Skip to main content

Advertisement

SpringerLink
Log in

Mechanical Performance of Poly Implant Prosthesis (PIP) Breast Implants: A Comparative Study

  • Original Article
  • Breast Surgery
  • Published:
Aesthetic Plastic Surgery Aims and scope Submit manuscript

Abstract

Background

There is societal concern regarding potential health problems associated with breast implants. Much of this distrust climate was a reaction to the Poly Implant Prosthesis (PIP) scandal. Studying the mechanisms of implant rupture is an important step for their improvement. The mechanical behaviour of breast implant shells was studied on explanted and virgin implants. Implants from both PIP and another brand (brand X), currently in the market, were considered.

Methods

To study the mechanical behaviour of the shell, a total of 940 samples from 11 explants and 5 control implants were analysed. The experimental protocol follows the ISO standards for shell integrity and determination of tensile stress–strain properties. Pearson correlation analyses and the multi-factor ANOVA statistical tests were performed using mechanical test data.

Results

Both PIP control and explants had significant variations of stress (P = 0.0001) and shell thickness (P = 0.000) throughout the implant. The stress was directly related to shell thickness. Shell thickness varied significantly for PIP implants, exceeding the manufacturer’s specifications. Regarding the other brand, thickness variation was within manufacturer’s specifications.

Conclusions

The heterogeneous nature of PIP implants was confirmed. The implant shell thickness should be considered as a relevant parameter during the manufacturing process, for quality control purposes. These results may contribute to dispel mistrust and doubt surrounding breast implants, among the medical community and patients.

Level of Evidence III

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, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2
Fig. 3
Fig. 4
Fig. 5
Fig. 6
Fig. 7
Fig. 8
Fig. 9
Fig. 10
Fig. 11
Fig. 12
Fig. 13

Similar content being viewed by others

References

  1. Maijers MC, Niessen FB (2012) Prevalence of rupture in Poly Implant Prothèse silicone breast implants, recalled from the European market in 2010. Plast Reconstr Surg 129:1372–1378

    Article  CAS  PubMed  Google Scholar 

  2. Lockwood MD (1995) Strength, strain, energy, and toughness of silicone breast implant shells. In: Proceedings of the 1996 fifteenth southern, biomedical engineering conference, Dayton, OH March 29–31

  3. Phillips JW, de Camara DL, Lockwood MD, Grebner CC (1996) Strength of silicone breast implants. Plast Reconstr Surg 97:1215–1225

    Article  CAS  PubMed  Google Scholar 

  4. Greenwald DP, Randolph M, May JW (1996) Mechanical analysis of explanted silicone breast implants. Plast Reconstr Surg 98:269–272

    Article  CAS  PubMed  Google Scholar 

  5. Marotta JS, Amery DP, Widenhouse CW, Martin PJ, Goldberg EP (1998) Degradation of physical properties of silicone gel breast implants and high rates of implant failures. In: Proceedings of the 24th annual meeting of the society of biomaterials, 1 January, p 374

  6. Brandon HJ, Young VL, Jerina KL, Wolf CJ (1998) Variability in the properties of silicone gel breast implants. In: Proceedings of the 24th annual meeting of the society of biomaterials, 1 January, p 400

  7. Santos DC, Barroso ML, Gomes N, Ramião N, Martins P, Dia CC, Costa H (2015) PIP breast implant rupture—a retrospective study from Portugal. Eur J Plast Surg 38:301–308

    Article  Google Scholar 

  8. Brandon HJ, Jerina KL, Wolf CJ, Young VL (2012) Retrieval and analysis of breast implants emphasizing strength, durability, and failure mechanisms. In: Peter W, Brandon HJ, Jerina KL, Wolf W, Young VL (eds) Biomaterials in plastic surgery. Woodhead Publishing Limited, Cambridge, pp 154–217

    Chapter  Google Scholar 

  9. Scientific Committee on Emerging and Newly Identified Health Risks (2012) The safety of PIP silicone breast implants. http://ec.europa.eu/health/scientific_committees/emerging/docs/scenihr_o_043.pdf. Accessed 10 Mar 2012

