| Event . | Primary augmentation (n = 451) . | Revisional augmentation (n = 109) . |
|---|---|---|
| Reoperation | 27 (6.1%) | 27 (25.8%) |
| Explantation | 7 (1.6%) | 17 (16.5%) |
| Explantation with replacement | 6 (1.4%) | 14 (13.8%) |
| Explantation without replacement | 1 (0.2%) | 3 (2.9%) |
| Number of patients with at least 1 reoperation | 27 (6.0%) | 27 (24.8%) |
| Risk of any complicationa | 37 (8.4%) | 30 (28.4%) |
| Breast pain | 3 (0.7%) | 1 (1.0%) |
| Animation deformity | 1 (0.2%) | 0 |
| Asymmetry | 1 (0.2%) | 4 (3.9%) |
| Breast cancer (new) | 0 | 0 |
| Capsular contracture grade II with surgical intervention | 1 (0.2%) | 2 (1.9%) |
| Capsular contracture III/IV | 2 (0.5%) | 7 (6.7%) |
| BIA-ALCL | 0 | 0 |
| Double capsule | 0 | 1 (1.0%) |
| Infection | 4 (0.9%) | 1 (0.9%) |
| Rupture suspected/confirmed | 1 (0.6%) | 0 |
| Size change | 2 (6.9%) | 6 (20.7%) |
| Delayed wound healing | 1 (0.2%) | 0 |
| Hematoma | 3 (0.7%) | 2 (1.8%) |
| Iatrogenic injury to implant | 0 | 1 (1.0%) |
| Implant extrusion | 0 | 1 (1.0%) |
| Malposition | 14 (3.2) | 5 (4.9%) |
| Palpability/visibility | 1 (0.2%) | 0 |
| Breast mass/cyst/lump | 1 (0.2%) | 2 (2.4%) |
| Ptosis | 1 (0.2%) | 5 (4.8%) |
| Nipple complication | 1 (0.2%) | 0 |
| Skin rash | 1 (0.2%) | 0 |
| Seroma (late >1 year) | 0 | 0 |
| Wrinkling/rippling | 2 (0.5%) | 0 |
| Event . | Primary augmentation (n = 451) . | Revisional augmentation (n = 109) . |
|---|---|---|
| Reoperation | 27 (6.1%) | 27 (25.8%) |
| Explantation | 7 (1.6%) | 17 (16.5%) |
| Explantation with replacement | 6 (1.4%) | 14 (13.8%) |
| Explantation without replacement | 1 (0.2%) | 3 (2.9%) |
| Number of patients with at least 1 reoperation | 27 (6.0%) | 27 (24.8%) |
| Risk of any complicationa | 37 (8.4%) | 30 (28.4%) |
| Breast pain | 3 (0.7%) | 1 (1.0%) |
| Animation deformity | 1 (0.2%) | 0 |
| Asymmetry | 1 (0.2%) | 4 (3.9%) |
| Breast cancer (new) | 0 | 0 |
| Capsular contracture grade II with surgical intervention | 1 (0.2%) | 2 (1.9%) |
| Capsular contracture III/IV | 2 (0.5%) | 7 (6.7%) |
| BIA-ALCL | 0 | 0 |
| Double capsule | 0 | 1 (1.0%) |
| Infection | 4 (0.9%) | 1 (0.9%) |
| Rupture suspected/confirmed | 1 (0.6%) | 0 |
| Size change | 2 (6.9%) | 6 (20.7%) |
| Delayed wound healing | 1 (0.2%) | 0 |
| Hematoma | 3 (0.7%) | 2 (1.8%) |
| Iatrogenic injury to implant | 0 | 1 (1.0%) |
| Implant extrusion | 0 | 1 (1.0%) |
| Malposition | 14 (3.2) | 5 (4.9%) |
| Palpability/visibility | 1 (0.2%) | 0 |
| Breast mass/cyst/lump | 1 (0.2%) | 2 (2.4%) |
| Ptosis | 1 (0.2%) | 5 (4.8%) |
| Nipple complication | 1 (0.2%) | 0 |
| Skin rash | 1 (0.2%) | 0 |
| Seroma (late >1 year) | 0 | 0 |
| Wrinkling/rippling | 2 (0.5%) | 0 |
aDoes not include complications assessed as mild severity, except for capsular contracture III/IV, implant extrusion, and suspected or confirmed rupture. BIA-ALCL, breast implant–associated anaplastic large cell lymphoma.
