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 | Swollen Lymph Nodes/Glands | 3 | Patient |
| 2024 | Seroma | 15 | Patient |
| 2024 | Granuloma | 1 | Patient |
| 2024 | Failure of Implant | 66 | Patient |
| 2024 | Capsular Contracture | 34 | Patient |
| 2024 | Anxiety | 1 | Patient |
| 2024 | Migration | 1 | Device |
| 2024 | Material Rupture | 64 | Device |
| 2024 | Device Appears to Trigger Rejection | 27 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 3 | Device |
| 2023 | Unspecified Infection | 1 | Patient |
| 2023 | Swollen Lymph Nodes/Glands | 3 | Patient |
| 2023 | Seroma | 13 | Patient |
| 2023 | Necrosis | 1 | Patient |
| 2023 | Lymphoma | 2 | Patient |
| 2023 | Granuloma | 3 | Patient |
| 2023 | Failure of Implant | 87 | Patient |
| 2023 | Capsular Contracture | 21 | Patient |
| 2023 | No Apparent Adverse Event | 1 | Device |
| 2023 | Migration | 1 | Device |
| 2023 | Material Rupture | 100 | Device |
| 2023 | Device Handling Problem | 1 | Device |
| 2023 | Device Appears to Trigger Rejection | 23 | Device |
| 2023 | Appropriate Term/Code Not Available | 2 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 5 | Device |
| 2022 | Swollen Lymph Nodes/Glands | 2 | Patient |
| 2022 | Seroma | 2 | Patient |
| 2022 | Granuloma | 1 | Patient |
| 2022 | Failure of Implant | 20 | Patient |
| 2022 | Capsular Contracture | 5 | Patient |
| 2022 | Patient-Device Incompatibility | 1 | Device |
| 2022 | No Apparent Adverse Event | 1 | Device |
| 2022 | Migration | 4 | Device |
| 2022 | Material Rupture | 90 | Device |
| 2022 | Fluid/Blood Leak | 1 | Device |
| 2022 | Device Appears to Trigger Rejection | 25 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 6 | Device |
| 2021 | Seroma | 2 | Patient |
| 2021 | Failure of Implant | 6 | Patient |
| 2021 | Capsular Contracture | 2 | Patient |
| 2021 | Patient-Device Incompatibility | 1 | Device |
| 2021 | Material Rupture | 24 | Device |
| 2021 | Insufficient Information | 1 | Device |
| 2021 | Device Appears to Trigger Rejection | 8 | Device |
| 2021 | Adverse Event Without Identified Device or Use Problem | 3 | Device |
| 2020 | Patient-Device Incompatibility | 9 | Device |
| 2020 | Material Rupture | 14 | Device |
| 2020 | Adverse Event Without Identified Device or Use Problem | 6 | Device |
| 2019 | Seroma | 2 | Patient |
| 2019 | Failure of Implant | 2 | Patient |
| 2019 | Capsular Contracture | 6 | Patient |
| 2019 | Patient-Device Incompatibility | 100 | Device |
| 2019 | No Apparent Adverse Event | 1 | Device |
| 2019 | Migration | 4 | Device |
| 2019 | Material Rupture | 210 | Device |
| 2019 | Improper or Incorrect Procedure or Method | 1 | Device |
| 2019 | Gel Leak | 1 | Device |
| 2019 | Fluid/Blood Leak | 1 | Device |
| 2019 | Device Appears to Trigger Rejection | 7 | Device |
| 2019 | Break | 1 | Device |
| 2019 | Adverse Event Without Identified Device or Use Problem | 18 | Device |
| 2018 | Failure of Implant | 1 | Patient |
| 2018 | Patient-Device Incompatibility | 18 | Device |
| 2018 | Material Rupture | 38 | Device |
| 2018 | Gel Leak | 1 | Device |
| 2018 | Adverse Event Without Identified Device or Use Problem | 5 | Device |
| 2017 | Seroma | 1 | Patient |
| 2017 | Failure of Implant | 3 | Patient |
| 2017 | Patient-Device Incompatibility | 4 | Device |
| 2017 | No Apparent Adverse Event | 2 | Device |
| 2017 | Migration | 2 | Device |
| 2017 | Material Rupture | 14 | Device |
| 2017 | Fluid/Blood Leak | 2 | Device |
| 2017 | Adverse Event Without Identified Device or Use Problem | 6 | Device |
| 2016 | Patient-Device Incompatibility | 4 | Device |
| 2016 | No Apparent Adverse Event | 2 | Device |
| 2016 | Migration | 1 | Device |
| 2016 | Material Rupture | 3 | Device |
| 2016 | Malposition of Device | 1 | Device |
| 2016 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2015 | Failure of Implant | 1 | Patient |
| 2015 | Capsular Contracture | 3 | Patient |
| 2015 | Patient-Device Incompatibility | 1 | Device |
| 2015 | Material Rupture | 2 | Device |
| 2015 | Malposition of Device | 1 | Device |
| 2015 | Device Appears to Trigger Rejection | 2 | Device |
| 2015 | Adverse Event Without Identified Device or Use Problem | 3 | Device |
| 2014 | Patient-Device Incompatibility | 1 | Device |
| 2014 | Material Rupture | 3 | Device |
| 2014 | Adverse Event Without Identified Device or Use Problem | 4 | Device |
| 2013 | Seroma | 1 | Patient |
| 2013 | Capsular Contracture | 3 | Patient |
| 2013 | Material Rupture | 2 | Device |
| 2013 | Device Appears to Trigger Rejection | 3 | Device |
| 2013 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2012 | Patient-Device Incompatibility | 2 | Device |
| 2012 | Material Rupture | 2 | Device |
| 2012 | Adverse Event Without Identified Device or Use Problem | 4 | Device |
| 2011 | Capsular Contracture | 2 | Patient |
| 2011 | Patient-Device Incompatibility | 1 | Device |
| 2011 | Material Rupture | 2 | Device |
| 2011 | Device Appears to Trigger Rejection | 2 | Device |
| 2011 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2010 | Patient-Device Incompatibility | 2 | Device |
| 2010 | Device Appears to Trigger Rejection | 1 | Device |
| 2009 | Patient-Device Incompatibility | 1 | Device |
| 2009 | Material Rupture | 2 | Device |
| 2009 | Device Appears to Trigger Rejection | 2 | Device |
| 2009 | Adverse Event Without Identified Device or Use Problem | 1 | Device |