  10. Wazir U, Kasem A, Mokbel K (2015) The clinical implications of Poly Implant Prothèse breast implants: an overview. Arch Plast Surg 42:4–10

    Article  PubMed  PubMed Central  Google Scholar 

  11. Swarts E, Kop A, Nilasaroya A, Keogh CV, Cooper T (2013) Rupture of Poly Implant Prothèse silicone breast implants: an implant retrieval study. Plast Reconstr Surg 131(4):480e–489e

    Article  CAS  PubMed  Google Scholar 

  12. Beretta G, Malacco M (2013) Chemical and physicochemical properties of the high cohesive silicone gel from poly implant prothese (PIP) breast prostheses after explantation: a preliminary, comparative analytical investigation. J Pharm Biomed Anal 78–79:75–82

    Article  PubMed  Google Scholar 

  13. Brandon HJ, Young VL, Jerina KL, Wolf CJ (1999) Effect of implantation surgery on the strength properties of silastic® II silicone gel breast implants. Aesthet Surg J 19:197–204

    Article  Google Scholar 

  14. Necchi S, Molina D, Turri S, Rossetto F, Rietjens M (2011) Failure of silicone gel breast implants: is the mechanical weakening due to shell swelling a significant cause of prostheses rupture? J Mech Behav Biomed Mater 4:2002–2008

    Article  CAS  PubMed  Google Scholar 

  15. Yildirimer L, Seifalian AM, Butler PE (2013) Surface and mechanical analysis of explanted Poly Implant Prothèse silicone breast implants. Br J Surg 100(6):761–767

    Article  CAS  PubMed  Google Scholar 

  16. Daniels AU (2012) Silicone breast implant materials. Swiss Med Wkly 142:w13614

    CAS  PubMed  Google Scholar 

  17. Mathieu DP, Jaime ME (2014) Manufacturing process: silicone breast implants. https://prezi.com/bgyd4zxce52m/manufacturing-process-silicone-breast-implants/?utm_campaign=share&utm_medium=copy. Accessed 9 Sept 2016

  18. Schubert DW, Kaschta J, Horch RE, Waltera BL (2013) On the failure of silicone breast implants: new insights by mapping the mechanical properties of implant shells. Soc Chem Ind 63:172–178

    Google Scholar 

  19. TGA (2013) PIP breast implants: update on TGA testing of PIP breast implants http://www.tga.gov.au/alert/pip-breast-implants-update-tga-testing-pip-breast-implants. Accessed 10 Mar 2013

  20. Pallant J (2005) SPSS survival manual: a step by step guide to data analysis using SPSS for Windows, 3rd edn. Ligare Book Printer, Sydney

    Google Scholar 

  21. Aktouf A, Auquit-Auckbur I, Coquerel-Beghin D, Delpierre V, Milliez PY (2012) Breast augmentation by Poly Implant Prothèses silicone implants: retrospective study about 99 patients. Rupture analysis and management. Ann Chir Plast Esthet 57(6):558–566

    Article  CAS  PubMed  Google Scholar 

  22. Carillon MA, Giard S, Emmanuelli V, Houpeau JL, Ceugnart L, Chauvet MP (2012) Breast implants and health alert PIP: experience of the regional cancer center of Lille. Bull Cancer 99(2):147–153

    PubMed  Google Scholar 

  23. Reyal F, Feron JG, Leman Detour S, Pourcelo AG, Valentin M, Phillippe AC et al (2013) The impact of Poly Implant Prothèse fraud on breast cancer patients: a report by the Institut Curie. Plast Reconstr Surg 131(4):690–695

    Article  CAS  PubMed  Google Scholar 

  24. Berry MG, Stanek JJ (2013) PIP implant biodurability: a post-publicity update. J Plast Reconstr Aesthet Surg 66:1174–1181

    Article  CAS  PubMed  Google Scholar 

  25. Quaba O, Quaba A (2013) PIP silicone breast implants: rupture rates based on the explantation of 676 implants in a single surgeon series. J Plast Reconstr Aesthet Surg 66(9):1182–1187

