Purpose: Since the original introduction of saline and silicone gel breast implants for aesthetic and reconstructive breast surgery, numerous studies have been performed investigating the failure rates for these devices. In 2005, the McGhan Style 153 double-lumen breast implant was removed from the market secondary to 3-year follow-up data from the Core Study showing a rupture rate of 8.3% which contrasted sharply with a 0.9% rupture rate for other round implants in that study group.  The high rupture rate was attributed to a design flaw that lead 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 is to review a single surgeon's experience with the 153 double lumen implant with the goal being to report the existing rupture rate and describe the apparent mechanism of implant failure.

Methods:  Ninety-seven patients (157 implants) who received the McGhan Style 153 double-lumen breast implant by the senior author were reviewed.  Data was collected detailing patient demographics, reason for implantation, intra-operative technique, and post-operative complications.   Patients with known implant rupture were identified and analyzed for risk factors. Intra-operative observations and photographic images of ruptured implants were reviewed and characterized based on severity and location of implant rupture.

Results:  Primary breast reconstruction was the principle reason for implantation in 60.8% of patients follow by secondary reconstruction (32%), primary augmentation (3.1%) and secondary aesthetic surgery (3.1%).  A majority of patients underwent bilateral procedures (61.9%), with a mean length of follow-up of greater than six years (82 months). Complications per implant included: rupture (19.1%), grade III/IV capsular contracture (13.3%), seroma (6.3%), and hematoma (3.8%).  Physical exam (40%), MRI (28%) and operative exploration (28%) were there most common methods of rupture detection, with a mean of 70 months till detection. Ruptures tended to occur in the marginal aspect (63%) of the implant frequently in the upper pole (46%).  The shape of most implants (66%) was maintained or only partially affected.  Only one rupture occurred secondary to a disruption of the inner bladder from the posterior portion of the implant. Those patients who did not receive drains at the time of surgery or who underwent a capsulectomy following implantation were at a higher risk for rupture (p <.05).  Otherwise no other risk factors were identified.

Conclusions: In our experience the rupture rate of the McGhan Style 153 double-lumen breast implant is higher than previously published.  A majority of ruptures occurred in the peripheral aspects of the implant and were not secondary to inner implant related disruption of the posterior shell.  These ruptures were likely secondary to fold flaws that lead to failure of the implant shell. Based on these results, it is recommended that patients with implanted 153's undergo continued postoperative screening for rupture via yearly serial exam supplemented with pocket exploration or MRI evaluation whenever rupture is suspected.