| Event . | Primary augmentation (n = 451) . | Revisional augmentation (n = 109) . |
|---|---|---|
| Reoperation | 27 (6.1%) | 27 (25.8%) |
| Explantation | 7 (1.6%) | 17 (16.5%) |
| Explantation with replacement | 6 (1.4%) | 14 (13.8%) |
| Explantation without replacement | 1 (0.2%) | 3 (2.9%) |
| Number of patients with at least 1 reoperation | 27 (6.0%) | 27 (24.8%) |
| Risk of any complicationa | 37 (8.4%) | 30 (28.4%) |
| Breast pain | 3 (0.7%) | 1 (1.0%) |
| Animation deformity | 1 (0.2%) | 0 |
| Asymmetry | 1 (0.2%) | 4 (3.9%) |
| Breast cancer (new) | 0 | 0 |
| Capsular contracture grade II with surgical intervention | 1 (0.2%) | 2 (1.9%) |
| Capsular contracture III/IV | 2 (0.5%) | 7 (6.7%) |
| BIA-ALCL | 0 | 0 |
| Double capsule | 0 | 1 (1.0%) |
| Infection | 4 (0.9%) | 1 (0.9%) |
| Rupture suspected/confirmed | 1 (0.6%) | 0 |
| Size change | 2 (6.9%) | 6 (20.7%) |
| Delayed wound healing | 1 (0.2%) | 0 |
| Hematoma | 3 (0.7%) | 2 (1.8%) |
| Iatrogenic injury to implant | 0 | 1 (1.0%) |
| Implant extrusion | 0 | 1 (1.0%) |
| Malposition | 14 (3.2) | 5 (4.9%) |
| Palpability/visibility | 1 (0.2%) | 0 |
| Breast mass/cyst/lump | 1 (0.2%) | 2 (2.4%) |
| Ptosis | 1 (0.2%) | 5 (4.8%) |
| Nipple complication | 1 (0.2%) | 0 |
| Skin rash | 1 (0.2%) | 0 |
| Seroma (late >1 year) | 0 | 0 |
| Wrinkling/rippling | 2 (0.5%) | 0 |
| Event . | Primary augmentation (n = 451) . | Revisional augmentation (n = 109) . |
|---|---|---|
| Reoperation | 27 (6.1%) | 27 (25.8%) |
| Explantation | 7 (1.6%) | 17 (16.5%) |
| Explantation with replacement | 6 (1.4%) | 14 (13.8%) |
| Explantation without replacement | 1 (0.2%) | 3 (2.9%) |
| Number of patients with at least 1 reoperation | 27 (6.0%) | 27 (24.8%) |
| Risk of any complicationa | 37 (8.4%) | 30 (28.4%) |
| Breast pain | 3 (0.7%) | 1 (1.0%) |
| Animation deformity | 1 (0.2%) | 0 |
| Asymmetry | 1 (0.2%) | 4 (3.9%) |
| Breast cancer (new) | 0 | 0 |
| Capsular contracture grade II with surgical intervention | 1 (0.2%) | 2 (1.9%) |
| Capsular contracture III/IV | 2 (0.5%) | 7 (6.7%) |
| BIA-ALCL | 0 | 0 |
| Double capsule | 0 | 1 (1.0%) |
| Infection | 4 (0.9%) | 1 (0.9%) |
| Rupture suspected/confirmed | 1 (0.6%) | 0 |
| Size change | 2 (6.9%) | 6 (20.7%) |
| Delayed wound healing | 1 (0.2%) | 0 |
| Hematoma | 3 (0.7%) | 2 (1.8%) |
| Iatrogenic injury to implant | 0 | 1 (1.0%) |
| Implant extrusion | 0 | 1 (1.0%) |
| Malposition | 14 (3.2) | 5 (4.9%) |
| Palpability/visibility | 1 (0.2%) | 0 |
| Breast mass/cyst/lump | 1 (0.2%) | 2 (2.4%) |
| Ptosis | 1 (0.2%) | 5 (4.8%) |
| Nipple complication | 1 (0.2%) | 0 |
| Skin rash | 1 (0.2%) | 0 |
| Seroma (late >1 year) | 0 | 0 |
| Wrinkling/rippling | 2 (0.5%) | 0 |
aDoes not include complications assessed as mild severity, except for capsular contracture III/IV, implant extrusion, and suspected or confirmed rupture. BIA-ALCL, breast implant–associated anaplastic large cell lymphoma.
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