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Summary of global regulatory agency risk estimates of BIA-ALCL
| Country | Source | Risk |
|---|---|---|
| Australia | Australian Therapeutic Good Administration | 1:2,500–1:25,000 patients |
| Canada | Health Canada | Overall: 1:24,177; 1:3,565 (Allergan); 1:16,703 (Mentor) |
| United Kingdom | Medicines and Healthcare Products Regulatory Agency | 1:24,000 (implants) |
| United States | Food and Drug Administration | 1:3,817–1:30,000 |
BIA-ALCL, breast implant-associated anaplastic large cell lymphoma.
