Clinical trial NCT00981266 - References

Augmentation — Spectra Breast Implant Study

Citation(s)

•   Berner I, Gaubitz M, Jackisch C, Pfleiderer B
  Comparative examination of complaints of patients with breast-cancer with and without silicone implants. Eur J Obstet Gynecol Reprod Biol. 2002 Apr 10;102(1):61-6.
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  , V.L. Ernster and R. Herdman, Eds. 2000. Safety of silicone breast implants. Committee on the Safety of Silicone Breast Implants, Division of Health Promotion and Disease Prevention, Institute of Medicine. Washington, D.C.: National Academy
•   Breiting VB, Hölmich LR, Brandt B, Fryzek JP, Wolthers MS, Kjøller K, McLaughlin JK, Wiik A, Friis S
  Long-term health status of Danish women with silicone breast implants. Plast Reconstr Surg. 2004 Jul;114(1):217-26; discussion 227-8.
•   Brinton LA, Buckley LM, Dvorkina O, Lubin JH, Colton T, Murray MC, Hoover R
  Risk of connective tissue disorders among breast implant patients. Am J Epidemiol. 2004 Oct 1;160(7):619-27.
•   Brinton LA, Lubin JH, Burich MC, Colton T, Brown SL, Hoover RN
  Breast cancer following augmentation mammoplasty (United States). Cancer Causes Control. 2000 Oct;11(9):819-27.
•   Brinton LA, Lubin JH, Burich MC, Colton T, Brown SL, Hoover RN
  Cancer risk at sites other than the breast following augmentation mammoplasty. Ann Epidemiol. 2001 May;11(4):248-56.
•   Brinton LA, Lubin JH, Burich MC, Colton T, Hoover RN
  Mortality among augmentation mammoplasty patients. Epidemiology. 2001 May;12(3):321-6.
•   Brown SL, Pennello G, Berg WA, Soo MS, Middleton MS
  Silicone gel breast implant rupture, extracapsular silicone, and health status in a population of women. J Rheumatol. 2001 May;28(5):996-1003.
•   Bryant H, Brasher P
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•   Chandra, G
  , et al. 1987. A convenient and novel route to bis(alkyne)platinum(0) and other platinum(0) complexes from Speier's hydrosilylation catalyst. Organometallics. 6:191-2
•   Cook LS, Daling JR, Voigt LF, deHart MP, Malone KE, Stanford JL, Weiss NS, Brinton LA, Gammon MD, Brogan D
  Characteristics of women with and without breast augmentation. JAMA. 1997 May 28;277(20):1612-7.
•   Deapen DM, Bernstein L, Brody GS
  Are breast implants anticarcinogenic? A 14-year follow-up of the Los Angeles Study. Plast Reconstr Surg. 1997 Apr;99(5):1346-53.
•   Flassbeck D, Pfleiderer B, Klemens P, Heumann KG, Eltze E, Hirner AV
  Determination of siloxanes, silicon, and platinum in tissues of women with silicone gel-filled implants. Anal Bioanal Chem. 2003 Feb;375(3):356-62. Epub 2003 Jan 28.
•   Fryzek JP, Signorello LB, Hakelius L, Feltelius N, Ringberg A, Blot WJ, McLaughlin JK, Nyren O
  Self-reported symptoms among women after cosmetic breast implant and breast reduction surgery. Plast Reconstr Surg. 2001 Jan;107(1):206-13.
•   Hemminki E, Hovi SL, Sevón T, Asko-Seljavaara S
  Births and perinatal health of infants among women who have had silicone breast implantation in Finland, 1967-2000. Acta Obstet Gynecol Scand. 2004 Dec;83(12):1135-40.
•   Herdman RC, Fahey TJ Jr
  Silicone breast implants and cancer. Cancer Invest. 2001;19(8):821-32. Review.
•   Hölmich LR, Kjøller K, Fryzek JP, Høier-Madsen M, Vejborg I, Conrad C, Sletting S, McLaughlin JK, Breiting V, Friis S
  Self-reported diseases and symptoms by rupture status among unselected Danish women with cosmetic silicone breast implants. Plast Reconstr Surg. 2003 Feb;111(2):723-32; discussion 733-4.
•   Hölmich LR, Kjøller K, Vejborg I, Conrad C, Sletting S, McLaughlin JK, Fryzek J, Breiting V, Jørgensen A, Olsen JH
  Prevalence of silicone breast implant rupture among Danish women. Plast Reconstr Surg. 2001 Sep 15;108(4):848-58; discussion 859-63.
•   Hölmich LR, Vejborg IM, Conrad C, Sletting S, Høier-Madsen M, Fryzek JP, McLaughlin JK, Kjøller K, Wiik A, Friis S
  Untreated silicone breast implant rupture. Plast Reconstr Surg. 2004 Jul;114(1):204-14; discussion 215-6.
•   Jacobsen PH, Hölmich LR, McLaughlin JK, Johansen C, Olsen JH, Kjøller K, Friis S
  Mortality and suicide among Danish women with cosmetic breast implants. Arch Intern Med. 2004 Dec 13-27;164(22):2450-5.
