Table 8.
Subsequent Breast Operation | Value (%) |
---|---|
Primary augmentation | |
No. | 179 |
Reason | |
Dissatisfaction with implant size | 24 (13.4) |
Inadequate saline volumea | 11 (6.1) |
Baker class III or IV capsular contracture | 11 (6.1) |
Wrinkling/scalloping: moderate or severe | 10 (5.6) |
Implant position unsatisfactory | 5 (2.8) |
Breast lesion: benign or malignant | 9 (5.0) |
Spontaneous deflation | 12 (6.7) |
Revision augmentation | |
No. | 77 |
Reason | |
Implant exposure/extrusionb | 8 (10.4) |
Dissatisfaction with implant size | 10 (13.0) |
Inadequate saline volumea | 6 (7.8) |
Wrinkling/scalloping | 8 (10.4) |
Baker class III or IV capsular contracture | 6 (7.8) |
Dissatisfaction with cosmetic result | 4 (5.2) |
Spontaneous deflation | 1 (1.3) |
Inadequate saline volume was observed very early in the course of the trial and addressed by increasing the minimum and maximum fill volumes for the outer lumen to those shown in Table 1.
One patient had implant exposure related to an infection; one patient had three implant exposures associated with multiple operations related to poor wound healing.