Early Clinical Experience with Memorygel® Xtra Breast Implants in Augmentation and Reconstruction Patients

Goals/Purpose: MemoryGel® Xtra Breast Implants were developed to provide additional options for women desiring increased firmness, projection, and fullness. The ongoing 10-year MemoryGel® and MemoryShape® Combined Cohort Study was designed to collect additional post-approval clinical data on the long-term performance of MemoryGel® and MemoryShape® Breast Implants. Three-year follow-up data from the subset of patients within this study who were implanted with MemoryGel® Xtra Breast Implants were analyzed and are presented here to provide insight into early clinical experience using these devices.

Methods/Technique: Women undergoing augmentation (and at least 22 years of age) or reconstruction who were implanted with MemoryGel® Xtra Breast Implants were included in the current analysis. Here we describe operative characteristics and initial reoperation, explantation, and effectiveness data available as of December 2021. Effectiveness was assessed using the BREAST-Q to evaluate patient-reported quality of life and satisfaction with breast implants.

Results/Complications: Operative characteristics for the 282 patients (n=146 primary augmentation, n=76 revision augmentation, n=44 primary reconstruction, n=16 revision reconstruction) are shown in Table 1. Two year follow-up data were available for 231 patients and three year follow-up data were available for 214 patients. Details on reoperation and explantation are presented in Table 2. Importantly, for all augmentation patients assessed using BREAST-Q, there was improvement in satisfaction with breasts, psychosocial well-being, and sexual well-being (primary augmentation data are presented in Figure 1A). For reconstruction patients, improvements were noted in all modules, including physical well-being (primary reconstruction data are presented in Figure 1B).

Conclusion: These results provide initial clinical evidence demonstrating a low rate of early reoperations and explantations in addition to quality of life benefits including satisfaction with breasts, psychosocial well-being, and sexual well-being across all cohorts as well as improvements in physical well-being in reconstruction patients. Additional follow-up is ongoing to allow for the collection and reporting of longer-term (10 year) safety and effectiveness data.