STRENGTH OF SILICONE BREAST IMPLANTS

Rupture and leakage are recognized problems associated with silicone b reast implants. Data are scarce about the durability of the silicone s hell, and the life span of this device is unknown. The purpose of this study was to investigate the strength of silicone breast implants. Th irty implant shells were subjected to mechanical testing. Twenty-nine of the shells were tested after explantation, and one unused implant s erved as a control to validate the testing method. Implantation time v aried from 4 months to 20 years, and all shells were tested, regardles s of condition. Fourteen implant shells were intact, eight were leakin g, and seven were ruptured. All ruptured implants had been in place fo r 10 years or longer. The breaking force of all excised shell specimen s ranged from 2.6 to 22.4 N (0.6 to 5.0 Ib). Specimens from the contro l ''high performance'' shell required 15.5 to 25.6 N (3.5 to 5.8 Ib) o f force to fail. The weakest group was from thin-shelled implants betw een 10 and 16 years of age. More than half these specimens failed with less than I. Ib of force. The average breaking force of ruptured shel l material was less than that of intact shells. A comparison of streng th data in this study with manufacturers' data suggests that breaking force is dependent on implant type, shell thickness, and implantation time.