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Breast Implant Generations
Soy-filled implants (Trilucent) were marketed
for a short time period in Europe but were voluntarily
pulled from the market in 2000 by the manufacturer
(15,16). Trilucent implants contained Trilipid 6, a medicalgrade
triglyceride fat extracted from soybean oil. This material
was studied in animals and not shown to be a safety
concern. Approximately 5,000 European women and 50
U.S. women received the implants as part of European and
U.S. clinical trials. In the United States, the devices had
limited availability through an investigation device exemption
(IDE). The devices were taken out of clinical use due
to the development of inflammatory reactions resulting
from the leakage of the oil into the surrounding tissues
(17,18). The reactions resolved with removal of the devices
and did not present long-term health concerns. There are
presently no other alternative fillers available through clinical
trial.
Bibliography
1) Brody GS: On the safety of breast implants. Plas Reconstr Surg 100:1314, 1997.
2) Barker DE, Retsky MI, Schultz SL: The new low bleed mammary prosthesis: An experimental study in mice. Aesthetic Plast Surg 5:85, 1981.
3) Caffee HH: The influence of silicone bleed on capsular contracture. Ann Plast Surg 17: 284, 1986.
4) Institute of Medicine: Bondurant S, Ernster V, Herdman R (eds): Safety of silicone breast implants. Washington, DC, National Academy Press, 2000.
5) Young VL, Watson ME: Breast implant research: Where we have been, where we are, where we need to go. Clinics Plas Surg 28(3):451-483, 2001.
6) Cronin TD, Gerow FJ: Augmentation mammaplasty: A new "natural feel" prosthesis. Transactions of the Third International Congress of Plastic Surgery, Oct. 13-18, 1963, Amsterdam, The Netherlands, Excerpta Medica Foundation, 1963, pp 41-49.
7) Middleton MS McNamara MP Jr: Breast implant classification with MR imaging correlation. Radiographics 20:E1, 2000. http://ej.rsna.org/ej3/0112-99.f in/.
8) Peters W, Smith D, Lugowski S: Failure properties of 352 explanted silicone gel breast implants. Can J Plast Surg 4:55-58, 1996.
9) Rohrich RJ, Adams WP Jr, Beran SJ, et al: An analysis of silicone gel-filled breast implants: diagnosis and failure rates. Plas Reconstr Surg 102:2304, 1998.
10) Feng L-J, Amini SB: Analysis of risk factors associated with rupture of silicone gel breast implants. Plas Reconstr Surg 104:955, 1999.
11) Holmich LR, Kjoller K, Vejborg I, et al: Prevalence of silicone breast implant rupture among Danish women. Plas Reconstr Surg 108:848, 2001.
12) Baker DE, Retsky MI, Schults S: "Bleeding" of silicone from bag gel breast implants, and its clinical relation to fibrous capsule reaction. Plas Reconstr Surg 61: 836, 1978.
13) Rudolph R, et al: Myofibroblasts and free silicone around breast implants. Plas Reconstr Surg 62:185, 1978.
14) Bergman RB, van der Ende AE: Exudation of silicone through the envelope of gel-filled breast prostheses: An in vitro study. Br J Plas Surg 32:31, 1979.
15) Barnett MP: Triglyceride-filled breast implants. Plas Reconstr Surg 99:2105,1997.
16) Rizkalla M, Duncan C, Mathews RN: Trilucent breast implants: a 3 year series. Br J Plas Surg 54:125, 2001.
17) Choudhary S, Cadier MAM, Cottrell BJ: Local tissue reactions to oil-based breast implant bleed. Br J Plast Surg 53:317, 2000.
18) Papanastasiou S, Odili J, Newman P, et al: Are triglyceride breast implants really biocompatible? Ann Plas Surg 45:172, 2000.
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