•   Jakubietz, M
  G., et al. 2004. Breast augmentation: Cancer concerns and mammography - A literature review. Plast. Reconstr. Surg. 113:117e 122e.
•   Janowsky EC, Kupper LL, Hulka BS
  Meta-analyses of the relation between silicone breast implants and the risk of connective-tissue diseases. N Engl J Med. 2000 Mar 16;342(11):781-90.
•   Katzin WE, Centeno JA, Feng LJ, Kiley M, Mullick FG
  Pathology of lymph nodes from patients with breast implants: a histologic and spectroscopic evaluation. Am J Surg Pathol. 2005 Apr;29(4):506-11.
•   Kjøller K, Friis S, Signorello LB, McLaughlin JK, Blot WJ, Lipworth L, Mellemkjaer L, Winther JF, Olsen JH
  Health outcomes in offspring of Danish mothers with cosmetic breast implants. Ann Plast Surg. 2002 Mar;48(3):238-45.
•   Kjøller K, Hölmich LR, Fryzek JP, Jacobsen PH, Friis S, McLaughlin JK, Lipworth L, Henriksen TF, Høier-Madsen M, Wiik A, Olsen JH
  Self-reported musculoskeletal symptoms among Danish women with cosmetic breast implants. Ann Plast Surg. 2004 Jan;52(1):1-7.
•   Kjøller K, Hölmich LR, Fryzek JP, Jacobsen PH, Friis S, McLaughlin JK, Lipworth L, Henriksen TF, Jørgensen S, Bittmann S, Olsen JH
  Characteristics of women with cosmetic breast implants compared with women with other types of cosmetic surgery and population-based controls in Denmark. Ann Plast Surg. 2003 Jan;50(1):6-12.
•   Koot VC, Peeters PH, Granath F, Grobbee DE, Nyren O
  Total and cause specific mortality among Swedish women with cosmetic breast implants: prospective study. BMJ. 2003 Mar 8;326(7388):527-8.
•   Lappert, M
  F. and Scott, F.P.A. 1995. The reaction pathway from Speier's to Karstedt's hydrosilylation catalyst. J. Organomet. Chem. 492(2):C11-C13
•   Lewis, L
  N., et al. 1995. Mechanism of formation of platinum(0) complexes containing silicon-vinyl ligands. Organometallics. 14:2202-13
•   Lipworth L, Tarone RE, McLaughlin JK
  Silicone breast implants and connective tissue disease: an updated review of the epidemiologic evidence. Ann Plast Surg. 2004 Jun;52(6):598-601. Review.
•   Lugowski SJ, Smith DC, Bonek H, Lugowski J, Peters W, Semple J
  Analysis of silicon in human tissues with special reference to silicone breast implants. J Trace Elem Med Biol. 2000 Apr;14(1):31-42.
•   McLaughlin JK, Lipworth L
  Brain cancer and cosmetic breast implants: a review of the epidemiologic evidence. Ann Plast Surg. 2004 Feb;52(2):115-7. Review.
•   Miglioretti DL, Rutter CM, Geller BM, Cutter G, Barlow WE, Rosenberg R, Weaver DL, Taplin SH, Ballard-Barbash R, Carney PA, Yankaskas BC, Kerlikowske K
  Effect of breast augmentation on the accuracy of mammography and cancer characteristics. JAMA. 2004 Jan 28;291(4):442-50.
•   Pukkala E, Boice JD Jr, Hovi SL, Hemminki E, Asko-Seljavaara S, Keskimäki I, McLaughlin JK, Pakkanen M, Teppo L
  Incidence of breast and other cancers among Finnish women with cosmetic breast implants, 1970-1999. J Long Term Eff Med Implants. 2002;12(4):271-9.
•   Signorello LB, Fryzek JP, Blot WJ, McLaughlin JK, Nyrén O
  Offspring health risk after cosmetic breast implantation in Sweden. Ann Plast Surg. 2001 Mar;46(3):279-86.
•   Stein, J
  , et al. 1999. In situ determination of the active catalyst in hydrosilylation reactions using highly reactive Pt(0) catalyst precursors. J. Am. Chem. Soc. 121(15):3693-3703
•   Tugwell P, Wells G, Peterson J, Welch V, Page J, Davison C, McGowan J, Ramroth D, Shea B
  Do silicone breast implants cause rheumatologic disorders? A systematic review for a court-appointed national science panel. Arthritis Rheum. 2001 Nov;44(11):2477-84. Review.
•   Williams HJ, Weisman MH, Berry CC
  Breast implants in patients with differentiated and undifferentiated connective tissue disease. Arthritis Rheum. 1997 Mar;40(3):437-40.
•   Wolfe F, Anderson J
  Silicone filled breast implants and the risk of fibromyalgia and rheumatoid arthritis. J Rheumatol. 1999 Sep;26(9):2025-8. Erratum in: J Rheumatol 2000 Mar;27(3):825.

Study of the Safety and Effectiveness of the Mentor Spectra/Becker 80 Adjustable Breast Implant in Subjects Who Are Undergoing Primary Augmentation or Augmentation Revision

Details for clinical trial NCT00981266