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CC BY-NC 4.0 · Arch Plast Surg 2015; 42(01): 4-10
DOI: 10.5999/aps.2015.42.1.4
Review Article

The Clinical Implications of Poly Implant Prothèse Breast Implants: An Overview

Umar Wazir
The London Breast Institute, Princess Grace Hospital, London, UK
,
Abdul Kasem
The London Breast Institute, Princess Grace Hospital, London, UK
,
Kefah Mokbel
The London Breast Institute, Princess Grace Hospital, London, UK
› Author AffiliationsSupported by: Breast Cancer Hope Foundation
› Further Information
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Mammary implants marketed by Poly Implant Prothèse (PIP) were found to contain industrial grade silicone and this caused heightened anxiety and extensive publicity regarding their safety in humans. These implants were used in a large number of patients worldwide for augmentation or breast reconstruction. We reviewed articles identified by searches of Medline, PubMed, Embase, and Google Scholar databases up to May 2014 using the terms: "PIP", "Poly Implant Prothèse", "breast implants" and "augmentation mammoplasty" "siloxanes" or "silicone". In addition the websites of regulating bodies in Europe, USA, and Australia were searched for reports related to PIP mammary implants. PIP mammary implants are more likely to rupture than other implants and can cause adverse effects in the short to the medium term related to the symptoms of rupture such as pain, lumps in the breast and axilla and anxiety. Based on peer-reviewed published studies we have calculated an overall rupture rate of 14.5% (383/2,635) for PIP implants. However, there is no evidence that PIP implant rupture causes long-term adverse health effects in humans so far. Silicone lymphadenopathy represents a foreign body reaction and should be treated conservatively. The long-term adverse effects usually arise from inappropriate extensive surgery, such as axillary lymph node dissection or extensive resection of breast tissue due to silicone leakage.

Keywords

Prosthesis failure - Breast implants - Breast implantation - Silicone - Silicone gels

This study was funded by grants from the Breast Cancer Hope Foundation (London, UK).




Publication History

Received: 30 May 2014

Accepted: 12 July 2014

Article published online:
05 May 2022

© 2015. The Korean Society of Plastic and Reconstructive Surgeons. This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonCommercial License, permitting unrestricted noncommercial use, distribution, and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes. (https://creativecommons.org/licenses/by-nc/4.0/)

