Differences in Capsular Contracture and Seroma Rates Between Two Types of Textured Silicone Gel Breast Implants: A Review of 1720 Implants in 866 Patients

Goals/Purpose:  Form-stable silicone gel breast implants represent the fifth generation of silicone gel augmentation devices. The combination of the additional silicone crosslinking combined with surface texturing may provide other advantages.  The purpose of the study is to compare the surgical outcomes of a consecutive series of breast augmentation cases using Siltex^ª round, textured, fourth-generation cohesive, MemoryGel silicone implant (Mentor, Santa Barbara, CA) to those in a consecutive series of patients by the same surgeon using Silimed fifth generation, round, textured, highly-cohesive, form stable, silicone gel implant (Sientra, Inc, Santa Barbara, CA). 

Methods/Technique: This is a single surgeon (WGS), single outpatient surgical center, retrospective review of a 13 year period of patients that underwent silicone breast augmentation with the Mentor Siltex^ªtextured silicone MemoryGel breast implants, as well as a 5 year period where Silimed textured, fifth generation, highly-cohesive, form-stable silicone gel breast implants. For each patient, demographic information, comorbidities, surgical information, complications, and need for revision were recorded.

Results/Complications: A total of 1720 implants in 866 patients were included. 1012 implants (in 511 patients) fourth generation, cohesive silicone breast implants and 708 (in 355 patients) textured, fifth generation, highly cohesive, form-stable silicone gel breast implants were identified.  The mean age was 32.2 years (19-72) for the MemoryGel group and 38 years (18-65) for the Silimed group. Average follow up was 32 months (8-47) for the MemoryGel group and 28 months (0.5-48) for the Silimed group.  There is a statistical difference in primary augmentations versus secondary augmentations noted in the two groups: half of the Silimed group underwent primary augmentations and a quarter of the Mentor group had primary augmentations.  Capsular contracture (Baker Grade II-IV) was noted in 26/1012 (2.6%) for the Memory Gel group and 5/708 (0.7%) implants in the Silimed group (statistically significant at p<0.05). For the MemoryGel and Silimed groups respectively, rupture was noted 4/1012 (0.4%) and 0/708, rippling 4/1012 (0.4%) and 2/708 (0.3%), ptosis 1/1012 (0.1%) and 2/708 (0.3%), infection 4/1012 (0.4%) and  5/708 (0.7%), seroma 0/1012 and 7/708 (1.0%, statistically significant at p<0.05), asymmetry 6/1012 (0.6%) and 5/708 (0.7%), galactorrhea  0/1012 and 2/708 (0.3%), scarring 11/1012 (1.1%) and 15/708 (2.1%), revisions 69/1012 (6.8%) and 28/708 (4.0%).

Conclusion: There is statistically significant decrease in capsular contracture noted in the textured, fifth generation, highly-cohesive, form stable, silicone gel breast implants as compared to the fourth generation, textured, cohesive, silicone breast implants used in this study. Although the frequency of secondary augmentations and reduction/reconstruction procedures is higher in the Mentor group, the raw percentages consistently show less capsular contracture in the Sientra group. In fact, the number of secondary mastopexies is higher in the Sientra group (44 vs. 20), but the consistently lower rate is still evident (0 vs. 10%). The statistically different seroma rate (0 vs. 1%) may be secondary to difference in texturing.  Prospective randomized controlled studies are needed to determine differences with the new textured, highly cohesive, form-stable, silicone breast implants.