A Preliminary Retrospective Study to Assess the Short-Term Safety of Traditional Smooth or Microtextured Silicone Gel-Filled Breast Implants in Korea

Sanghyuk Han; Robert Kim; Tae Seob Kim; Jung Heum Park; Seung Soo Kim; Cheol Jeong; Ji Heui Lee

doi:10.3390/medicina57121370

A Preliminary Retrospective Study to Assess the Short-Term Safety of Traditional Smooth or Microtextured Silicone Gel-Filled Breast Implants in Korea

Medicina (Kaunas). 2021 Dec 16;57(12):1370. doi: 10.3390/medicina57121370.

Authors

Sanghyuk Han¹, Robert Kim², Tae Seob Kim³, Jung Heum Park⁴, Seung Soo Kim⁵, Cheol Jeong⁶, Ji Heui Lee¹

Affiliations

¹ Department of Anesthesia and Pain Medicine, Korea Cancer Center Hospital, Seoul 01812, Korea.
² Department of Medical and Pharmaceutical Affairs, Doctor CONSULT, Seoul 06296, Korea.
³ The Door Plastic Surgery Clinic, Seoul 06134, Korea.
⁴ Mighty Plastic Surgery Clinic, Seoul 06612, Korea.
⁵ Liting Plastic Surgery Clinic, Seoul 06035, Korea.
⁶ Gangnam JC Plastic Surgery Clinic, Jinju 52703, Gyeongnam, Korea.

Abstract

Background and objectives: We conducted this preliminary retrospective study to assess the short-term safety of silicone gel-filled breast implants (SGBIs) that are commercially available in Korean women. Materials and methods :The current retrospective, observational study was conducted in a total of 2612 patients (n = 2612) who underwent augmentation mammaplasty using breast implants at our hospitals between 1 January 2017 and 31 August 2021. Results: Overall, there were a total of 248 cases (9.49%) of postoperative complications; these include 112 cases of early seroma, 52 cases of shape deformation, 32 cases of CC, 12 cases of early hematoma, 12 cases of rupture, 12 cases of infection, 12 cases of stretch deformities with skin excess and 4 cases of rippling. Overall complication-free survival of the breast implant was estimated at 1564.32 ± 75.52 days (95% CI 1416.39-1712.32). Then, the Motiva Ergonomix™ SilkSurface showed the longest survival (1528.00 ± 157.92 days [95% CI 1218.48-1837.56]), followed by the BellaGel^® SmoothFine (1458.4 ± 65.76 days [95% CI 1329.56-1587.28]), the Sebbin^® Sublimity (1322.00 ± 51.20 days [95% CI 1221.64-1422.32]), the BellaGel^® Smooth (1138.72 ± 161.28 days [95% CI 822.6-1454.84), the Mentor^® MemoryGel™ Xtra (698.4 ± 52.64 days [95% CI 595.28-801.52]) and the Natrelle^® INSPIRA™ (380.00 ± 170.88 days [95% CI 45.04-714.96]) in the decreasing order. On subgroup analysis, both the Motiva Ergonomix^TM and Mentor^® MemoryGel™ Xtra showed no postoperative complications. However, the BellaGel^® SmoothFine, Sebbin^® Sublimity and BellaGel^® Smooth showed incidences of 8.87%, 4.84% and 1.61%, respectively. A subgroup analysis also showed differences in incidences of postoperative complications between microtextured and smooth breast implants (15.18% vs. 16.67%). Conclusions: In conclusion, our results indicate that diverse types of an SGBI are commercially available and their safety profile varies according to the manufacturer. Plastic surgeons should consider the safety profile of each device in selecting the optimal types of the device for Korean women who are in need of an implant-based augmentation mammaplasty. However, this warrants a single-surgeon, single-center study with long periods of follow-up.

Keywords: Kaplan-Meier estimate; breast; breast implantation; esthetics; implant capsular contracture; postoperative complications.

Publication types

Observational Study

MeSH terms

Breast Implantation* / adverse effects
Breast Implants* / adverse effects
Female
Follow-Up Studies
Humans
Mammaplasty* / adverse effects
Postoperative Complications / epidemiology
Republic of Korea
Retrospective Studies
Silicone Gels / adverse effects

Substances

Silicone Gels