DISCUSSION
rupture, capsular contracture
COMPLICATIONS, COMPLICATION
This analysis of the MemoryGel Xtra cohort from the MemoryGel and MemoryShape Combined Cohort Clinical Study is the first published clinical data from a prospective study on this novel innovative addition to the Mentor MemoryGel implant portfolio. MemoryGel Xtra breast implants are designed to reduce the incidence of implant-related wrinkling/rippling and its influence on capsular contracture and shell failure through optimal shell-gel filling. They are yet another differentiated implant option in the plastic surgeon's arsenal, providing improved central implant projection when such an influence on shape is desired. In the authors’ experience, these design elements make MemoryGel Xtra of particular use in females with thin skin envelopes and/or limited soft tissue coverage but are similarly ideal for a wide variety of patients.MemoryGel Xtra devices show low complication rates based on 3-year follow-up on over 81% of 287 females who were implanted with the devices, including 151 primary augmentation participants. Cumulative estimated risks through 3 years are presented in While the study to date has reported complication rates by device type too low to allow meaningful comparisons between device types with different silicone gel fill levels, experience suggests that by increasing the degree to which implant shells are filled, one may reduce the incidence of clinically significant wrinkling/rippling.The clinical effectiveness of MemoryGel Xtra was demonstrated via BREAST-Q patient-reported outcome measures. Primary augmentation participants reported significantly higher satisfaction with breasts, psychosocial well-being, and sexual well-being 1 year after implantation. Although a reduction in physical well-being was noted in this cohort, this is possibly attributable to a lingering postoperative effect, because 88% of these cases were submuscular augmentations which are known to be “associated with a delay in recovery of physical functioning.”Limitations of this analysis include the nature of follow-up data collection. Although follow-up visits are to be scheduled per the site's standard of care, the only requirement for annual follow-up is that the study participants fill out online questionnaires. It is therefore possible that complications have occurred that were not reported or, inversely, that some complications were reported inaccurately. In the case of reoperations, however, the surgeon is involved in reporting. In addition, lengthier follow-up is needed to accurately assess long-term complications, such as rupture.