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 | 2 | Patient |
| 2024 | Swollen Lymph Nodes/Glands | 17 | Patient |
| 2024 | Seroma | 27 | Patient |
| 2024 | Pocket Erosion | 1 | Patient |
| 2024 | Lymphoma | 4 | Patient |
| 2024 | Granuloma | 3 | Patient |
| 2024 | Foreign Body Reaction | 2 | Patient |
| 2024 | Failure of Implant | 139 | Patient |
| 2024 | Erosion | 1 | Patient |
| 2024 | Capsular Contracture | 98 | Patient |
| 2024 | Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA ALCL) | 2 | Patient |
| 2024 | Anxiety | 1 | Patient |
| 2024 | Patient-Device Incompatibility | 2 | Device |
| 2024 | No Apparent Adverse Event | 6 | Device |
| 2024 | Migration | 3 | Device |
| 2024 | Material Rupture | 136 | Device |
| 2024 | Gel Leak | 1 | Device |
| 2024 | Device Appears to Trigger Rejection | 79 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 19 | Device |
| 2023 | Unspecified Infection | 3 | Patient |
| 2023 | Swollen Lymph Nodes/Glands | 20 | Patient |
| 2023 | Seroma | 55 | Patient |
| 2023 | Necrosis | 1 | Patient |
| 2023 | Lymphoma | 4 | Patient |
| 2023 | Granuloma | 18 | Patient |
| 2023 | Failure of Implant | 232 | Patient |
| 2023 | Capsular Contracture | 148 | Patient |
| 2023 | Breast Mass | 1 | Patient |
| 2023 | Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA ALCL) | 5 | Patient |
| 2023 | Abscess | 1 | Patient |
| 2023 | Peeled/Delaminated | 1 | Device |
| 2023 | No Apparent Adverse Event | 6 | Device |
| 2023 | Migration | 11 | Device |
| 2023 | Material Rupture | 271 | Device |
| 2023 | Gel Leak | 3 | Device |
| 2023 | Device Handling Problem | 1 | Device |
| 2023 | Device Appears to Trigger Rejection | 134 | Device |
| 2023 | Biofilm coating in Device | 1 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 24 | Device |
| 2022 | Swollen Lymph Nodes/Glands | 9 | Patient |
| 2022 | Skin Inflammation/ Irritation | 1 | Patient |
| 2022 | Seroma | 11 | Patient |
| 2022 | Lymphoma | 1 | Patient |
| 2022 | Granuloma | 4 | Patient |
| 2022 | Foreign Body Reaction | 1 | Patient |
| 2022 | Failure of Implant | 57 | Patient |
| 2022 | Capsular Contracture | 35 | Patient |
| 2022 | Calcium Deposits/Calcification | 1 | Patient |
| 2022 | Patient-Device Incompatibility | 4 | Device |
| 2022 | No Apparent Adverse Event | 3 | Device |
| 2022 | Migration | 15 | Device |
| 2022 | Material Rupture | 230 | Device |
| 2022 | Gel Leak | 1 | Device |
| 2022 | Fluid/Blood Leak | 2 | Device |
| 2022 | Device Handling Problem | 3 | Device |
| 2022 | Device Dislodged or Dislocated | 1 | Device |
| 2022 | Device Appears to Trigger Rejection | 114 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 25 | Device |
| 2021 | Swollen Lymph Nodes/Glands | 1 | Patient |
| 2021 | Seroma | 6 | Patient |
| 2021 | Granuloma | 1 | Patient |
| 2021 | Failure of Implant | 15 | Patient |
| 2021 | Capsular Contracture | 15 | Patient |
| 2021 | Patient-Device Incompatibility | 3 | Device |
| 2021 | Migration | 2 | Device |
| 2021 | Material Rupture | 61 | Device |
| 2021 | Gel Leak | 2 | Device |
| 2021 | Fluid/Blood Leak | 1 | Device |
| 2021 | Device Appears to Trigger Rejection | 41 | Device |
| 2021 | Adverse Event Without Identified Device or Use Problem | 12 | Device |
| 2020 | Swollen Lymph Nodes/Glands | 1 | Patient |
| 2020 | Seroma | 7 | Patient |
| 2020 | Granuloma | 3 | Patient |
| 2020 | Failure of Implant | 5 | Patient |
| 2020 | Capsular Contracture | 18 | Patient |
| 2020 | Patient-Device Incompatibility | 15 | Device |
| 2020 | No Apparent Adverse Event | 7 | Device |
| 2020 | Migration | 6 | Device |
| 2020 | Material Rupture | 46 | Device |
| 2020 | Insufficient Information | 1 | Device |
| 2020 | Improper or Incorrect Procedure or Method | 1 | Device |
| 2020 | Device Handling Problem | 2 | Device |
| 2020 | Device Appears to Trigger Rejection | 21 | Device |
| 2020 | Adverse Event Without Identified Device or Use Problem | 12 | Device |