PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
This device is manufactured by MENTOR MEDICAL SYSTEM BV.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Wrinkling | 18 | Patient |
| 2024 | Unspecified Reproductive System or Breast Problem | 4 | Patient |
| 2024 | Swollen Lymph Nodes/Glands | 3 | Patient |
| 2024 | Skin Inflammation/ Irritation | 1 | Patient |
| 2024 | Seroma | 3 | Patient |
| 2024 | Post Operative Wound Infection | 10 | Patient |
| 2024 | Paresthesia | 6 | Patient |
| 2024 | Pain | 1 | Patient |
| 2024 | Local Reaction | 9 | Patient |
| 2024 | Insufficient Information | 4 | Patient |
| 2024 | Impaired Healing | 2 | Patient |
| 2024 | Hematoma | 10 | Patient |
| 2024 | Granuloma | 3 | Patient |
| 2024 | Deformity/ Disfigurement | 445 | Patient |
| 2024 | Cyst(s) | 3 | Patient |
| 2024 | Capsular Contracture | 387 | Patient |
| 2024 | Calcium Deposits/Calcification | 5 | Patient |
| 2024 | Breast Mass | 14 | Patient |
| 2024 | Breast Discomfort/Pain | 33 | Patient |
| 2024 | Breast Cancer | 9 | Patient |
| 2024 | Autoimmune Disorder | 4 | Patient |
| 2024 | Appropriate Term / Code Not Available | 47 | Patient |
| 2024 | Use of Device Problem | 3 | Device |
| 2024 | No Apparent Adverse Event | 2 | Device |
| 2024 | Migration | 24 | Device |
| 2024 | Material Rupture | 419 | Device |
| 2024 | Material Discolored | 5 | Device |
| 2024 | Material Deformation | 2 | Device |
| 2024 | Gel Leak | 5 | Device |
| 2024 | Device Contamination with Chemical or Other Material | 4 | Device |
| 2024 | Appropriate Term/Code Not Available | 14 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 342 | Device |
| 2023 | Wrinkling | 14 | Patient |
| 2023 | Unspecified Reproductive System or Breast Problem | 4 | Patient |
| 2023 | Thrombosis/Thrombus | 1 | Patient |
| 2023 | Swollen Lymph Nodes/Glands | 6 | Patient |
| 2023 | Skin Inflammation/ Irritation | 10 | Patient |
| 2023 | Seroma | 20 | Patient |
| 2023 | Scar Tissue | 2 | Patient |
| 2023 | Post Operative Wound Infection | 18 | Patient |
| 2023 | Pocket Erosion | 4 | Patient |
| 2023 | Paresthesia | 8 | Patient |
| 2023 | Pain | 6 | Patient |
| 2023 | Necrosis | 2 | Patient |
| 2023 | Local Reaction | 21 | Patient |
| 2023 | Insufficient Information | 12 | Patient |
| 2023 | Impaired Healing | 4 | Patient |
| 2023 | Hematoma | 12 | Patient |
| 2023 | Granuloma | 18 | Patient |
| 2023 | Emotional Changes | 1 | Patient |
| 2023 | Deformity/ Disfigurement | 751 | Patient |
| 2023 | Cyst(s) | 16 | Patient |
| 2023 | Crushing Injury | 6 | Patient |
| 2023 | Capsular Contracture | 761 | Patient |
| 2023 | Calcium Deposits/Calcification | 6 | Patient |
| 2023 | Breast Mass | 17 | Patient |
| 2023 | Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA ALCL) | 1 | Patient |
| 2023 | Breast Discomfort/Pain | 96 | Patient |
| 2023 | Breast Cancer | 5 | Patient |
| 2023 | Appropriate Term / Code Not Available | 63 | Patient |
| 2023 | Abscess | 1 | Patient |
| 2023 | Use of Device Problem | 5 | Device |
| 2023 | Unsealed Device Packaging | 1 | Device |
| 2023 | No Apparent Adverse Event | 1 | Device |
| 2023 | Migration | 32 | Device |
| 2023 | Material Rupture | 814 | Device |
| 2023 | Material Integrity Problem | 1 | Device |
| 2023 | Material Discolored | 7 | Device |
| 2023 | Material Deformation | 2 | Device |
| 2023 | Gel Leak | 9 | Device |
| 2023 | Device Contamination with Chemical or Other Material | 2 | Device |
| 2023 | Appropriate Term/Code Not Available | 51 | Device |
| 2023 | Air/Gas in Device | 2 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 704 | Device |
