Position statement of IQUAM

• 1 Bondurant S, Ernster V, Herdman R. editors Safety of silicone breast implants, Report of the committee on the safety of silicone breast implants, Division of health promotion and disease prevention, Institute of medicine (hereinafter IOM). National Academy Press. Washington, D.C.: cited on 22.06.1999 Available from: www4.nationalacademies.org/news.nsf.
• 2 United Kingdom Report of the Independent Review Group (hereinafter IRG) "Silicone Gel Breast Implants. p25 Available from: www.silicone-review.gov.uk.
• 3 European Parliament Directorate General for Research, Scientific and Technological Options Assessment (hereinafter STOA) "Health Risks Posed by Silicone Implants in General with Special Attention to Breast Implants - Final Study". European Parliament Resolution on the petitions declared admissible concerning silicone implants (Petitions Nos 470/1998 and 771/1998) (2001/2068[INI]). p.22-23 Available from: www.europarl.eu.int
• 4 Health Council of the Netherlands (hereinafter Netherlands) “Gezondheidsrisico's van siliconen- borstimplantaten - Health Risks of Silicone Breast Implants” English Executive Summary. P. 11 Available from: www.gezondheidsraad.nl
• 5 IOM. p.204
• 6 IRG. p.24
• 7 STOA. p.25-6
• 8 Netherlands: p.34
• 9 Krischka K. etal. Arch Orth Traum Surg. 2004
• 10 Cunningham. Spine; 2003
• 11 Urban JBJS. 2000
• 12 Rizzo M, Pace TB. Premature failure of a hip hemiarthroplasty secondary to osteolysis and aseptic loosening. Am J Orthop 2003; 32: 206-9
• 13 Fornasier F. etal. J Biomed Mater Res B Appl Biomater. 2004
• 14 Available from: http://www.mhra.gov.uk/home/idcplg? Idc Service=SS_GET_PAGEandnode Id=738.
• 15 Arion H.. Carboxymethylcellulose hydrogel-filled breast implants. Our experience in 15 years. Ann Chir Plast Esthet 2002; 46: 55-9
• 16 Benediktsson K, Perbeck LG. Fluid retention in Bioplasty Misti Gold II breast prostheses with development of capsular contracture. Scand J Plast Reconstr Surg Hand Surg 2000; 34: 65-70
• 17 Ersek RA, Salisbury AV. Textured surface, nonsilicone gel breast implants: Four years' clinical outcome. Plast Reconstr Surg 1997; 100: 1729-39
• 18 Topaz M, Oppikofer C, Mokady S, Cogan U. Evidence of Extreme Oxidative State of Soybean Oil-filled (Trilucent^TM) Breast Implants - Safety Concerns. Abstract of presentation given at the International Symposium of the American Society for Aesthetic Plastic Surgery. Las Vegas: 2002
• 19 MDA HN. 2000 (05 Trilucent^TM Breast Implants: Recommendation to Remove. Manufacturer/supplier Lipomatrix Inc. / AEI Inc. . formerly Collagen Aesthetics International Inc.) [cited on 06/2000 Available from: http://www.medical-devices.gov.uk.
• 20 Assessment of Health Risks Associated with Exposure to Soybean Oil Filler Compounds and Peroxidation Products Potentially Released from Trilucent Breast Implants. Prepared for AEI Inc Gary WilliamsM. M.D Professor of Pathology Director Environmental Pathology and Toxicology. New York Medical College Valhalla; New York: 2000
• 21 Monstrey S, Delanghe J, Christophe A, Dhooge W, de WGreyt, Bernard D. etal. Biocompatibility and oxidative stability of radiolucent breast implants. Plast Reconstr Surg 2000; 105: 1429-34
• 22 Papanastasiou S, Odili J, Newman P, Evans J. Are triglyceride breast implants really biocompatible. Ann Plast Surg 2000; 45: 172-6
• 23 Gherardini G, Zaccheddu R, Basoccu G. Trilucent breast implants: Voluntary removal following the Medical Device Agency recommendation. Report on 115 consecutive patients. Plast Reconstr Surg 2004; 113: 102-7
• 24 Monstrey S, Christophe A, Delanghe J, Vriese SDe, Hamdi M, Landuyt KVan. etal. What exactly was wrong with the Trilucent breast implants. A unifying hypothesis. Plast Reconstr Surg 2004; 113: 847-56
• 25 Cicchetti S, Spina B, Nicolo G, Santi PL. Trilucent breast implants: Five years' experience from an Italian perspective. Ann Plast Surg 2003; 51: 229-35
• 26 Pritchard SA, Howe MC, Haboubi NY, Orton CI. Histological appearances of Trilucent breast implant capsules. Br J Plast Surg 2003; 56: 519-20
