PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
This device is manufactured by ALLERGAN, ALLERGAN (COSTA RICA), INAMED AESTHETICS / ALLERGAN.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Unspecified Infection | 1 | Patient |
| 2024 | Swollen Lymph Nodes/Glands | 2 | Patient |
| 2024 | Seroma | 3 | Patient |
| 2024 | Failure of Implant | 151 | Patient |
| 2024 | Cognitive Changes | 1 | Patient |
| 2024 | Capsular Contracture | 60 | Patient |
| 2024 | No Apparent Adverse Event | 2 | Device |
| 2024 | Material Rupture | 148 | Device |
| 2024 | Device Handling Problem | 1 | Device |
| 2024 | Device Appears to Trigger Rejection | 46 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2023 | Unspecified Infection | 1 | Patient |
| 2023 | Seroma | 3 | Patient |
| 2023 | Granuloma | 2 | Patient |
| 2023 | Failure of Implant | 230 | Patient |
| 2023 | Capsular Contracture | 83 | Patient |
| 2023 | Peeled/Delaminated | 1 | Device |
| 2023 | No Apparent Adverse Event | 9 | Device |
| 2023 | Material Rupture | 233 | Device |
| 2023 | Gel Leak | 2 | Device |
| 2023 | Fluid/Blood Leak | 3 | Device |
| 2023 | Device Handling Problem | 1 | Device |
| 2023 | Device Appears to Trigger Rejection | 83 | Device |
| 2022 | Swollen Lymph Nodes/Glands | 2 | Patient |
| 2022 | Seroma | 3 | Patient |
| 2022 | Granuloma | 1 | Patient |
| 2022 | Failure of Implant | 40 | Patient |
| 2022 | Capsular Contracture | 18 | Patient |
| 2022 | Patient-Device Incompatibility | 1 | Device |
| 2022 | Material Rupture | 179 | Device |
| 2022 | Gel Leak | 3 | Device |
| 2022 | Device Appears to Trigger Rejection | 67 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2021 | Failure of Implant | 8 | Patient |
| 2021 | Cellulitis | 1 | Patient |
| 2021 | Capsular Contracture | 5 | Patient |
| 2021 | Patient-Device Incompatibility | 1 | Device |
| 2021 | No Apparent Adverse Event | 1 | Device |
| 2021 | Material Rupture | 39 | Device |
| 2021 | Device Appears to Trigger Rejection | 18 | Device |
| 2021 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2020 | Failure of Implant | 2 | Patient |
| 2020 | Patient-Device Incompatibility | 6 | Device |
| 2020 | Material Rupture | 19 | Device |
| 2020 | Device Appears to Trigger Rejection | 2 | Device |