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  • References

  • 1 NHS Choices. PIP breast implants-latest from the NHS [Internet]. London: NHS Choices; 2012. cited 2014 May 16 Available from: https://www.nhs.uk/news/2012/01January/Pages/government-review-advises-on-french-pip-breast-implants.aspx
    Google Scholar
  • 2 SCENIHR (Scientific Committee on Emerging and Newly Identified Health Risks). Scientific opinion on the Safety of Poly Implant Prothèse (PIP) Silicone Breast Implants [Internet]. Brussels: European Union; 2013 cited 2014 May 12 Available from: https://ec.europa.eu/health/scientific_committees/emerging/docs/scenihr_o_043.pdf
    PubMedGoogle Scholar
  • 3 Berry MG, Stanek JJ. PIP implant biodurability: a post-publicity update. J Plast Reconstr Aesthet Surg 2013; 66: 1174-1181
    CrossrefPubMedGoogle Scholar
  • 4 Maijers MC, Niessen FB. Prevalence of rupture in poly implant Prothese silicone breast implants, recalled from the European market in 2010. Plast Reconstr Surg 2012; 129: 1372-1378
    CrossrefPubMedGoogle Scholar
  • 5 Les prothèses mammaires implantables PIP: état des lieux [Internet]. Paris: ANSM; 2013 2012 cited 2014 May 16. Available from: https://ansm.sante.fr/content/download/47687/615167/version/2/file/PIP_Etat-des-lieux_v2_Avril2013.pdf
  • 6 Holmich LR, Friis S, Fryzek JP. et al. Incidence of silicone breast implant rupture. Arch Surg 2003; 138: 801-806
    Google Scholar
  • 7 Heden P, Bronz G, Elberg JJ. et al. Long-term safety and effectiveness of style 410 highly cohesive silicone breast implants. Aesthetic Plast Surg 2009; 33: 430-436
    CrossrefPubMedGoogle Scholar
  • 8 Oulharj S, Pauchot J, Tropet Y. PIP breast implant removal: a study of 828 cases. J Plast Reconstr Aesthet Surg 2014; 67: 302-307
    CrossrefPubMedGoogle Scholar
  • 9 Tropet Y, Oulharj S, Pauchot J. PIP breast implants: a series of 217 explants. Bull Acad Natl Med 2013; 197: 123-130
    PubMedGoogle Scholar
  • 10 Quaba O, Quaba A. PIP silicone breast implants: rupture rates based on the explantation of 676 implants in a single surgeon series. J Plast Reconstr Aesthet Surg 2013; 66: 1182-1187
    CrossrefPubMedGoogle Scholar
  • 11 Hammond DC, Migliori MM, Caplin DA. et al. Mentor Contour Profile Gel implants: clinical outcomes at 6 years. Plast Reconstr Surg 2012; 129: 1381-1391
    CrossrefPubMedGoogle Scholar
  • 12 Maxwell GP, Van Natta BW, Murphy DK. et al. Natrelle style 410 form-stable silicone breast implants: core study results at 6 years. Aesthet Surg J 2012; 32: 709-717
    CrossrefPubMedGoogle Scholar
  • 13 Adams TS, Crook T, Cadier MA. A late complication following the insertion of hydrogel breast implants. J Plast Reconstr Aesthet Surg 2007; 60: 210-212
    CrossrefPubMedGoogle Scholar
  • 14 Berry RB. Rupture of PIP breast implants. J Plast Reconstr Aesthet Surg 2007; 60: 967-968
    PubMedGoogle Scholar
  • 15 Howe E. Poly Implant Prothese (PIP) silicone breast implants: review of the actions of the MHRA and Department of Health. Internal review. London: Department of Health (DoH); 05/2012. Reference No.: 17528
    Google Scholar
  • 16 Maijers MC, Niessen FB. The clinical and diagnostic consequences of Poly Implant Prothèse silicone breast implants, recalled from the European market in 2010. Plast Reconstr Surg 2013; 131: 394e-402e
    CrossrefPubMedGoogle Scholar
  • 17 Aktouf A, Auquit-Auckbur I, Coquerel-Beghin D. et al. Breast augmentation by Poly Implant Protheses silicone implants: retrospective study about 99 patients. Rupture analysis and management. Ann Chir Plast Esthet 2012; 57: 558-566
    CrossrefPubMedGoogle Scholar
  • 18 Crouzet C, Gangloff D, Chaput B. et al. Outcome at 18 months after the recall of Poly Implant Prosthesis. Experience of a cancer center. Ann Chir Plast Esthet 2012; 57: 9-15
    CrossrefPubMedGoogle Scholar
  • 19 Chummun S, McLean NR. Poly implant prothese (PIP) breast implants: our experience. Surgeon 2013; 11: 241-245
    CrossrefPubMedGoogle Scholar
  • 20 Spear SL, Murphy DK. Allergan Silicone Breast Implant U.S. Core Clinical Study Group. Natrelle round silicone breast implants: core study results at 10 years. Plast Reconstr Surg 2014. 133. 1354-1361
    Google Scholar
  • 21 Swarts E, Kop AM, Nilasaroya A. et al. Rupture of poly implant prothèse silicone breast implants: an implant retrieval study. Plast Reconstr Surg 2013; 131: 480e-489e
    CrossrefPubMedGoogle Scholar
  • 22 Barr S, Hill E, Bayat A. Current implant surface technology: an examination of their nanostructure and their influence on fibroblast alignment and biocompatibility. Eplasty 2009; 9: e22
    PubMedGoogle Scholar
  • 23 Yildirimer L, Seifalian AM, Butler PE. Surface and mechanical analysis of explanted Poly Implant Prosthese silicone breast implants. Br J Surg 2013; 100: 761-767
    CrossrefPubMedGoogle Scholar