• 27 Hobman J, Liddington M. Inflammatory expansion of a breast augmented by a Trilucent implant. Br J Plast Surg 2002; 55: 694-5
• 28 Chatrath P, Oliver DW, Walker MS, Lamberty BG. Anti-soya antibodies and trilucent breast implants. Plast Reconstr Surg 2003; 111: 98-102
• 29 Kirkpatrick WN, Jones BM. The history of Trilucent implants and a chemical analysis of the triglyceride filler in 51 consecutively removed Trilucent breast prostheses. Br J Plast Surg 2002; 55: 479-89
• 30 Colville RJJ, McLean NR, Cross PA. True double capsules in oil-based (Trilucent) breast implants. Br J Plast Surg 2002; 55: 270-1
• 31 McGregor JC, Brown DT. Observations on a consecutive series of patients who have had Trilucent breast implants removed as recommended by the MDA Hazard Notice (May 2000). Br J Plast Surg 2002; 55: 231-4
• 32 Elson EM, Jones A, King R, Chapman P, Stanek J, Irvine AT. etal. Magnetic resonance imaging of Trilucent TM breast implants. Clin Radiol 2002; 57: 263-7
• 33 Rizkalla M, Webb J, Chuo CB, Matthews RN. Experience of explantation of Trilucent breast implants. Br J Plast Surg 2002; 55: 117-9
• 34 Munker R, Zorner C, McKiernan D, Opitz J. Prospective study of clinical findings and changes in 56 Trilucent implant explantations. Aesthetic Plast Surg 2001; 25: 421-6
• 35 McArthur PA, Green AR, Alcalay JR, Hancock K, Green AR. Histological examination of the capsules surrounding Trilucent breast implants. Br J Plast Surg 2001; 54: 684-6
• 36 McGregor JC. Further comment on Trilucent breast implants. Br J Plast Surg 2001; 54: 466-7
• 37 Ballesta AJ, Delgado DE, Miserachs B, Alcalay JN, Ros CV. Rupture of Trilucent-type breast implants: A clinical case. Aesthetic Plast Surg 2001; 25: 43-5
• 38 McGregor JC. Trilucent breast implants: A personal review of the current controversies (May 1999). Scott Med J 2000; 45: 177-9
• 39 Rizkalla M, Duncan C, Matthews RNN. Trilucent breast implants: A 3 year series. Br J Plast Surg 2001; 54: 125-7
• 40 Armstrong A, Alcalay JR, Jones BM. Patient satisfaction with Trilucent breast implants. Br J Plast Surg 2000; 53: 479-83
• 41 Choudhary S, Cadier MA, Cottrell BJ. Local tissue reactions to oil-based breast implant bleed. Br J Plast Surg 2000; 53: 317-8
• 42 Austin A.. Adverse incident reporting to the medical devices agency: A review of reports involving trilucent breast implants. Br J Plast Surg 2000; 53: 313-6
• 43 IOM. p.215
• 44 IRG. p.25
• 45 STOA. p.23
• 46 Netherlands: p.11
• 47 Available from: www.ibir.org.
• 48 Henriksen TF, Thuesen B. A nationwide registry for plastic surgery of the breast. Ugeskr Lζger. 2001 1631692
• 49 Henriksen TF, Olsen JH. The danish registry for plastic surgery of the breast. Status report. 2002
• 50 Henriksen TF, Olsen JH. The Danish Registry for Plastic Surgery of the Breast. Status report:. 2003
• 51 Henriksen TF, Hlmich LR, Friis S, McLaughlin JK, Fryzek J, Hyer AP. etal. The Danish Registry for Plastic Surgery of the Breast: Establishment of a nationwide registry for prospective follow-up, quality assessment and investigation of breast surgery. Plast Reconstr Surg 2003; 111: 2182-91
• 52 Henriksen TF, Hlmich LR, Fryzek JP, Friis S, McLaughlin JK, Hyer AP. etal. Incidence and severity of short-term complications after breast augmentation: Results from a nationwide breast implant registry. Ann Plast Surg 2003; 51: 531-9
• 53 Henriksen TF, Fryzek JP, Hlmich LR, McLaughlin JK, Kjyller K, Hyer AP. etal. Surgical intervention and capsular contracture after breast augmentation: A prospective study of risk factors. Ann Plast Surg 2005; 54: 343-51
• 54 Henriksen TF, Fryzek JP, Hlmich LR, McLaughlin JK, Krag C, Karlsen R. etal. Reconstructive breast implantation after mastectomy for breast cancer: Clinical outcomes in a nationwide, prospective cohort study. Arch Surg 2005; 140: 1152-9
• 55 Topaz M.. Long-Term Possible Hazardous Effects of Ultrasonically Assisted Lipoplasty. Letter to the Editor. Plast Reconstr Surg 1998; 102: 280
