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Table 2 Key events surrounding FDA moratorium on SGBI

From: Halo and spillover effect illustrations for selected beneficial medical devices and drugs

Product Year Event
SGBI 1960s- 1980s SGBI used for breast augmentation and reconstruction (1 million estimated)
1976 Amendment to FDA Cosmetic Act: FDA authority to regulate implants
1980s-1990s Capsular contracture most commonly reported problem, rupture rate 4-6 %
1982 Case reports: connective-tissue disease in 3 Australians; lawsuit ensues
1988 Breast implants- Class III devices: MFs must document safety, efficacy
1990 Media publicizes concerns, blames FDA for permitting devices
1991 FDA limits access, MFs must provide positive demonstration of safety; FDA acknowledges limited evidence for disease
1992-1993 >2000 articles published on SGBI-related disease issues; 75 % negative
1993 AMA: anxiety is not warranted based on current scientific evidence
1994 Removal: augmentation frequencies increased from 9.2 % to 73 %
1995-1999 Medical Groups: association between SGBI, connective tissue diseases not proven
2011 FDA concludes SGBI have reasonable assurance of safety and effectiveness when used as labeled