Complications rates reported In The Allergan Core Study for Primary Augmentation with INAMED® Silicone Breast Implants are shown below.
Primary Augmentation: Complications
| Complication* N=455 Patients | 4-year Complication Rate by Patient |
| Reoperation | 23.5% |
| Capsular Contracture III/IV | 13.2% |
| Breast Pain | 8.2% |
| Swelling | 7.8% |
| Implant Removal with Replacement | 7.5% |
| Nipple Complications | 4.9% |
| Implant Malposition | 4.1% |
| Scarring/Hypertrophic Scarring | 3.7% |
| Asymmetry | 3.2% |
| Implant Rupture (MRI cohort)** | 2.7% |
| Implant Removal without Replacement | 2.3% |
| Hematoma | 1.6% |
| Ptosis (sagging) | 1.4% |
| Breast/Skin Sensation Changes | 1.4% |
| Seroma/Fluid Accumulation | 1.3% |
| Bruising, Delayed Wound Healing, Extrusion of Intact Implant, Implant Palpability | <1% |
| isibility, Infection, Redness, Skin Rash, Tissue/Skin Necrosis, Wrinkling, Capsule Calcification, Irritation, Lymphadenopathy, Lymphedema, Other Complications, Pneumothorax | 0% |
*Most events were assessed with severity ratings, and the rates shown in the table
include only complications rated moderate, severe or very severe (excludes mild and
very mild ratings). All occurrences of reoperation, implant removal, implant rupture,
implant extrusion and pneumothorax are included.
**There was one patient with a suspected rupture of one of her implants. This rupture
has not yet been confirmed with removal and visual inspection of the implant.
Complications rates reported In The Allergan Core Study for Revision Augmentation with INAMED® Silicone Breast Implants are shown below.
Revision-Augmentation: Complications
| Complication* N=455 Patients | 4-year Complication Rate by Patient |
| Reoperation | 35.3% |
| Capsular Contracture III/IV | 17.0% |
| Implant Removal with Replacemen | 10.5% |
| Breast Pain | 7.8% |
| Swelling | 6.4% |
| Scarring/Hypertrophic Scarring | 6.1% |
| Implant Palpability/Visibility | 6.0% |
| Asymmetry | 5.1% |
| Seroma/Fluid Accumulation | 5.0% |
| Implant Malpositio | 4.6% |
| Implant Rupture (MRI cohort)** | 4.0% |
| Wrinkling | 3.9% |
| Implant Removal without Replacement | 3.1% |
| Ptosis (sagging) | 3.1% |
| Bruising | 2.1% |
| Hematoma | 2.1% |
| Infection | 1.4% |
| Skin Sensation Changes | 1.4% |
| Delayed Wound Healing, Irritation, Other Complications, Redness, Skin Rash, Capsule Calcification, Extrusion of Intact Implant, Lymphadenopathy, Lymphedema, Nipple Sensation Changes,Other Nipple Related Observation, Pneumothorax, Tissue/Skin Necrosis |
*Most events were assessed with severity ratings, and the rates shown in the table
include only complications rated moderate, severe or very severe (excludes mild and
very mild ratings). All occurrences of reoperation, implant removal, implant rupture,
implant extrusion and pneumothorax are included.
**There were two patients with a suspected rupture in one of their implants. These two
ruptures have not yet been confirmed with removal and visual inspection of the implants.