    Article  PubMed  Google Scholar 

  26. Oulharj S, Pauchot J, Tropet Y (2014) PIP breast implant removal: a study of 828 cases. J Plast Reconstr Aesthet Surg 67:302–307

    Article  CAS  PubMed  Google Scholar 

  27. Khan UD (2013) Poly Implant Prothèse (PIP) Incidence of device failure and capsular contracture: a retrospective study. Aesthet Plast Surg 37(5):906–913

    Article  Google Scholar 

  28. Spear SL, Murphy DK, Allergan Silicone Breast Implant U.S. Core Clinical Study Group (2014) Natrelle round silicone breast implants: core study results at 10 years. Plast Reconstr Surg 133:1354–1361

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  29. Berry RB (2007) Rupture of PIP breast implants. J Plast Reconstr Aesthet Surg 60:967e8

    Article  Google Scholar 

  30. Tan J, Chao YJ, Li X, Van Zee JW (2007) Degradation of silicone rubber under compression in a simulated PEM fuel cell environment. J Power Sources 172:782–789

    Article  CAS  Google Scholar 

  31. Bondurant S, Ernster V, Herdman R (1999) Safety of silicone breast implants. National Academies Press, Washington, p 560. ISBN: 0-309-51931-4

  32. Chief Medical Officer (CMO) (2012) Poly Implant Prothèse (PIP) breast implants. Report of Chief Medical officer. ISBN: 978-1-74241-733-2

  33. Agence nationale de sécurité du médicament et des produits de santé (ANSM). PIP breast implants. http://www.ansm.sante.fr/var/ansm_site/storage/original/application/ea94f5f3532f4f831d6a923ef553a77e.pdf. Accessed 16 June 2013

  34. Zheng L, Pereira PNR, Nakajima M, Sano H, Tagami J (2001) Relationship between adhesive thickness and microtensile bond strength. Op Dent 26:99–104

    Google Scholar 

Download references

Acknowledgements

The authors gratefully acknowledge funding from: Ministério da Ciência, Inovação e do Ensino Superior, FCT—Fundação para a Ciência e a Tecnologia, Portugal, under grants SFRH/BD/85090/2012, SFRH/BPD/111846/2015 and projects: LAETA—UID/EMS/50022/2013; UROSPHINX—Project 16842, cofinanced by Programa Operacional Competitividade e Internacionalização (COMPETE2020), through Fundo Europeu de Desenvolvimento Regional (FEDER) and by National Funds through FCT; NORTE-01-0145-FEDER-000022—SciTech—Science and Technology for Competitive and Sustainable Industries (NORTE2020).

Author information

Authors and Affiliations

  1. INEGI, LAETA, Faculty of Engineering, University of Porto, Campus da FEUP, Rua Dr. Roberto Frias 400, 4200-465, Porto, Portugal

    Nilza Alexandra Gomes Ramião, Pedro Alexandre Lopes de Sousa Martins, Francisco Bulhosa da Rocha Pereira & António Augusto Fernandes

  2. Department of Plastic Surgery, Gaia Hospital Center, Rua Conceição Fernandes, 4434-502, Vila Nova de Gaia, Portugal

    Maria da Luz Barroso & Diana Costa Santos

Authors
  1. Nilza Alexandra Gomes Ramião
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Pedro Alexandre Lopes de Sousa Martins
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Maria da Luz Barroso
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Diana Costa Santos
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Francisco Bulhosa da Rocha Pereira
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. António Augusto Fernandes
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Pedro Alexandre Lopes de Sousa Martins.

Ethics declarations

Conflict of interest

The authors have no commercial associations or financial disclosures that might pose or create a conflict of interest with information presented in this article. No funding was received for this work.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Ramião, N.A.G., Martins, P.A.L.S., Barroso, M.L. et al. Mechanical Performance of Poly Implant Prosthesis (PIP) Breast Implants: A Comparative Study. Aesth Plast Surg 41, 250–264 (2017). https://doi.org/10.1007/s00266-017-0776-4

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00266-017-0776-4

Keywords

Search

Navigation