• 56 Topaz M, Gedanken A, Koltypin Y, Motiei M. Sonochemistry and Sonoluminescence in Simulated Ultrasound- assisted Lipoplasty Environment. Aesthetic Surg J 1999; 19: 205-13
• 57 Topaz M, Motiei M, Gedanken A, Meyerstein D, Meyerstein N. EPR Analysis of Radicals Generated by High-Intensity Ultrasound Energy in Ultrasound-Assisted Lipoplasty - Simulated Environment. Ultrasound Med Biol 2001; 27: 851-9
• 58 Ablon G, Rotunda AM. Treatment of lower eyelid fat pads using phosphatidylcholine: Clinical trial and review. Dermatol Surg 2004; 30: 422-8
• 59 Bates B.. 'Fat dissolving' substance injects CCs of controversy. Skin Allergy News 2003; 34: 1
• 60 Hexsel D, Serra M, Mazzuco R, Dal'Forno T, Zechmeister D. Phosphatidylcholine in the treatment of localized fat. J Drugs Dermatol 2003; 2: 511-8
• 61 Rittes PG. The use of phosphatidylcholine for correction of lower lid bulging due to prominent fat pads. Dermatol Surg 2001; 27: 391-2
• 62 Rittes PG. The use of phosphatidylcholine for correction of localized fat deposits. Aesthetic Plast Surg 2003; 27: 315-8
• 63 Rittes PG, Rittes JC, Amary MF. Injection of Phosphatidylcholine in Fat Tissue: Experimental Study of Local Action in Rabbits. Aesthetic Plast Surg 2006; 30: 474-8
• 64 Rotunda AMM, Kolodney MSS. Mesotherapy and phosphatidylcholine injections: Historical clarification and review. Dermatol Surg 2006; 32: 465-80
• 65 Young VL. Lipostabil: The effect of phosphatidylcholine on subcutaneous fat. Aesth Surg J 2003; 23: 413-7
• 66 Bergeret-Galley C, Latouche X, Illouz YG. The value of a new filler material in corrective and cosmetic surgery: Derma Live and Derma Deep. Aesthetic Plast Surg 2001; 25: 249-55
• 67 Achauer BM. A serious complication following medical-grade silicone injection of the face (Case report). Plast Reconstr Surg 1983; 71: 251-4
• 68 Amemiya T, Dake Y. Granuloma after augmentation of the eyelids with liquid silicone: An electron microscopic study. Ophthal Plast Reconstr Surg 1994; 10: 51-6
• 69 Mason J, Apisarnthanarax P. Migratory silicone granuloma. Arch Dermatol 1981; 117: 366-7
• 70 Milojevic B.. Complications after silicone injection therapy in aesthetic plastic surgery. Aesth Pls Surg 1982; 6: 203-6
• 71 Parmley VC, Barishak YR, Howes EL, Crawford JB. Foreign-body giant cell reaction to liquid silicone. Am J Ophthal 1986; 101: 680-3
• 72 Raszewski R, Guyuron B, Lash RH, McMahon JT, Tuthill RJ. A severe fibrotic reaction after cosmetic liquid silicone injection (Case report). J Craniomaxfac Surg 1990; 18: 225-8
• 73 Travis WD, Balogh K, Abraham JL. Silicone granulomas: Report of three cases and review of the literature. Hum Pathol 1985; 16: 19-27
• 74 Wassermann RJ, Greenwald DP. Debilitating silicone granuloma of the penis and scrotum. Ann Plast Surg 1995; 35: 505-10
• 75 Wilkie TF. Late development of granuloma after liquid silicone injections. Plast Reconstr Surg 1977; 60: 179-88
• 76 Zandi I.. Use of suction to treat soft tissue injected with liquid silicone. Plast Reconstr Surg 1985; 76: 307-9
• 77 Available from: http://www.fda.gov/bbs/topics/NEWS/NEW00267.html
• 78 Cheng NN, Wang YL, Wang JH, Zhang XM, Zhong H. Complications of breast augmentation with injected hydrophilic polyacrylamide gel. Aesthetic Plast Surg 2002; 26: 375-82
• 79 Christensen LH, Breiting VB, Aasted A, Jorgensen A, Kebuladze I. Long-term effects of polyacrylamide hydrogel on human breast tissue. Plast Reconstr Surg 2003; 111: 1883-90
• 80 Christensen L, Breiting V. Management of postoperative complications of breast augmentation by injected polyacrylamide hydrogel. Letter to the Editor. Aesthetic Plast Surg 2006; 30: 132
• 81 Evstatiev D.. Late complications after application of polyacrylamide hydrogel. Eur J Plast Surg 2006; 29: 127-32
• 82 Niedzielska I, Pajak J, Drugacz J. Late complications after polyacrylamide hydrogel injection into facial soft tissues. Letter to the Editor. Aesthetic Plast Surg 2006; 30: 377-8
• 83 Buelow Svon, Heimburg Dvon, Pallua N. Efficacy and safety of polyacrylamide hydrogel for facial and soft-tissue augmentation. Plast Reconstr Surg 2005; 116: 1137-46