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A Preliminary 1-year Follow-up Study to Assess Safety Outcomes of the Mentor® MemoryGel™ Xtra in Korean Women.
Plastic and Reconstructive Surgery 2023 March 4
BACKGROUND: To date, several attempts have been made to assess the safety of a silicone gel-filled breast implant in Korea. Still, however, there is a paucity of data suggesting the safety of the Mentor® MemoryGel™ Xtra (Mentor Worldwide LLC, Santa Barbara, CA) in a cohort of Korean patients. We therefore conducted this multi-center, retrospective study to assess 2-year safety outcomes of the Mentor® MemoryGel™ Xtra in Korean women.
METHODS: We evaluated a total of 4,052 patients (n=4,052) who received an implant-based augmentation mammaplasty using the Mento® MemoryGel™ Xtra at our hospitals between September 26, 2018 and October 26, 2020. We finally included a total of 1,740 Korean women (n=1,740; 3,480 breasts) in the current study. Through a retrospective review of the medical records, we analyzed incidences of postoperative complications and estimated time-to-events (TTEs). Then, we plotted the Kaplan-Meier survival and hazards as a curve.
RESULTS: A total of 220 cases (12.6%) of postoperative complications occurred; these include 120 cases (6.9%) of early seroma, 60 cases (3.4%) of rippling, 20 cases (1.1%) of early hematoma and 20 cases (1.1%) of capsular contracture. In addition, TTEs were estimated at 387.72±26.86 days (95% CI 335.08-440.36).
CONCLUSIONS: In conclusion, we describe preliminary 1-year safety outcomes of an implant-based augmentation mammaplasty using the Mentor® MemoryGel™ Xtra in a cohort of Korean patients. But further studies are warranted to corroborate our results.
METHODS: We evaluated a total of 4,052 patients (n=4,052) who received an implant-based augmentation mammaplasty using the Mento® MemoryGel™ Xtra at our hospitals between September 26, 2018 and October 26, 2020. We finally included a total of 1,740 Korean women (n=1,740; 3,480 breasts) in the current study. Through a retrospective review of the medical records, we analyzed incidences of postoperative complications and estimated time-to-events (TTEs). Then, we plotted the Kaplan-Meier survival and hazards as a curve.
RESULTS: A total of 220 cases (12.6%) of postoperative complications occurred; these include 120 cases (6.9%) of early seroma, 60 cases (3.4%) of rippling, 20 cases (1.1%) of early hematoma and 20 cases (1.1%) of capsular contracture. In addition, TTEs were estimated at 387.72±26.86 days (95% CI 335.08-440.36).
CONCLUSIONS: In conclusion, we describe preliminary 1-year safety outcomes of an implant-based augmentation mammaplasty using the Mentor® MemoryGel™ Xtra in a cohort of Korean patients. But further studies are warranted to corroborate our results.
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