Skip to main content

The Role of High Resolution Ultrasonography in Elucidating Features of the Breast Implants in Asymptomatic Patients After Implant-based Augmentation Mammaplasty

Abstract

Background

We conducted this study to describe the feasibility of high-resolution ultrasound (HRUS) in characterizing a breast implant in patients receiving an implant-based augmentation mammaplasty.

Methods

The current study was conducted in a total of 612 patients (n =6 12) receiving an implant-based augmentation mammaplasty at other hospitals between August 31, 2017 and August 31, 2020. Of these, 136 patients (n = 136; 272 breasts) receiving reoperation were included in the current study. We compared between the patients’ subjective awareness of a breast implant and its HRUS findings and an agreement between HRUS findings of a breast implant and its findings at reoperation.

Results

The proportion of the patients receiving a silicone gel-filled breast implant was increased from 65.44% (89/136) to 81.61% (111/136) on HRUS. Moreover, HRUS was effective in identifying a manufacturer of the device.

Conclusions

In conclusion, our results indicate that HRUS is feasible in characterizing a breast implant in patients receiving an implant-based augmentation mammaplasty. But further prospective, large-scale studies are warranted to corroborate our results.

Level of Evidence V

This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors. www.springer.com/00266.

This is a preview of subscription content, access via your institution.

Fig. 1.
Fig. 2.
Fig. 3.
Fig. 4.
Fig. 5.

References

  1. 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 

  2. Takayanagi S (2012) Augmentation mammaplasty using implants: a review. Arch Plast Surg 39(5):448–451

    Article  Google Scholar 

  3. 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 

  4. 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 

  5. 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 

  6. 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 

  7. Dorozhkin SV (2015) Calcium orthophosphate-containing biocomposites and hybrid biomaterials for biomedical applications. J Funct Biomater 7:6(3):708–832

    Article  Google Scholar 

  8. 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 

  9. 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 

  10. 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 

  11. 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 

  12. 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 

  13. 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 

  14. 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 

  15. Benito-Ruiz J, de Cabo F (2014) Ultrasonography: a useful tool for plastic surgeons. Aesthetic Plast Surg 38(3):561–571

    PubMed  Google Scholar 

  16. 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 

  17. Carovac A, Smajlovic F, Junuzovic D (2011) Application of ultrasound in medicine. Acta Inform Med 19(3):168–171

    Article  Google Scholar 

  18. 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 

  19. Wortsman X, Wortsman J (2011) Sonographic outcomes of cosmetic procedures. AJR Am J Roentgenol 197(5):W910–W918

    Article  Google Scholar 

  20. Wortsman X (2012) Common applications of dermatologic sonography. J Ultrasound Med 31(1):97–111

    Article  Google Scholar 

  21. 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 

  22. 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 

  23. 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 

  24. 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 

  25. 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 

  26. 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 

  27. 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 

  28. 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 

  29. 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.

  30. 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 

  31. 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 

  32. Black N (1996) Why we need observational studies to evaluate the effectiveness of health care. BMJ 312(7040):1215–1218

    CAS  Article  Google Scholar 

  33. 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 

  34. 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 

  35. 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 

  36. 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 

  37. 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 

Download references

Funding

Non-applicable.

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Jae Hong Kim.

Ethics declarations

Conflicts of interest

The authors have no conflicts of interest to disclose.

Ethical approval

The current study was conducted in compliance with the relevant ethics guidelines; all procedures performed in it were in accordance with the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards.

Informed consent

Written informed consent was waived due to the retrospective nature of the current study.

Additional information

Publisher's Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Rights and permissions

Reprints and Permissions

About this article

Verify currency and authenticity via CrossMark

Cite this article

Nam, S.E., Bang, B.S., Lee, E.K. et al. The Role of High Resolution Ultrasonography in Elucidating Features of the Breast Implants in Asymptomatic Patients After Implant-based Augmentation Mammaplasty. Aesth Plast Surg (2022). https://doi.org/10.1007/s00266-021-02701-w

Download citation

  • Received:

  • Accepted:

  • Published:

  • DOI: https://doi.org/10.1007/s00266-021-02701-w

Keywords

  • Breast implants
  • Ultrasonography
  • Lymphoma
  • Large-cell
  • Anaplastic
  • Fraud
  • Safety-based medical device withdrawals