PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
This device is manufactured by ALLERGAN (COSTA RICA).
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Unspecified Infection | 1 | Patient |
| 2024 | Swollen Lymph Nodes/Glands | 6 | Patient |
| 2024 | Seroma | 2 | Patient |
| 2024 | Failure of Implant | 157 | Patient |
| 2024 | Chest Pain | 1 | Patient |
| 2024 | Capsular Contracture | 76 | Patient |
| 2024 | Autoimmune Disorder | 1 | Patient |
| 2024 | No Apparent Adverse Event | 3 | Device |
| 2024 | Material Rupture | 145 | Device |
| 2024 | Gel Leak | 1 | Device |
| 2024 | Device Appears to Trigger Rejection | 62 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 3 | Device |
| 2023 | Unspecified Infection | 1 | Patient |
| 2023 | Seroma | 1 | Patient |
| 2023 | Failure of Implant | 118 | Patient |
| 2023 | Capsular Contracture | 51 | Patient |
| 2023 | Peeled/Delaminated | 2 | Device |
| 2023 | No Apparent Adverse Event | 2 | Device |
| 2023 | Migration | 2 | Device |
| 2023 | Material Rupture | 124 | Device |
| 2023 | Fluid/Blood Leak | 1 | Device |
| 2023 | Device Handling Problem | 2 | Device |
| 2023 | Device Appears to Trigger Rejection | 50 | Device |
| 2022 | Failure of Implant | 23 | Patient |
| 2022 | Capsular Contracture | 15 | Patient |
| 2022 | Patient-Device Incompatibility | 1 | Device |
| 2022 | Material Rupture | 112 | Device |
| 2022 | Gel Leak | 1 | Device |
| 2022 | Fluid/Blood Leak | 2 | Device |
| 2022 | Device Handling Problem | 2 | Device |
| 2022 | Device Appears to Trigger Rejection | 60 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 3 | Device |
| 2021 | Failure of Implant | 4 | Patient |
| 2021 | Capsular Contracture | 5 | Patient |
| 2021 | Patient-Device Incompatibility | 2 | Device |
| 2021 | Material Rupture | 20 | Device |
| 2021 | Fluid/Blood Leak | 1 | Device |
| 2021 | Device Appears to Trigger Rejection | 15 | Device |
| 2020 | Capsular Contracture | 1 | Patient |
| 2020 | Patient-Device Incompatibility | 4 | Device |
| 2020 | Material Rupture | 4 | Device |
| 2020 | Device Appears to Trigger Rejection | 3 | Device |
| 2020 | Adverse Event Without Identified Device or Use Problem | 1 | Device |