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Rupture rate and patterns of shell failure with the McGhan Style 153 double-lumen breast implant
Keith C Neaman1, Mark Albert, Dennis C Hammond
1Grand 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.
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.
Insights
The McGhan Style 153 double-lumen breast implant has a high rupture rate of 19.1%. Most ruptures occurred peripherally, likely due to shell flaws, not posterior tears.
Area of Science:
- Plastic Surgery
- Biomaterials Science
- Medical Device Analysis
Background:
- The McGhan Style 153 double-lumen breast implant was recalled in 2005 due to a high rupture rate.
- The failure was linked to posterior shell tears at the bonding site of the inner and outer layers.
Purpose of the Study:
- To determine the current rupture rate of the recalled McGhan Style 153 double-lumen breast implant.
- To describe the failure mechanism of this specific breast implant model.
Main Methods:
- A retrospective review of 97 patients (157 implants) who received the Style 153 implant.
- Analysis of intraoperative findings and photographic evidence of ruptured implants.
Main Results:
- The overall rupture rate was 19.1% after a mean follow-up of 82 months.
- Ruptures were most commonly detected by physical examination (60%) and occurred at the implant periphery (63%).
- Posterior tears at the inner bladder bond accounted for only a small fraction of ruptures.
Conclusions:
- The Style 153 double-lumen breast implant exhibits a significant rupture rate of 19.1%.
- Peripheral ruptures are predominant, suggesting fold flaws in the implant shell as the likely cause of failure.
- The initially suspected posterior tear mechanism appears less common than peripheral shell failure.