| 2022 | Wrinkling | 6 | Patient |
| 2022 | Swollen Lymph Nodes/Glands | 2 | Patient |
| 2022 | Skin Inflammation/ Irritation | 1 | Patient |
| 2022 | Seroma | 1 | Patient |
| 2022 | Scar Tissue | 4 | Patient |
| 2022 | Post Operative Wound Infection | 9 | Patient |
| 2022 | Pocket Erosion | 2 | Patient |
| 2022 | Paresthesia | 2 | Patient |
| 2022 | Pain | 2 | Patient |
| 2022 | Necrosis | 1 | Patient |
| 2022 | Local Reaction | 7 | Patient |
| 2022 | Insufficient Information | 3 | Patient |
| 2022 | Hemorrhage/Blood Loss/Bleeding | 1 | Patient |
| 2022 | Hematoma | 3 | Patient |
| 2022 | Granuloma | 12 | Patient |
| 2022 | Deformity/ Disfigurement | 162 | Patient |
| 2022 | Cyst(s) | 12 | Patient |
| 2022 | Crushing Injury | 1 | Patient |
| 2022 | Capsular Contracture | 213 | Patient |
| 2022 | Cancer | 3 | Patient |
| 2022 | Calcium Deposits/Calcification | 3 | Patient |
| 2022 | Breast Mass | 8 | Patient |
| 2022 | Breast Discomfort/Pain | 28 | Patient |
| 2022 | Breast Cancer | 2 | Patient |
| 2022 | Autoimmune Disorder | 6 | Patient |
| 2022 | Appropriate Term / Code Not Available | 37 | Patient |
| 2022 | Use of Device Problem | 9 | Device |
| 2022 | Off-Label Use | 3 | Device |
| 2022 | No Apparent Adverse Event | 3 | Device |
| 2022 | Migration | 50 | Device |
| 2022 | Microbial Contamination of Device | 1 | Device |
| 2022 | Material Rupture | 777 | Device |
| 2022 | Material Discolored | 4 | Device |
| 2022 | Material Deformation | 1 | Device |
| 2022 | Gel Leak | 7 | Device |
| 2022 | Device Contamination with Chemical or Other Material | 1 | Device |
| 2022 | Defective Device | 4 | Device |
| 2022 | Appropriate Term/Code Not Available | 34 | Device |
| 2022 | Air/Gas in Device | 2 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 774 | Device |
| 2021 | Wrinkling | 3 | Patient |
| 2021 | Unspecified Reproductive System or Breast Problem | 2 | Patient |
| 2021 | Skin Inflammation/ Irritation | 1 | Patient |
| 2021 | Pain | 4 | Patient |
| 2021 | Local Reaction | 1 | Patient |
| 2021 | Granuloma | 1 | Patient |
| 2021 | Deformity/ Disfigurement | 23 | Patient |
| 2021 | Cyst(s) | 1 | Patient |
| 2021 | Capsular Contracture | 36 | Patient |
| 2021 | Calcium Deposits/Calcification | 2 | Patient |
| 2021 | Breast Mass | 2 | Patient |
| 2021 | Breast Discomfort/Pain | 4 | Patient |
| 2021 | Appropriate Term / Code Not Available | 11 | Patient |
| 2021 | Use of Device Problem | 2 | Device |
| 2021 | Off-Label Use | 1 | Device |
| 2021 | Migration | 9 | Device |
| 2021 | Material Rupture | 128 | Device |
| 2021 | Material Discolored | 1 | Device |
| 2021 | Appropriate Term/Code Not Available | 14 | Device |
| 2021 | Adverse Event Without Identified Device or Use Problem | 184 | Device |
| 2020 | Wrinkling | 1 | Patient |
| 2020 | Scar Tissue | 1 | Patient |
| 2020 | Post Operative Wound Infection | 1 | Patient |
| 2020 | Paresthesia | 5 | Patient |
| 2020 | Pain | 1 | Patient |
| 2020 | Granuloma | 2 | Patient |
| 2020 | Deformity/ Disfigurement | 2 | Patient |
| 2020 | Capsular Contracture | 24 | Patient |
| 2020 | Breast Mass | 2 | Patient |
| 2020 | Breast Discomfort/Pain | 4 | Patient |
| 2020 | Breast Cancer | 1 | Patient |
| 2020 | Autoimmune Disorder | 3 | Patient |
| 2020 | Appropriate Term / Code Not Available | 12 | Patient |
| 2020 | Use of Device Problem | 1 | Device |
| 2020 | Migration | 8 | Device |
| 2020 | Material Rupture | 44 | Device |
| 2020 | Gel Leak | 2 | Device |
| 2020 | Appropriate Term/Code Not Available | 3 | Device |
| 2020 | Adverse Event Without Identified Device or Use Problem | 52 | Device |