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Retrospective multicenter cohort analysis of 621 cases of BellaGel silicone breast implants with study of physicochemical properties and surface topography

Published:September 20, 2020DOI:https://doi.org/10.1016/j.bjps.2020.08.134

      Summary

      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.

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      References

        • Frey J.D.
        • Salibian A.A.
        • Karp N.S.
        • Choi M
        Implant-based breast reconstruction: hot topics, controversies, and new directions.
        Plast Reconstr Surg. 2019; 143: 404e-406e
      1. American Society of Plastic Surgeons. 2018 cosmetic plastic surgery statistics. https://www.plasticsurgery.org/documents/News/Statistics/2018/cosmetic-procedure-trends-2018.pdf.

        • Calobrace M.B.
        • Stevens W.G.
        • Capizzi P.J.
        • Cohen R.
        • Godinez T.
        • Beckstrand M
        Risk factor analysis for capsular contracture: a 10-year sientra study using round, smooth, and textured implants for breast augmentation.
        Plast Reconstr Surg. 2018; 141: 20S-28S
        • Brown T.
        Breast implant-associated anaplastic large cell lymphoma in Australia and New Zealand: high-surface-area textured implants are associated with increased risk.
        Plast Reconstr Surg. 2018; 141: 176e-177e
        • Reply D.AK.
        Breast implant-associated anaplastic large cell lymphoma in Australia and New Zealand: high-surface-area textured implants are associated with increased risk.
        Plast Reconstr Surg. 2018; 141: 177e-178e
        • Han J.
        • Jeong J.H.
        • Bang S.I.
        • Heo C.Y
        BellaGel breast implant: 4-year results of a prospective cohort study.
        J Plast Surg Hand Surg. 2019; 53: 232-239
        • Hammond D.C.
        • Canady J.W.
        • Love T.R.
        • Wixtrom R.N.
        • Caplin D.A
        Mentor contour profile gel implants: clinical outcomes at 10 years.
        Plast Reconstr Surg. 2017; 140: 1142-1150
        • Hammond D.C.
        • Migliori M.M.
        • Caplin D.A.
        • Garcia M.E.
        • Phillips C.A
        Mentor contour profile gel implants: clinical outcomes at 6 years.
        Plast Reconstr Surg. 2012; 129: 1381-1391
        • Coroneos C.J.
        • Selber J.C.
        • Offodile A.C.
        • Butler C.E.
        • Clemens M.W
        US FDA Breast implant postapproval studies: long-term outcomes in 99,993 patients.
        Ann Surg. 2019; 269: 30-36
        • Glasberg S.B.
        • Mills D.C.
        • Jewell M.L.
        • Gabriel A
        Comment on "US FDA Breast Implant Postapproval Studies: long-term Outcomes in 99,993 Patients".
        Ann Surg. 2019; 270: e55-ee7
      2. U. S. Food and Drug Administration. Summary of safety and effectiveness data. https://www.accessdata.fda.gov/cdrh_docs/pdf7/p070004b.pdf

        • Cunningham B.
        The mentor core study on silicone memorygel breast implants.
        Plast Reconstr Surg. 2007; 120 (discussion 30S-2S): 19S-29S
      3. U. S. Food and Drug Administration. Summary of safety and effectiveness data. https://www.accessdata.fda.gov/cdrh_docs/pdf2/P020056b.pdf

        • Sforza M.
        • Zaccheddu R.
        • Alleruzzo A.
        • et al.
        Preliminary 3-year evaluation of experience with SilkSurface and VelvetSurface Motiva silicone breast implants: a single-center experience with 5813 consecutive breast augmentation cases.
        Aesthet Surg J. 2018; 38: S62-S73
        • Valencia-Lazcano A.A.
        • Alonso-Rasgado T.
        • Bayat A
        Characterisation of breast implant surfaces and correlation with fibroblast adhesion.
        J Mech Behav Biomed Mater. 2013; 21: 133-148
        • Barr S.
        • Hill E.W.
        • Bayat A
        Functional biocompatibility testing of silicone breast implants and a novel classification system based on surface roughness.
        J Mech Behav Biomed Mater. 2017; 75: 75-81
        • Grinnell F.
        • Feld M.K.
        Fibronectin adsorption on hydrophilic and hydrophobic surfaces detected by antibody binding and analyzed during cell adhesion in serum-containing medium.
        J Biol Chem. 1982; 257: 4888-4893
        • Wei J.
        • Igarashi T.
        • Okumori N.
        • et al.
        Influence of surface wettability on competitive protein adsorption and initial attachment of osteoblasts.
        Biomed Mater. 2009; 4045002
        • Collier T.O.
        • Anderson J.M.
        • Brodbeck W.G.
        • Barber T.
        • Healy K.E
        Inhibition of macrophage development and foreign body giant cell formation by hydrophilic interpenetrating polymer network.
        J Biomed Mater Res A. 2004; 69: 644-650
        • Hotchkiss K.M.
        • Clark N.M.
        • Olivares-Navarrete R
        Macrophage response to hydrophilic biomaterials regulates MSC recruitment and T-helper cell populations.
        Biomaterials. 2018; 182: 202-215
        • Cheng M.H.
        • Huang J.J.
        Augmentation mammaplasty in Asian women.
        Semin Plast Surg. 2009; 23: 48-54
        • Park I.Y.
        • Kim M.R.
        • Jo H.H.
        • Lee M.K.
        • Kim M.J
        Association of the nipple-areola complexes with age, parity, and breastfeeding in Korean premenopausal women.
        J Hum Lact. 2014; 30: 474-479
        • Sung J.Y.
        • Jeong J.P.
        • Moon D.S.
        • et al.
        Short-term safety of augmentation mammaplasty using the BellaGel implants in Korean women.
        Plast Reconstr Surg Glob Open. 2019; 7: e2566