Factors affecting the rupture of silicone-gel breast implants.

Between January 1990 and April 1993, over 500 patients with silicone-gel breast implants were clinically assessed regarding their implant status. Of these, 57 patients requested implant removal. Reasons for removal were capsular contracture (39 patients), possible implant rupture, suggested by ultrasound testing or mammography (7 patients), "silicone phobia" (7 patients), and asymmetry (4 patients). Of the 102 implants that were removed, 60% were intact, 33% were ruptured, and 7% were leaking. There was a positive correlation between duration of implantation time and the number of ruptured and leaking implants. Of the 45 implants that had been in place for 5 years or less, 93% were intact. Of the 29 implants that had been in place for 6 to 10 years, only 31% were intact (59% were ruptured and 10% were leaking). Similar results were obtained in 20 implants after 11 to 15 years (30% were intact, 55% were ruptured, and 15% were leaking). Of 8 implants that were in place for 16 to 26 years, 50% were intact and 50% were ruptured. In this study, the integrity of breast implants was not related to the degree of capsular contracture.