PIP IMPLANTÁTY – SOUČASNÉ ZNALOSTI A PŘEHLED LITERATURY

1. Parvizi N., Woods K. Regulation of medicines and medical devices: contrasts and similarities. Clinical Medicine 2014;14(1):6–12.

2. Woods K. Device regulation in the European Union: response from MHRA www.thelancet.com Vol 379 February 11, 2012, Published Online January 27, 2012, DOI:10.1016/S0140 - 6736(12)60121-4

3. The Safety of PIP Silicone Breast Implants. Sceintific Commitee on Emerging and Newly Identified Health Risks. Available at: ec.europa.eu/health/scientific_committees/policy/index_en.htm

4. FDA update on the safety of silicone gel-filled breast implants. June 2011. Available at: fda.gov/downloads/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/UCM260139.pdf

5. Zuckerman D., Booker N., Nagda S. Public health implications of differences in US and European Union regulatory policies for breast implants. Reproductive Health Matters 2012;20(40):102–11.

6. De Jong D., Vasmel WLE., de Boer JP., Verhave G., Barbe E., Casparie MK., vanLeeuwen FE. Anaplastic large-cell lymphoma in women with breast implants. JAMA 2008;300:2030–35.

7. Jewell M., Spear SL., Largent J., Oefelein MG., Adams WP Jr. Anaplastic large T-cell lymphoma and breast implants: a review of the literature. Plast Reconstr Surg. 2011;128:651–61.

8. The safety of Poly Implant Prothèse (PIP) Silicone Breast Implants. Update of the Opinion of February 2012. Available at: http://ec.europa.eu/health/scientific_committees/policy/index_en.htm DOI:10.2772/66097

9. Medical Device Alert (2010). Available at: http://www.mhra.gov.uk/home/groups/dts-bs/documents/medicaldevicealert/con076500.pdf.

10. NHS report, Bruce Keogh. Poly Implants Prostheses (PIP) Breast Implants: an Interim Report of the Expert Group. Available at: www.dh.gov.uk/publications.

11. Quality system regulation/saline pre-filled mammary implants (warning letters). Available at: www.fda.gov/downloads/ICECI/EnforcementActions/WarningLetters/2000/UCM068539.pdf?utm_campaign=Google2&utm_source=fdaSearch&utm_medium=website&utm_term=Jean-Claude%20Mas,%20a%20warning%20letter&utm_content=1

12. Scientific Committee on Emerging and Newly Identified Health Risks. Preliminary opinion on the safety of Poly Implant Prothése (PIP) silicone breast implants (2013 update). Sept 2013. Available at: http://ec.europa.eu/health/scientific_committees/emerging/docs/scenihr_o_038.pdf

13. Update of Recommendations for Women with Silicone filled Poly Implant Prosthesis (PIP) Breast Implants. Available at: http://ansm.sante.fr/var/ansm_site/storage/original/application/41d18730821fc09793fc9b848f6e090b.pdf

14. News Update on PIP Breast Implants. Available at: http://ansm.sante.fr/var/ansm_site/storage/original/application/6a13e8cbe0707afa7ce4e73b9e1ae47e.pdf

15. UK MHRA. MHRA statement on Earl Howe review. 14 May 2012. Available at: www.mhra.gov.uk/NewsCentre/Pressreleases/CON152654.

16. UK MHRA. PIP (Poly Implant Prothèse) breast implants-UK test results. 3 September 2010. Available at: www.mhra.gov.uk/NewsCentre/Pressreleases/CON093706.

17. United Kingdom Medicines and Healthcare Products Regulatory Agency. French authority test results for silicone gel filled breast implants manufactured by PIP (Poly Implant Prothèse). Available at: www.mhra.gov.uk/NewsCentre/Pressreleases/CON094170.

18. UK MHRA. Silicone gel filled breast implants manufactured by Poly Implant Prothèse (PIP). Medical Device Alert. October 2010. Reference No. MDA/2010/078.

19. Poly implant prothése (PIP) (2012) Breast implants: final report of the expert group. Available at: http://www.dh.gov.uk/health/2012/06/pip-report/.

20. BBC News. Dutch women advised to have breast implants removed. 11 January 2012. Available at: www.bbc.co.uk/news/world-europe-16515509.

21. UK MHRA. PIP breast implants – UK medical devices regulator says no evidence to support routine removal. 23 December 2011. Available at: www.mhra.gov.uk/NewsCentre/ Pressreleases/CON137935.

22. UK Department of Health. Department of Health statement on breast implants and response to expert group report. 6 January 2012. Available at: http://mediacentre.dh.gov. uk/2012/01/06/statement-on-breast-implants/.

23. Horton R. A serious regulatory failure, with urgent implications. Available at: www.thelancet.com Vol 379 January 14, 2012, DOI:10.1016/S0140-6736(12)60032-4

24. PIP breast implants – an updated Australian perspective. Available at: https://www.tga.gov.au/alert/pip-breast-implants-updated-australian-perspective

25. The PIP Breast Implant Scandal. Available at: http://www.ipras.org/news/pip-breast-implant-scandal

26. Fuel additive in banned PIP breast implants – report. BBC News Europe. 2 January 2012. Available at: http://www.bbc.co.uk/news/world-europe-16384708.

