Table 5.
Key KM Risk Rates through 10 Years, per Patient
| Primary Augmentationa | Revision Augmentationa | |
|---|---|---|
| No. | 399 | 103 |
| Adverse event, % | ||
| Subsequent breast operationb | 39.4 (34.4–44.9) | 50.3 (40.4–61.1) |
| Implant removal with or without replacementb | 32.1 (27.4–37.5) | 42.6 (33.1–53.6) |
| Wrinkling/scalloping: moderate or severe | 9.0 (6.5–12.4) | 21.1 (14.1–30.9) |
| Dissatisfaction with cosmetic results | 11.4 (8.5–15.2) | 15.6 (9.7–24.5) |
| Dissatisfaction with implant size selected | 9.3 (6.5–13.1) | 13.6 (8.1–22.4) |
| Baker class III or IV capsular contracture | 6.6 (4.5–9.6) | 11.5 (6.5–19.7) |
| Breast lesion: benign | 6.6 (4.5–9.7) | 7.6 (3.7–15.4) |
| Breast ptosis: after implant procedure | 4.4 (2.7–7.1) | 6.2 (2.9–13.4) |
| Spontaneous deflationb | 3.7 (2.1–6.4) | 4.7 (1.8–12.2) |
a
Values in parentheses are 95% CIs.
b
The KM rates for these three events are based on patients initially implanted bilaterally with correct size valve attachment component implants: n = 363 for primary augmentation and n = 93 for revision augmentation. Excluded were the 36 primary augmentation and 10 revision augmentation patients who received an implant with the incorrect size valve attachment component. Also excluded from these three events were spontaneous deflations because of implants with pilot manufacturing site defects.