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- S L Spear and S Mardini.
- Division of Plastic Surgery, Georgetown University Medical Center, Washington, DC 20007-2197, USA. Spears@GUNET.Georgetown.edu
- Clin Plast Surg. 2001 Jul 1;28(3):435-43.
AbstractDespite ample evidence that silicone gel-filled implants do not cause systemic illness, they are still not available in the United States for widespread use. At this point, saline-filled implants are widely available for use, and assuming favorable outcomes of the relevant silicone studies, some forms of silicone gel-filled implants could be approved by the FDA and be available as soon as 2003. Other products under preliminary consideration by the FDA for eventual studies include the 150 series and the cohesive silicone gel-filled 410 series by McGhan, and the NovaGold implant by NovaMed. Assuming favorable study results, one or more could be approved by the FDA by the year 2004. Any products not yet submitted to the FDA for review of study designs by this time are not likely to be available in the United States in the next 4 or 5 years.
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