Crerand CE, Magee L (2013) Cosmetic and reconstructive breast surgery in adolescents: psychological, ethical, and legal considerations. Semin Plast Surg 27(1):72–78
Article
Google Scholar
Takayanagi S (2012) Augmentation mammaplasty using implants: a review. Arch Plast Surg 39(5):448–451
Article
Google Scholar
Blount AL, Martin MD, Lineberry KD, Kettaneh N, Alfonso DR (2013) Capsular contracture rate in a low-risk population after primary augmentation mammaplasty. Aesthet Surg J 33(4):516–521
Article
Google Scholar
Zingaretti N, Galvano F, Vittorini P, De Francesco F, Almesberger D, Riccio M, Vaienti L, Parodi PC (2019) Smooth prosthesis: our experience and current state of art in the use of smooth sub-muscular silicone gel breast implants. Aesthetic Plast Surg 43(6):1454–1466
Article
Google Scholar
Alster TS, West TB (2000) Human-derived and new synthetic injectable materials for soft-tissue augmentation: current status and role in cosmetic surgery. Plast Reconstr Surg 105(7):2515–2525 (discussion 2526–2528)
CAS
Article
Google Scholar
Colazo JM, Evans BC, Farinas AF, Al-Kassis S, Duvall CL, Thayer WP (2019) Applied bioengineering in tissue reconstruction, replacement, and regeneration. Tissue Eng Part B Rev 25(4):259–290
Article
Google Scholar
Dorozhkin SV (2015) Calcium orthophosphate-containing biocomposites and hybrid biomaterials for biomedical applications. J Funct Biomater 7:6(3):708–832
Article
Google Scholar
Schafer ME (2021) Fundamentals of high-resolution ultrasound in breast implant screening for plastic surgeons. Clin Plast Surg 48(1):59–69
Article
Google Scholar
Gorczyca DP, Gorczyca SM, Gorczyca KL (2007) The diagnosis of silicone breast implant rupture. Plast Reconstr Surg 120(7 Suppl 1):49S-61S
CAS
Article
Google Scholar
Sung JY, Jeong JP, Moon DS, Kim MS, Kim HC, Choi WS, Song KY, Kim HJ, Lim HG, Kim JH (2019) Short-term safety of augmentation mammaplasty using the BellaGel implants in Korean Women. Plast Reconstr Surg Glob Open 7(12):e2566
Article
Google Scholar
Choi MS, Chang JH, Seul CH (2020) A multi-center, retrospective, preliminary observational study to assess the safety of BellaGel® after augmentation mammaplasty. Eur J Plast Surg 43:577–582
Article
Google Scholar
Kim JH, Paik NS, Nam SY, Cho Y, Park HK (2020) The emerging crisis of stakeholders in implant-based augmentation mammaplasty in Korea. J Korean Med Sci 35(15):e103
Article
Google Scholar
Safran T, Gorsky K, Viezel-Mathieu A, Kanevsky J, Gilardino MS (2018) The role of ultrasound technology in plastic surgery. J Plast Reconstr Aesthet Surg 71(3):416–424
Article
Google Scholar
Chung KC, Wilkins EG, Beil RJ Jr, Helvie MA, Ikeda DM, Oneal RM, Forrest ME, Smith DJ Jr (1996) Diagnosis of silicone gel breast implant rupture by ultrasonography. Plast Reconstr Surg 97(1):104–109
CAS
Article
Google Scholar
Benito-Ruiz J, de Cabo F (2014) Ultrasonography: a useful tool for plastic surgeons. Aesthetic Plast Surg 38(3):561–571
PubMed
Google Scholar
Lucas VS, Burk RS, Creehan S, Grap MJ (2014) Utility of high-frequency ultrasound: moving beyond the surface to detect changes in skin integrity. Plast Surg Nurs 34(1):34–38
Article
Google Scholar
Carovac A, Smajlovic F, Junuzovic D (2011) Application of ultrasound in medicine. Acta Inform Med 19(3):168–171
Article
Google Scholar
Young SR, Bolton PA, Downie J (2008) Use of high-frequency ultrasound in the assessment of injectable dermal fillers. Skin Res Technol 14(3):320–323
CAS
Article
Google Scholar
Wortsman X, Wortsman J (2011) Sonographic outcomes of cosmetic procedures. AJR Am J Roentgenol 197(5):W910–W918
Article
Google Scholar
Wortsman X (2012) Common applications of dermatologic sonography. J Ultrasound Med 31(1):97–111
Article
Google Scholar
