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 4-6Â % | |
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; 75Â % negative | |
1993 | AMA: anxiety is not warranted based on current scientific evidence | |
1994 | Removal: augmentation frequencies increased from 9.2Â % to 73Â % | |
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 |