Archives of Plastic Surgery

Korean Society of Plastic and Reconstructive Surgeons (대한성형외과학회)
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The Clinical Implications of Poly Implant Proth$\grave{e}$se Breast Implants: An Overview

  • Wazir, Umar (The London Breast Institute, Princess Grace Hospital) ;
  • Kasem, Abdul (The London Breast Institute, Princess Grace Hospital) ;
  • Mokbel, Kefah (The London Breast Institute, Princess Grace Hospital)
  • Received : 2014.05.30
  • Accepted : 2014.07.12
  • Published : 2015.01.15
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Abstract

Mammary implants marketed by Poly Implant Proth$\grave{e}$se (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 Proth$\grave{e}$se", "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

References

  1. NHS Choices. PIP breast implants-latest from the NHS [Internet]. London: NHS Choices; 2012 [cited 2014 May 16]. Available from: http://www.nhs.uk/news/2012/01January/Pages/government-review-advises-on-french-pip-breast-implants.aspx.
  2. SCENIHR (Scientific Committee on Emerging and Newly Identified Health Risks). Scientific opinion on the Safety of Poly Implant Prothese (PIP) Silicone Breast Implants [Internet]. Brussels: European Union; 2013 [cited 2014 May 12]. Available from: http://ec.europa.eu/health/scientific_committees/emerging/docs/scenihr_o_043.pdf.
  3. Berry MG, Stanek JJ. PIP implant biodurability: a post-publicity update. J Plast Reconstr Aesthet Surg 2013;66:1174-81. https://doi.org/10.1016/j.bjps.2013.04.050
  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;129:1372-8. https://doi.org/10.1097/PRS.0b013e31824f0108
  5. Les protheses mammaires implantables PIP: etat des lieux [Internet]. Paris: ANSM; 2013 2012 [cited 2014 May 16]. Available from: http://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;138:801-6. https://doi.org/10.1001/archsurg.138.7.801
  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;33:430-6. https://doi.org/10.1007/s00266-009-9360-x
  8. Oulharj S, Pauchot J, Tropet Y. PIP breast implant removal: a study of 828 cases. J Plast Reconstr Aesthet Surg 2014;67:302-7. https://doi.org/10.1016/j.bjps.2013.12.016
  9. Tropet Y, Oulharj S, Pauchot J. PIP breast implants: a series of 217 explants. Bull Acad Natl Med 2013;197:123-30.
  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;66:1182-7. https://doi.org/10.1016/j.bjps.2013.05.003
  11. Hammond DC, Migliori MM, Caplin DA, et al. Mentor Contour Profile Gel implants: clinical outcomes at 6 years. Plast Reconstr Surg 2012;129:1381-91. https://doi.org/10.1097/PRS.0b013e31824ecbf0
  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;32:709-17. https://doi.org/10.1177/1090820X12452423
  13. Adams TS, Crook T, Cadier MA. A late complication following the insertion of hydrogel breast implants. J Plast Reconstr Aesthet Surg 2007;60:210-2. https://doi.org/10.1016/j.bjps.2006.01.012
  14. Berry RB. Rupture of PIP breast implants. J Plast Reconstr Aesthet Surg 2007;60:967-8.
  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); 2012 May. Reference No.: 17528.
  16. Maijers MC, Niessen FB. The clinical and diagnostic consequences of Poly Implant Prothese silicone breast implants, recalled from the European market in 2010. Plast Reconstr Surg 2013;131:394e-402e. https://doi.org/10.1097/PRS.0b013e31827c70aa
  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;57:558-66. https://doi.org/10.1016/j.anplas.2012.04.007
  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. https://doi.org/10.1016/j.anplas.2012.01.001
  19. Chummun S, McLean NR. Poly implant prothese (PIP) breast implants: our experience. Surgeon 2013;11:241-5. https://doi.org/10.1016/j.surge.2013.02.006
  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;133:1354-61. https://doi.org/10.1097/PRS.0000000000000021
  21. Swarts E, Kop AM, Nilasaroya A, et al. Rupture of poly implant prothese silicone breast implants: an implant retrieval study. Plast Reconstr Surg 2013;131:480e-489e. https://doi.org/10.1097/PRS.0b013e3182818a00
  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.
  23. Yildirimer L, Seifalian AM, Butler PE. Surface and mechanical analysis of explanted Poly Implant Prosthese silicone breast implants. Br J Surg 2013;100:761-7. https://doi.org/10.1002/bjs.9094
  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. https://doi.org/10.1016/j.jpba.2013.01.040
  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: http://www.mhra.gov.uk/home/groups/comms-ic/documents/websiteresources/con216972.pdf.
  26. Silikonbrostimplantat av market poly implant prothese (PIP): Lakemedelsverkets riskvardering och underlag till ny rekommendation [Internet]. Upsala, Sweden: Lakemedelsverket/Medical Products Agency; 2013 [cited 2014 May 16]. Available from: http://www.lakemedelsverket.se/upload/nyheter/2013/PIP/Riskvardering-av-PIP-implantat_2013-06-24.pdf.
  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;107:236-46. https://doi.org/10.1093/ajcp/107.2.236
  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.
  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.
  30. Brooke DN, Crookes MJ, Gray D, et al. Environmental risk assessment report: dodecamethylcyclohexasiloxane. Bristol, UK: Environment Agency (UK); 2009. Report No. SCHO 0309BPQY-E-P.
  31. Breast implants with silicone based gel filling from Poly Implant Prothese Company: update of tests results. Paris, France: Agence francaise de securite sanitaire des produits de sante (AFSSAPS); 2011.
  32. Update on TGA testing of PIP breast implants [Internet]. Symonston, AU: Therapeutic Goods Administration; 2011 [cited 2014 May 16]. Available from: http://www.tga.gov.au/safety/alerts-device-breast-implants-pip-130211-testing.htm.
  33. Report of lymphoma associated with breast implants [Internet]. Symonston C, Australia: Therapeutic Goods Administration; 2011 [cited 2014 May 16]. Available from: http://www.tga.gov.au/safety/alerts-device-breast-implants-110127.htm.
  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;23:202-15. https://doi.org/10.1016/j.reprotox.2006.11.011
  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: http://echa.europa.eu/documents/10162/13628/octamethyl_pbtsheet_en.pdf.
  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;106:173-7. https://doi.org/10.1177/0141076813480994
  37. Scientific opinion on the Safety of Poly Implant Prothese (PIP) Silicone Breast Implants (2013 update). Luxembourg: Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR); 2014. Report No. 43.
  38. Keogh B. Poly Implant Prothese (PIP) breast implants: final report of the Working Group. Leeds, UK: Department of Health, NHS Medical Directorate; 2012. Report No. 17744.
  39. Preliminary Opinion on the safety of Poly Implant Prothese (PIP) Silicone Breast Implants. Luxembourg: Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR); 2013.
  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;66:313-22. https://doi.org/10.1016/j.bjps.2012.09.033
  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;24:1167-75. https://doi.org/10.1007/s00330-014-3119-8
  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;37:278-89. https://doi.org/10.1007/s00266-012-0025-9
  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;375:356-62. https://doi.org/10.1007/s00216-002-1694-z
  44. Parvizi N, Woods K. Regulation of medicines and medical devices: contrasts and similarities. Clin Med 2014;14:6-12. https://doi.org/10.7861/clinmedicine.14-1-6

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