Grippaudo FR, Mattei M (2011) The utility of high-frequency ultrasound in dermal filler evaluation. Ann Plast Surg 67(5):469–473
CAS
Article
Google Scholar
Giovagnorio F, Drudi FM, Valentini C, Paonessa A (2004) Ultrasonography in follow-up of soft tissue augmentation of the face with synthetic materials: a pilot study. Acta Radiol 45(7):746–750
CAS
Article
Google Scholar
Schelke LW, Van Den Elzen HJ, Erkamp PP, Neumann HA (2010) Use of ultrasound to provide overall information on facial fillers and surrounding tissue. Dermatol Surg 36(Suppl 3):1843–1851
CAS
Article
Google Scholar
Bengtson BP, Eaves FF 3rd (2012) High-resolution ultrasound in the detection of silicone gel breast implant shell failure: background, in vitro studies, and early clinical results. Aesthet Surg J 32(2):157–174
Article
Google Scholar
Rietjens M, Villa G, Toesca A, Rizzo S, Raimondi S, Rossetto F, Sangalli C, De Lorenzi F, Manconi A, Matthes AGZ, Chahuan B, Brenelli F, Bellomi M, Petit JY (2014) Appropriate use of magnetic resonance imaging and ultrasound to detect early silicone gel breast implant rupture in postmastectomy reconstruction. Plast Reconstr Surg 134(1):13e–20e
CAS
Article
Google Scholar
Munhoz AM, Chala L, Melo G, Azevedo Marques Neto A, Tucunduva T (2021) Clinical and MRI Evaluation of Silicone Gel Implants with RFID-M Traceability System: A Prospective Controlled Cohort Study Related to Safety and Image Quality in MRI Follow-Up. Aesthetic Plast Surg. https://doi.org/10.1007/s00266-021-02355-8
Article
PubMed
Google Scholar
Mendonça Munhoz A, Chala L, de Melo GG, Marques Filho AA, Tucunduva T, Gemperli R (2019) Usefulness of radio frequency identification device in diagnosing rotation of motiva SmoothSilk Implants after Augmentation Mammoplasty. Plast Reconstr Surg Glob Open 7(11):e2497
Article
Google Scholar
Kim JH (2021) The Manufacturer’s deliberate modification of the shell structure of the BellaGel® SmoothFine in violation of the regulatory requirement. J Surg Open Access 7(1):1–5
Google Scholar
Nam SE, Bang BS, Lee EK, Sung JY, Song KY, Yoo YB, Park DW, Kim JH (2021) Use of high-resolution ultrasound in characterizing a breast implant and detecting a rupture of the device before reoperation in women receiving augmentation mammaplasty. Plast Reconstr Surg In Press.
Song KY, Sung JY, Choi WS, Lim HG, Kim JH (2021) An ultrasound-assisted approach to an early detection of complications of an implant-based augmentation mammaplasty using the BellaGel® SmoothFine: preliminary 3-year clinical experience. J Surg Open Access 7(2):1–12
Google Scholar
Gibbons RD, Amatya AK, Brown CH, Hur K, Marcus SM, Bhaumik DK, Mann JJ (2010) Post-approval drug safety surveillance. Annu Rev Public Health 31:419–437
Article
Google Scholar
Black N (1996) Why we need observational studies to evaluate the effectiveness of health care. BMJ 312(7040):1215–1218
CAS
Article
Google Scholar
Rothwell PM (2005) External validity of randomised controlled trials: “to whom do the results of this trial apply?” Lancet 365(9453):82–93
Article
Google Scholar
Franklin JM, Liaw KL, Iyasu S, Critchlow CW, Dreyer NA (2021) Real-world evidence to support regulatory decision making: New or expanded medical product indications. Pharmacoepidemiol Drug Saf 30(6):685–693
Article
Google Scholar
Corrigan-Curay J, Sacks L, Woodcock J (2018) Real-world evidence and real-world data for evaluating drug safety and effectiveness. JAMA 320(9):867–868
Article
Google Scholar
Nelson MT, Brattain KA, Williams JM (2018) Does electronic identification enablement for silicone gel implants impact patient safety? J Surg Open Access 4(1):1–7
Google Scholar
Kim JH (2020) Association of the BellaGel® breast implant scandal with the poly implant Prothèse fraud: a review of literatures. J Surg Open Access 7(1):1–10
Google Scholar