PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
This device is manufactured by ALLERGAN (COSTA RICA), AMERICAN MEDICAL SYSTEMS.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Swollen Lymph Nodes/Glands | 1 | Patient |
| 2024 | Failure of Implant | 80 | Patient |
| 2024 | Capsular Contracture | 27 | Patient |
| 2024 | No Apparent Adverse Event | 2 | Device |
| 2024 | Material Rupture | 74 | Device |
| 2024 | Fluid/Blood Leak | 1 | Device |
| 2024 | Device Handling Problem | 1 | Device |
| 2024 | Device Appears to Trigger Rejection | 19 | Device |
| 2023 | Wound Dehiscence | 1 | Patient |
| 2023 | Unspecified Infection | 1 | Patient |
| 2023 | Seroma | 2 | Patient |
| 2023 | Failure of Implant | 71 | Patient |
| 2023 | Capsular Contracture | 23 | Patient |
| 2023 | No Apparent Adverse Event | 1 | Device |
| 2023 | Material Rupture | 80 | Device |
| 2023 | Gel Leak | 1 | Device |
| 2023 | Device Handling Problem | 1 | Device |
| 2023 | Device Appears to Trigger Rejection | 22 | Device |
| 2023 | Break | 1 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2022 | Swollen Lymph Nodes/Glands | 1 | Patient |
| 2022 | Failure of Implant | 14 | Patient |
| 2022 | Capsular Contracture | 4 | Patient |
| 2022 | Migration | 1 | Device |
| 2022 | Material Rupture | 65 | Device |
| 2022 | Gel Leak | 1 | Device |
| 2022 | Device Appears to Trigger Rejection | 18 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2021 | Failure of Implant | 7 | Patient |
| 2021 | Material Rupture | 21 | Device |
| 2021 | Device Appears to Trigger Rejection | 1 | Device |
| 2020 | Failure of Implant | 1 | Patient |
| 2020 | Capsular Contracture | 3 | Patient |
| 2020 | Material Rupture | 6 | Device |
| 2020 | Device Appears to Trigger Rejection | 4 | Device |
| 2019 | Patient-Device Incompatibility | 46 | Device |
| 2019 | Migration | 1 | Device |
| 2019 | Material Rupture | 146 | Device |
| 2019 | Gel Leak | 3 | Device |
| 2019 | Fluid/Blood Leak | 1 | Device |
| 2019 | Device Appears to Trigger Rejection | 1 | Device |
| 2019 | Adverse Event Without Identified Device or Use Problem | 5 | Device |
| 2018 | Failure of Implant | 1 | Patient |
| 2018 | Patient-Device Incompatibility | 27 | Device |
| 2018 | Material Rupture | 60 | Device |
| 2018 | Fluid/Blood Leak | 1 | Device |
| 2017 | Capsular Contracture | 1 | Patient |
| 2017 | Use of Device Problem | 1 | Device |
| 2017 | Patient-Device Incompatibility | 12 | Device |
| 2017 | Migration or Expulsion of Device | 3 | Device |
| 2017 | Material Rupture | 35 | Device |
| 2017 | Fluid/Blood Leak | 2 | Device |
| 2017 | Device Appears to Trigger Rejection | 1 | Device |
| 2016 | Capsular Contracture | 1 | Patient |
| 2016 | Patient-Device Incompatibility | 9 | Device |
| 2016 | Material Rupture | 12 | Device |
| 2016 | Device Appears to Trigger Rejection | 1 | Device |
| 2015 | Failure of Implant | 1 | Patient |
| 2015 | Material Rupture | 5 | Device |
| 2015 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2014 | Seroma | 1 | Patient |
| 2014 | Failure of Implant | 1 | Patient |
| 2014 | Capsular Contracture | 1 | Patient |
| 2014 | Breast Mass | 1 | Patient |
| 2014 | Patient-Device Incompatibility | 3 | Device |
| 2014 | Material Rupture | 7 | Device |
| 2014 | Device Appears to Trigger Rejection | 1 | Device |
| 2014 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2013 | Unspecified Infection | 1 | Patient |
| 2013 | Failure of Implant | 1 | Patient |
| 2013 | Capsular Contracture | 1 | Patient |
| 2013 | Material Rupture | 6 | Device |
| 2013 | Device Appears to Trigger Rejection | 1 | Device |
| 2012 | Unspecified Infection | 1 | Patient |
| 2012 | Failure of Implant | 1 | Patient |
| 2012 | No Apparent Adverse Event | 1 | Device |
| 2012 | Material Rupture | 7 | Device |
| 2012 | Adverse Event Without Identified Device or Use Problem | 3 | Device |
| 2011 | Capsular Contracture | 3 | Patient |
| 2011 | Material Rupture | 4 | Device |
| 2011 | Device Appears to Trigger Rejection | 4 | Device |
| 2011 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2010 | Failure of Implant | 1 | Patient |
| 2010 | Capsular Contracture | 2 | Patient |
| 2010 | Material Rupture | 3 | Device |
| 2010 | Device Appears to Trigger Rejection | 2 | Device |
| 2010 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2009 | Failure of Implant | 1 | Patient |
| 2009 | Material Rupture | 3 | Device |
| 2009 | Device Appears to Trigger Rejection | 2 | Device |
| 2007 | Patient-Device Incompatibility | 1 | Device |
| 2007 | Material Rupture | 1 | Device |
| 2006 | Patient-Device Incompatibility | 1 | Device |
| 2006 | Material Rupture | 4 | Device |
| 2005 | Patient-Device Incompatibility | 1 | Device |
| 2005 | Material Rupture | 1 | Device |
| 2004 | Patient-Device Incompatibility | 2 | Device |
| 2004 | Material Rupture | 1 | Device |
| 2003 | Patient-Device Incompatibility | 2 | Device |
| 2003 | Material Rupture | 2 | Device |