Permanent Injectables for Soft Tissue Augmentation

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Food and Drug Administration Hylaform (Hylan B Gel). Rockville, Md: US Dept of Health and Human Services, Public Health Service; April 22, 2004. Premarket Approval Letter, Application P030032

Food and Drug Administration Restylane Injectable Gel. Rockville, Md: US Dept of Health and Human Services, Public Health Service; December 12, 2003. Premarket Approval Letter, Application P020023

Food and Drug Administration Sculptra (Injectable Poly-l-lactic Acid). Rockville, Md: US Dept of Health and Human Services, Public Health Service; August 3, 2004. Premarket Approval Letter, Application P030050

Food and Drug Administration CosmoDerm I Human-Based Collagen, CosmoDerm 2 Human-Based Collagen, and CosmoPlast Human-Based Collagen. Rockville, Md: US Dept of Health and Human Services, Public Health Service; March 11, 2003. Preclinical Review, Application P80022/S50

Food and Drug Administration Artecoll PMMA/Collagen Implant. Rockville, Md: General and Plastic Surgery Advisory Panel; February 28, 2003. Application P020012

Lemperle G , Hazan-Gauthier N , Lemperle M . PMMA microspheres (Artecoll) for skin and soft tissue augmentation, II: clinical investigations. Plast Reconstr Surg. 1995; 96:627-634. 7638287

Radiance FN Injectable Implant [package insert]. Franksville, Wis: BioForm Inc; 2003

Nassif PS . New technologies update: Radiance, an injectable calcium hydroxylapatite. Facial Plastic Times. September 2003:12

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Noone RB . A review of the possible health implications of silicone breast implants. Cancer. 1997; 79:1747-1756. 9128992

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Nyren O , Yin L , Josefsson S , et al. Risk of connective tissue disease and related disorders among women with breast implants: a nation-wide retrospective cohort study in Sweden. BMJ. 1998; 316:417-422. 9492663

Sanchez-Guerrero J , Colditz GA , Karlson EW , Hunter DJ , Speizer FE , Liang MH . Silicone breast implants and the risk of connective tissue diseases and symptoms. N Engl J Med. 1995; 332:1666-1670

Gabriel SE , O’Fallon WM , Kurland LT , Beard CM , Woods JE , Melton LJ III. Risk of connective tissue diseases and other disorders after breast implantation. N Engl J Med. 1994; 330:1697-1702. 8190133

Friis S , Mellemkjaer L , McLaughlin JK , et al. Connective tissue disease and other rheumatic conditions following breast implants in Denmark. Ann Plast Surg. 1997; 39:1-8. 9229085

Miller AS , Willard V , Kline K , et al. Absence of longitudinal changes in rheumatologic parameters after silicone breast implantation: a prospective 13-year study. Plast Reconstr Surg. 1998; 102:2299-2303. 9858162

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; 342:781-790. 10717013

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Tugwell P , Wells G , Peterson J , et al. Do silicone breast implants cause rheumatologic disorders? a systematic review for a court-appointed national science panel. Arthritis Rheum. 2001; 44:2477-2484. 11710703

Marwick C . Are they real? IOM report on breast implant problems: Institute of Medicine . JAMA. 1999; 282:314-315. 10432016

Spiers EM , Grotting JC , Omura EF . An epidermal proliferative reaction associated with a silicone gel breast implant. Am J Dermatopathol. 1994; 16:315-319. 7943642

Kuiper DH . Silicone granulomatous disease of the breast simulating cancer. Mich Med. 1973; 72:215-218. 4688223

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