and McGhan processes of manufacturing breast implants are compared. Recognized shell weaknesses include thin spots, valve malfunction, rupture because of overfilling, and folding and leakage because of underfilling. All implants are inspected. Smooth implants are inspected 22 times while textured implants are inspected 23 times.

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