Table 4.
Summary of the Initial Presentation, Treatment, and Treatment Response of Fatal Adverse Events, Where Specified
| Adverse Event Presentation, Treatment, and Treatment Response, Where Specified | ||
|---|---|---|
| Adverse Event | Initial Presentation | Treatment and Treatment Response |
| BIA-ALCL (n = 21) | Mass ± metastatic disease (n = 8, 38%) Seroma/effusion (n = 6, 29%) Swelling/breast enlargement (n = 3, 14%) Lymphadenopathy (supraclavicular, axillary) (n = 3, 14%) Capsular contracture (n = 1, 5%) Cutaneous changes (n = 2, 10%) Not specified (n = 8, 38%) |
Surgery (implant removal ± capsulectomy) + Chemotherapy (n = 7, 33%) Unspecified response (n = 7, 100%) Surgery (implant removal ± capsulectomy) (n = 4, 19%) Unspecified response (n = 4, 100%) Chemotherapy (n = 3, 14%) Poor treatment response (n = 1, 33%) Unspecified response (n = 2, 67%) Surgery (implant removal ± capsulectomy) + Chemotherapy + mastectomy (n = 1, 5%)Poor response (n = 1, 100%) Not specified (n = 6, 29%) |
| Unspecified lymphoma (n = 3) | Shortness of breath, capsular contracture, breast pain, and swelling, lymphadenopathy (n = 1, 33%) Not specified (n = 2, 67%) |
Surgery (implant removal + chemotherapy (n = 1, 33%)Moderate response (complications) (n = 1, 100%) Not specified (n = 2, 67%) |
| Breast cancer (n = 2) | Severe diarrhea and dehydration (n = 1, 50%) Not specified (n = 1, 50%) |
Steroids for suspected sarcoidosis (n = 1, 50%) Poor response (n = 1, 100%) Radiation therapy (n = 1, 50%) Unspecified response (n = 1, 100%) |
| Sepsis; toxic shock syndrome (n = 1) | Discomfort, pain, swelling, and inflammation (n = 1, 100%) | Not specified (n = 1, 100%) |
| Rupture, suspected silicone leak, and systemic migration; invasive breast ductal carcinoma (n = 1) | Capsular contracture, pain, lymphadenopathy, dysesthesia, gait, bowel and cognitive dysfunction (n = 1, 100%) | Surgery (implant removal) (n = 1, 100%) Poor response (n = 1, 100%) |
| Infection (n = 1) | Not specified (n = 1, 100%) | Antibiotic therapy (n = 1, 100%) Poor response (n = 1, 100%) |
| Other reported adverse events (n = 21) | Not specified (n = 21, 100%) | Not specified (n = 21, 100%) |
Overall implant explanation: yes (n = 19, 38%), no (n = 8, 16%), not specified (n = 23, 46%).
Overall implant testing: yes (n = 2, 4%), no or not specified (n = 48, 96%).
Information on implant explantation before patient death and implant testing by manufacturers is presented as well.