Immunology of Silicones pp 39-48 | Cite as
Silicon and Silicone Levels in Patients with Silicone Implants
- 3 Citations
- 326 Downloads
Summary
Although a potential link between silicone gel breast implants and autoimmune connective tissue disease has been suggested, none has been proven. The potential role of silicone as an immune adjuvant remains very controversial. Currently available techniques do not easily allow precise measurements of silicone in tissues. However, all compounds containing silicon (which would include silicone) can be measured accurately. The present study was designed to measure silicon levels in the fibrous capsules of patients with silicone-gel breast implants, saline breast implants and silicone inflatable penile prostheses. Baseline control silicon levels were obtained from the breast tissue of patients undergoing breast reduction, who had no exposure to breast implants. All silicon measurements were carried out using atomic absorption spectrometry with a graphite furnace.
The mean silicon levels in 16 breast tissue control samples from 8 patients undergoing breast reduction varied from 0.046 to 0.742 μg/g dry weight, with the median mean being 0.0927. The median silicon level in capsules from 6 patients with saline implants was 7.7 μg/g (range 36.6). The median silicon level in capsules from 5 patients with silicone inflatable penile prostheses was 19.5 μg/g (range 34.8). Although the levels of silicon in capsules of patients with saline breast prostheses and penile implants were higher than in control samples, they were much lower than those from the capsules of the 58 gel implants (median 9979 μg/g).
Of the 58 silicone gel breast implants (from 20 patients with bilateral implant removal and 18 patients with unilateral removal) which had been inserted from 1974 to 1990, 28 were intact, 8 had pinhole leaks, and 22 were ruptured. Median capsule silicon levels and ranges for all 58 implants, for intact only, for leaking, and for ruptured were: 9979 (152,000), 10,477 (88,703), 6592 (65,396), and 9922 (152,387) μg/g respectively. There were no significant differences in silicon levels associated with implant status, duration in situ, or year of implantation. Capsule contracture was not associated with higher levels of capsule silicon. Capsule silicon levels were about 106 times higher than previously assayed blood silicon levels. This may be because silicone released from implants remains localized in cap-sular tissue, or because blood-borne silicone is quickly excreted. Using 29Si nuclear magnetic resonance spectroscopy, no detectable silicone was found in the blood of 7 control women and 7 women with silicone-gel implants (5 with known implant rupture).
Keywords
Magic Angle Spin Breast Implant Penile Prosthesis 29Si Nuclear Magnetic Resonance Silicon LevelPreview
Unable to display preview. Download preview PDF.
References
- 1.FDA Hearing: General and Plastic Surgery Devices Panel Meeting (1992) Transcript Vol I: 1–459, Vol II: 1-560, Vol III: 1-362.Google Scholar
- 2.Callahan T(1992) Tensile strength and liquid silicone bleed in FDA General Plastic Surgery Devices Panel Meeting. Transcript Vol I: 73–84.Google Scholar
- 3.Nairn JO, Lanzafame RJ, van Oss CJ (1993) The adjuvant effect of silicone-gel on antibody formation in rats. Immunol Invest 22:151–161.CrossRefGoogle Scholar
- 4.Barker DE, Retsky MI, Schultz S (1978) “Bleeding” of silicone from bag-gel breast implants and its clinical relation to fibrous capsule reaction. Plast Reconstr Surg 61:836–841.PubMedCrossRefGoogle Scholar
- 5.LeVier RR. (1992) Dow Corning presentation in FDA General Plastic Surgery Devices Panel Meeting Transcript Vol II: 31–49,142,219.Google Scholar
- 6.Baines CJ, Arseneau J, Smith DC. (1992) Summary of the report on silicone gel-filled breast implants Can Med Assoc J 147:1141–1146.Google Scholar
