Background: We conducted this study to assess preliminary 2-year safety outcomes of an implant-based augmentation mammaplasty using the BellaGel® SmoothFine in the context of the first Korean case of a medical device fraud.
Methods: Our clinical series of the patients (n = 579; 1,158 breasts) received augmentation using the BellaGel® SmoothFine, Naturgel™, Motiva Ergonomix™, Eurosilicone Round Collection™, Natrelle® INSPIRA™, Natrelle® 410, Mentor® MemoryGel Xtra or Microthane®. The patients were evaluated for incidences of postoperative complications and Kaplan-Meier survival and hazards.
Results: Overall, there were a total of 101 cases (17.4%) of postoperative complications; these include 31 cases (5.4%) of shape deformity, 21 cases (3.6%) of CC, 18 cases (3.1%) of early seroma, 8 cases (1.4%) of infection, 5 cases (0.9%) of early hematoma, 1 case (0.2%) of delayed hematoma, 1 case (0.2%) of rupture and 1 case (0.2%) of ripping. Moreover, there were also 15 cases (2.6%) of other complications. There were significant differences in incidences of postoperative complications between the breast implants from different manufacturers (P = 0.034). The Natrelle® 410 showed the longest survival (333.3±268.2 [141.5-525.1] days). A subgroup analysis showed that there were no significant differences in incidences of postoperative complications between the breast implants (P = 0.831). Moreover, the Natrelle® INSPIRA™ showed the longest survival (223.7±107.1 [-42.3-489.6] days).
Conclusions: Here, we describe preliminary 2-year safety outcomes of an implant-based augmentation mammaplasty using the BellaGel® SmoothFine in the context of the first Korean case of a medical device fraud.
Copyright: © 2023 Nam et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.