27. Daniels AU. Silicone Breast Implants Materials. Swiss Med Wkly. 2012;142:w13614 Published 23 July 2012, DOI:10.4414/smw.2012.13614

28. Cawrse NH., Pickford MA. Cutaneous manifestation of silicone dissemination froma PIP implant. A case for prophylactic explantation? J Plast Reconstr Aesthet Surg. 2011;64 (8):e208–9.

29. Tickunas T., Howarth S., Godwin Y. Inflammatory changes of the nipple areolar complex of a patient with PIP breast implants: A possible immune response to free silicone from gel bleed? J Plast Reconstr Aesthet Surg. 2014;67(3):423–5.

30. Correia-Sá I., Rodrigues-Pereira P., Marques M. The ‘‘PIP Problem’’: Clinical and Histologic Characteristics. Aesth Plast Surg 2013;37:936–940, DOI 10.1007/s00266-013-0196-z

31. Malata CM. A single surgeon’s experience of the PIP breast implant “saga”: Indications for surgery and treatment options. J Plast Reconstr Aesthet Surg. 2013;66: e141–5.

32. Zambacos GJ., Molnar C., Mandrekas AD. Silicone Lymphadenopathy After Breast Augmentation: Case Reports, Review of the Literature, and Current Thoughts. Aesth Plast Surg. 2013;37:278–89.

33. Carillon MA., Giard S., Emmanuelli V., Houpeau JL., Ceugnart L., Chauvet MP. Breast implants and health alert PIP: experience of the regional cancer center of Lille. Bull Cancer. 2012,1;99(2):147–53.

34. Berry MG., Stanek JJ. The PIP mammary prosthesis: A product recall study. J Plast Reconstr Aesthet Surg. 2012;65:697–704.

35. Chummun S., McLean NR. Poly Implant Prothe`se (PIP) breast implants: Our Experience. The Surgeon 2013;11:241–5.

36. Oulharj S., Pauchot J., Tropet Y. PIP breast implant removal: A study of 828 Cases. J Plast Reconstr Aesthet Surg. 2014;67:302–7.

37. 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.

38. Maijers MC., Niessen FB., Veldhuizen JFH., Ritt MJPF., Manoliu RA. Magnetic Resonance Imaging Screening Results Compared with Explantation Results in Poly Implant Prothése Silicone Breast Implants, Recalled from the European Market in 2010. Plast. Reconstr. Surg. 2014;133(2):114e–20e.

39. Berry MG., Stanek JJ. The PIP mammary prosthesis: a product recall study. J Plast Reconstr Aesthet Surg. 2012;65(6):697–704.

40. Berry MG., Stanek JJ. PIP implant biodurability: A post-publicity Update. J Plast Reconstr Aesthet Surg. 2013; 66:e1174–81.

41. Khan UD. Poly Implant Prothe`se (PIP) Incidence of Device Failure and Capsular Contracture: A Retrospective Comparative Analysis. Aesth Plast Surg. 2013;37:906–13.

42. Beretta G., Malacco M. Chemical and physicochemical properties of the high cohesive silicone gel from Poly Implant Prothése (PIP) breast prostheses after explantation: A preliminary, comparative analytical investigation. J Pharm Biomed Analysis 2013;78(79):75–82.

43. Yildirimer L., Seifalian AM., Butler PE. Surface and mechanical analysis of explanted Poly Implant Prosthe`se silicone breast implants. Brit J Surg. 2013;100:761–7.

44. Lienhart A., Auroy Y., Pequignot F., Benhamou D., Warszawski J., Bovet M., Jougla E. Survey of anesthesia-related mortality in France. Anesthesiology 2006;105(6):1087–97.

45. Fasting S. Risk in anaesthesia. Tidsskr Nor laegeforen 2010;130(5):498–502.

46. Torjesen I. Hundreds of thousands of pounds of NHS funds have been spent on care of private patients with PIP implants. BMJ 2012;344:e1259.

47. Lake E., Ahmad S., Dobrashian R. The sonographic appearances of breast implant rupture. Clin Radiol. 2013;68:851–8.

48. Helyar V., Burke C., McWilliams S. The ruptured PIP breast implant. Clin Radiol. 2013; 68:845–50.

49. Freshwater MF. LETTER FROM AMERICA. The PIP crisis: De´ja` vu all over again? J Plast Reconstr Aesthet Surg. 2012;65:840–3.

50. Howe E. Poly Implant Prothèse (PIP) silicone breast implants: Review of the actions of the MHRA and Department of Health. Internal review. London: Department of Health; May 2012. Reference No. 17528.

51. Dunmore C., Kelland K. Implant scandal sparks EU medical device rule revamp. 26 September 2012. Chicago Tribune. Available at: www.chicagotribune.com/health/sns-rt-us-eu-medical-devicesbre88p0oo-20120926,0,6914657.story.

52. Kierkegaard S., Kierkegaard P. Danger to public health: Medical devices, toxicity, virus and fraud. Comp Law Secur Rev. 2013;29:13–27.

53. 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.

54. Benkimoun P. Founder of PIP breast implant company gets four year prison sentence. BMJ 2013;347:f7528.