- 7.Peters WJ, Keystone E, Smith DC (1994) Factors affecting the rupture of silicone gel breast implants. Ann Plast Surg 32:449–451.PubMedCrossRefGoogle Scholar
- 8.Peters WJ (1994) The rupture of silicone gel breast implants. Ann Plast Surg 33:462–463.CrossRefGoogle Scholar
- 9.de Camara DL, Sheridan JM, Kammer BA (1993) Rupture and aging of silicone gel breast implants. Plast Reconstr Surg 91:829–834.Google Scholar
- 10.Gitelman HJ, Alderman FR (1990) Determination of silicon in biological samples using electrothermal atomic absorption spectrometry. J Anal At Spectrosc 5:587–589.CrossRefGoogle Scholar
- 11.Roberts NB, Williams P (1990) Silicon measurement in serum and urine by direct current plasma emission spectrometry. Clin Chem 36:1460–1465.PubMedGoogle Scholar
- 12.Marco-Franco JE, Torres VE, Nixon DE, Wilson DM, James EM, Bergstralh EJ, McCarthy JT (1991) Oxalate, silicon and vanadium in acquired cystic kidney disease. Clin Nephrol 35:52–58.PubMedGoogle Scholar
- 13.Peters WJ, Smith DC, Lugowski S, McHugh A (1995) Do patients with silicone gel breast implants have elevated levels of serum silicon compared to control patients? Ann Plast Surg 34:343–347.PubMedCrossRefGoogle Scholar
- 14.Evans GRD, Slezak S, Rieters M, Bercowy GM (1994) Silicon tissue assays in non-augmented cadaveric patients: is there a baseline level? Plast Reconstr Surg 93:1117–1122.PubMedCrossRefGoogle Scholar
- 15.Peters WJ, Smith D, Lugowski S, McHugh A, Keresteci A, Baines C (1995) An analysis of silicon levels in capsules of gel and saline breast implants and of penile prostheses. Ann Plast Surg, in press.Google Scholar
- 16.Dobbie JW, Smith MJB. Urinary and serum silicon in normal and uremic individuals. In: Evered D, O’Connor M (1986) Silicon Biochemistry: Ciba Foundation Symposium 121. New York: Wiley 194–213.Google Scholar
- 17.Carlisle EM (1986) Silicon as an essential trace element in animal nutrition. In: Silicon Biochemistry. Ciba Foundation Symposium 121. Evered D, O’Connor M (ed). New York: John Wiley and Sons 123–129.Google Scholar
- 18.Hosokawa S, Yoshida O (1990) Trace elements and complications in patients undergoing chronic hemodialysis. Nephron 55:375–379.PubMedCrossRefGoogle Scholar
- 19.Vargas A (1979) A shedding of silicone particles from inflated breast implants. Plast Reconstr Surg 64:252–253.PubMedCrossRefGoogle Scholar
- 20.Heggers JP, Kossovsksy N, Parsons RW (1983) Biocompatibility of silicone implants. Ann Plast Surg 11:38–41.PubMedCrossRefGoogle Scholar
- 21.Barrett DM, O’Sullivan D, Malizia AA (1991) Particle shedding and migration from silicone genito-urinary prosthetic devices. J Urolog 146:319–322.Google Scholar
- 22.Nairn JO, van Oss CJ, Lanzafame RJ (1993) The induction of autoantibodies to thyroglobulin in rats with silicone gel as adjuvant. Surg Forum 44:676–678.Google Scholar
- 23.Rose NR. Invited comment (1992) Ann Plast Surg 28:499–501.Google Scholar
- 24.LeVier RR, Harrison MC, Cook RR, Lane TH (1993) What is silicone? Plast Reconstr Surg 92:163–167.Google Scholar
- 25.Dobbie JW, Smith MJB (1982) The silicon content of body fluids. Scott Med J 27:17–19.PubMedGoogle Scholar
- 26.Marcovic BL, Abrambasic MD (1971) Experimental chronic interstitial nephritis compared with endemic human neuropathy. J Pathol 103:35–40.CrossRefGoogle Scholar
- 27.Belliveau JF, Griffiths WC, Wright GC, Tucci JR (1991) A direct current plasma emission spectrometric procedure for the assay of silicon in urine. Ann Clin Lab Sci 21:328–334.PubMedGoogle Scholar
- 28.Bellia JP, Birchall JD, Roberts NB (1994) Beer: a dietary source of silicon. Lancet 343:235.PubMedCrossRefGoogle Scholar
- 29.Garrido L, Pfleiderer B, Jenkins BG (1994) Migration and chemical modification of silicone in women with breast prostheses. Magn Reson Med 31:328–330.PubMedCrossRefGoogle Scholar