Rupture rate and patterns of shell failure with the McGhan Style 153 double-lumen breast implant.

摘要

BACKGROUND: In 2005, the McGhan Style 153 double-lumen breast implant was removed from the market secondary to a higher rupture rate when contrasted with other implants in the Core Study group. The high rupture rate was attributed to the development of a posterior tear in the shell where the inner implant is bonded to the posterior wall of the device. The purpose of this study was to report the existing rupture rate and describe the apparent mechanism of failure in the Style 153 double-lumen breast implant. METHODS: Ninety-seven patients (157 implants) who received the McGhan Style 153 double-lumen breast implant by the senior author were reviewed. Intraoperative observations and photographic images of ruptured implants were reviewed and characterized based on severity and location of implant rupture. RESULTS: With a mean length of follow-up of greater than 6 years (82 months), the rupture rate was 19.1 percent per implant. Physical examination (60 percent) was the most common method of rupture detection. Ruptures tended to occur in the marginal aspect (63 percent) of the implant. Only three ruptures occurred secondary to a disruption of the inner bladder from the posterior portion of the implant. CONCLUSIONS: The rupture rate of the Style 153 double-lumen breast implant is higher than previously thought, with a rate of 19.1 percent. A majority of ruptures occurred in the peripheral aspects of the implant. It is postulated that these ruptures were likely secondary to fold flaws that led to failure of the implant shell.