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Introduction: As the 4th Industrial Revolution era emerges, medical devices that apply technologies such as big data, artificial intelligence, and 3D printers are on the rise. In April 2019, Korea introduced the Act on Nurturing Medical Devices Industry and Supporting Innovative Medical Devices to shorten the market entry time by conducting step-by-step screening through the designation of innovative medical devices, priority screening systems, and special permission screening systems., Areas Covered: In this study, the Breakthrough Device Program of the United States, which has been implemented since 2016, and Korea's innovative medical device designation system were compared., Expert Opinion: Compared to the United States, Korea seems complicated because it has one more step in reviewing the innovative medical device group, but in terms of content, the two countries designate innovative medical devices on a similar basis. Neither country has established properly innovative medical device health insurance. Thus, a new insurance benefit scoring system based on actual evidence will have to be established. The role of experts in analyzing these data will be important and the voices of both innovative medical device manufacturers and medical field experts must be accepted.

This study aimed to assess the effectiveness and safety of BellaGel implants after implantation in Asian women and inform surgeons of another option for use in breast augmentation and reconstruction. This study was conducted in eight hospitals from November 27, 2015 to April 30, 2018. All patients underwent augmentation mammoplasty or implant-based breast reconstruction with BellaGel implants. Complication rates were compared between groups, and the cumulative hazard function was compared using the Kaplan-Meier survival analysis. Implants were grouped by surface type, and the cumulative hazard functions of total complication cases were compared. The biomechanical properties of the BellaGel implant and other company representative implants were tested using a mechanical testing machine, and surface topography was analyzed using a 3D laser scanning confocal microscope. There was a significant difference in the incidence of complications between the reconstruction (17.1%) and augmentation (4.7%) groups, but no significant difference in the complication rates of each group. There was no difference in the reoperation or revision rates between the groups. The log rank test showed a statistically significant difference in cumulative hazard function between the groups. Among the three types of implants (smooth, textured, and microtextured), the microtextured type had the lowest complication rate. The BellaGel microtexture implant had the highest maximal tensile load and displacement value. The BellaGel and Silksurface implants had the highest stored energy, although there was no significant difference. BellaGel implants can serve as a criterion for the selection of safe and effective implants among currently available implants., Competing Interests: Declaration of Competing Interest None declared., (Copyright © 2020 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.)

The demand for high-quality silicone breast implants is rising. This was the first clinical study on implantation of Asian company-made silicone breast implants into Asian women. The authors report 4-year study data for BellaGel implants. This study is an ongoing 10-year study with 103 subjects undergoing augmentation or primary reconstruction with BellaGel implants. To assess effectiveness, rupture and capsular contracture rates were measured and Kaplan-Meier analysis was performed. Paired t -test was used to determine significant changes in breast dimensions. Safety assessment included evaluation of all adverse reactions. Average follow-up period was 5.9 years. Implant rupture and capsular contracture rate through 4 years were 0 percent and 2.3 percent, respectively. Capsular contracture rate was lower in the augmentation group (0.8%) than in the reconstruction group (5.6%). Among the adverse events, procedural pain was the only complication considered device-related, apart from capsular contracture. These 4-year data from the ongoing implant study support the effectiveness and safety of BellaGel implants.

Background: Breast augmentation with fat transfer does not bear the risks associated with silicone implantation. The method can potentially be especially useful in Asian women, who often reject augmentation mammoplasty with implants. This prospective clinical trial evaluated the effects of external breast expansion on breast density and vessel count using magnetic resonance imaging., Methods: Thirty-four enrolled patients were instructed to apply one of two devices, the conventional BRAVA device (used in the AESTES trial) or a novel external expansion device (EVERA) designed for Asian women, continuously for 8 h per day for 12 weeks. For external expansion, the pressure was set to 25 mmHg. Follow-up examinations were performed for 4 weeks after completion of the expansion. The ratio between the fibroglandular and adipose tissues of the breast was measured using T1-weighted MRI, and the number of vessels in the breast tissue was determined before and after the treatment by contrast MRI. Additionally, the volume of the breast was measured by laser scanning before, during, and after the device application. The obtained measurements were compared within and between the groups at different time points., Results: Six patients dropped out, while 28 completed the trial without major side effects or adverse events. External expansion significantly increased breast vessel count in both the EVERA and AESTES groups (p = 0.019, p = 0.022). However, it did not significantly change breast density in either group (p = 0.186, p = 0.638). No significant intergroup differences were noted in vessel count (p = 0.874) or density (p = 0.482). Breast volume increases after 12 weeks of application were statistically significant in both groups, with mean changes of 81 ± 22 cc (AESTES) and 98 ± 30 cc (EVERA) (p < 0.001 in both cases)., Conclusions: External expansion resulted in a marked increase in breast vessel count but did not affect breast density. The observed increase in breast volume can be considered substantial for Asian women., Level of Evidence: Level II, therapeutic study., (Copyright © 2016 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.)