Clinical experience with a fourth-generation textured silicone gel breast implant: a review of 1012 Mentor MemoryGel breast implants.

BACKGROUND: Since the introduction of fourth- and fifth-generation silicone gel implants, manufacturers have conducted several prospective, multicenter trials to examine their safety and efficacy. However, these studies were not standardized with regard to surgeon skill, pocket placement, operative technique, adjunct therapies, or postoperative management.

OBJECTIVE: The purpose of this study was to examine the surgical outcomes of a single surgeon (WGS) in a consecutive series of breast augmentation cases using a fourth-generation cohesive silicone MemoryGel breast implant (Mentor, Santa Barbara, CA).

METHODS: A retrospective chart review was conducted to identify all patients who underwent silicone breast augmentation within the Mentor Adjunct Silicone MemoryGel breast implant by a single surgeon (WGS) within a single free-standing outpatient surgical center over a 13-year period (1992 to 2006). For each patient, demographic information, comorbidities, and surgical information (implant size and concomitant surgery) were recorded. In addition, outcomes were analyzed to identify complications and the need for surgical revision.

RESULTS: A total of 1012 fourth-generation, textured, cohesive silicone gel implants were placed in 511 patients during the 13-year study period. The overall complication rate per implant was 5.5% (n=56 implants in 43 patients). The most common complication was capsular contracture (n=26; 2.6 %) followed by abnormal scarring (n=11; 1.1%). The overall revision rates per patient and per implant were 8.0% (n = 41 patients) and 6.8% (n = 69 implants), respectively. The average time interval between initial implantation and revision was 18.5 months (range, 2 weeks to 26 months). The most common indication for surgical revision was patient desire for implant size change (n=15 patients) followed by Baker class III or IV capsular contracture (n=13 patients). The presence of previous surgery for capsular contracture was not statistically correlated to the need for revision (P= .326). Age (P= .568), previous history of breast surgery (P= .704), and history of smoking (P= .138) were also not statistically correlated to revision. Placement of the implant in the subglandular position (n=30 implants), however, was statistically correlated with need for revision (P< .01).

CONCLUSIONS: Mentor fourth-generation cohesive silicone gel implants possess a complication and revision profile that is superior to earlier-generation silicone gel implants. Implantation with MemoryGel implants, when standardized with regard to surgeon and operative technique, can have significantly reduced complication and revision rates compared to the Mentor Core Data.