title: Rupture rate and patterns of shell failure with the McGhan Style 153 double-lumen breast implant.
abstract: 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.
authors.affiliation: Grand Rapids, Mich. From the Grand Rapids Medical Education and Research Center, Michigan State University General Surgery Residency and Plastic and Reconstructive Surgery Residency Programs; College of Human Medicine, Michigan State University; and Center for Breast and Body Contouring.
authors.forename: Keith C
authors.initials: KC
authors.lastname: Neaman
authors.forename: Mark
authors.initials: M
authors.lastname: Albert
authors.forename: Dennis C
authors.initials: DC
authors.lastname: Hammond
mesh_terms: D018427:Breast Implants; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008279:Magnetic Resonance Imaging; D008875:Middle Aged; D011475:Prosthesis Failure; D012421:Rupture