  • 24 Beretta G, Malacco M. 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 2013; 78-79: 75-82
    CrossrefPubMedGoogle Scholar
  • 25 Composition and toxicity of PIP silicone: current MHRA view [Internet]. London, UK: Medicines and Healthcare products Regulatory Agency (MHRA); 2012. cited 2014 May 16 Available from: https://www.mhra.gov.uk/home/groups/comms-ic/documents/websiteresources/con216972.pdf
    Google Scholar
  • 26 Silikonbröstimplantat av märket poly implant prothèse (PIP): Läkemedelsverkets riskvärdering och underlag till ny rekommendation [Internet]. Upsala, Sweden: Läkemedelsverket/Medical Products Agency; 2013. cited 2014 May 16 Available from: https://www.lakemedelsverket.se/upload/nyheter/2013/PIP/Riskvardering-av-PIP-implantat_2013-06-24.pdf
    Google Scholar
  • 27 McConnell JP, Moyer TP, Nixon DE. et al. Determination of silicon in breast and capsular tissue from patients with breast implants performed by inductively coupled plasma emission spectroscopy. Comparison with tissue histology. Am J Clin Pathol 1997; 107: 236-246
    CrossrefPubMedGoogle Scholar
  • 28 Brooke DN, Crookes MJ, Gray D. et al. Environmental risk assessment report: octamethylcyclotetrasiloxane. Bristol, UK: Environment Agency (UK); 2009. Report No. SCHO0309 BPQZ-E-P
    Google Scholar
  • 29 Brooke DN, Crookes MJ, Gray D. et al. Environmental risk assessment report: decamethylcyclopentasiloxane. Bristol, UK: Environment Agency (UK); 2009. Report No. SCHO 0309BPQX-E-P
    Google Scholar
  • 30 Brooke DN, Crookes MJ, Gray D. et al. Environmental risk assessment report: decamethylcyclopentasiloxane. Bristol, UK: Environment Agency (UK); 2009. Report No. SCHO 0309BPQY-E-P
    Google Scholar
  • 31 Breast implants with silicone based gel filling from Poly Implant Prothèse Company: update of tests results. Paris, France: Agence française de sécurité sanitaire des produits de santé (AFSSAPS); 2011
    Google Scholar
  • 32 Update on TGA testing of PIP breast implants [Internet]. Symonston, AU: Therapeutic Goods Administration; 2011. cited 2014 May 16 Available from: https://www.tga.gov.au/safety/alerts-device-breast-implants-pip-130211-testing.htm
    Google Scholar
  • 33 Symonston C. Report of lymphoma associated with breast implants [Internet]. Australia: Therapeutic Goods Administration; 2011. cited 2014 May 16 Available from: https://www.tga.gov.au/safety/alerts-device-breast-implants-110127.htm
    Google Scholar
  • 34 Siddiqui WH, Stump DG, Plotzke KP. et al. A two-generation reproductive toxicity study of octamethylcyclotetrasiloxane (D4) in rats exposed by whole-body vapor inhalation. Reprod Toxicol 2007; 23: 202-215
    CrossrefPubMedGoogle Scholar
  • 35 Identification of PBT and vPvB substance: results of evaluation of PBT/vPvB properties: Octamethylcyclotetrasiloxane [Internet]. Helsinki, Finland: European Chemicals Agency (ECHA); 2012. cited 2014 May 16 Available from: https://echa.europa.eu/documents/10162/13628/octamethyl_pbtsheet_en.pdf
    Google Scholar
  • 36 Martindale V, Menache A. The PIP scandal: an analysis of the process of quality control that failed to safeguard women from the health risks. J R Soc Med 2013; 106: 173-177
    CrossrefPubMedGoogle Scholar
  • 37 Scientific opinion on the Safety of Poly Implant Prothèse (PIP) Silicone Breast Implants (2013 update). Report No. 43. Luxembourg: Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR); 2014
    Google Scholar
  • 38 Keogh B. Poly Implant Prothese (PIP) breast implants: final report of the Working Group. Report No. 17744. Leeds, UK: Department of Health, NHS Medical Directorate; 2012
    Google Scholar
  • 39 Preliminary Opinion on the safety of Poly Implant Prothèse (PIP) Silicone Breast Implants. Luxembourg: Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR); 2013
    Google Scholar
  • 40 Forster NA, Kunzi W, Giovanoli P. The reoperation cascade after breast augmentation with implants: what the patient needs to know. J Plast Reconstr Aesthet Surg 2013; 66: 313-322
    CrossrefPubMedGoogle Scholar
  • 41 Maijers MC, Niessen FB, Veldhuizen JF. et al. MRI screening for silicone breast implant rupture: accuracy, inter- and intraobserver variability using explantation results as reference standard. Eur Radiol 2014; 24: 1167-1175
    CrossrefPubMedGoogle Scholar
  • 42 Zambacos GJ, Molnar C, Mandrekas AD. Silicone lymphadenopathy after breast augmentation: case reports, review of the literature, and current thoughts. Aesthetic Plast Surg 2013; 37: 278-289
    CrossrefPubMedGoogle Scholar
  • 43 Flassbeck D, Pfleiderer B, Klemens P. et al. Determination of siloxanes, silicon, and platinum in tissues of women with silicone gel-filled implants. Anal Bioanal Chem 2003; 375: 356-362
    CrossrefPubMedGoogle Scholar
  • 44 Parvizi N, Woods K. Regulation of medicines and medical devices: contrasts and similarities. Clin Med 2014; 14: 6-12
    Google Scholar