An analysis of silicone gel-filled breast implants: Diagnosis and failure rates

This retrospective review analyzed 180 women who underwent explantation of 357 silicone gel-filled breast implants from September of 1991 to January of 1995. Implant status, including shell integrity and implantation times, was determined at the time of explantation. The age range of the patients was 25 to 75 years, with a mean age of 47 years. The age of the implants ranged from 0.5 to 24 years, with a mean age of 10.5 years. Of the 292 implants with known and documented integrity status, there were 102 intact, 76 unruptured with signs of leakage, and 114 ruptured. The frequency of implant rupture significantly increased with implant age. The average age of rupture was 13.4 years. The average age of signs of leakage was 10.1 years. There were no significant differences in failure rates among the implant types of four manufacturers. Analysis of both mammography and magnetic resonance imaging (MRI) as diagnostic modalities for differentiating intact implants, implant leakage, and implant rupture was performed. Standard mammography was less reliable in diagnosing implant leakage or rupture (sensitivity, 55 percent; specificity, 69 percent) than MRI (sensitivity, 72 percent; specificity, 82 percent). In conclusion, implant rupture occurred at a significantly increasing rate with implant age (10 to 15 years). These findings were independent of implant type or manufacturer. Mammography alone is a below- average diagnostic tool for detecting leakage or rupture, whereas MRI is a more accurate modality.