Table 3.
Overview of the Reported Causes of Mortality Associated with Silicone and Saline Breast Implants; Causes Are Classified According to Whether an Evidence-based Association Exists in the Literature Linking Them to Breast Implant Use
| Fatal Outcomes | n | Source of Reports | |||
|---|---|---|---|---|---|
| Silicone | Saline | Total | Health-care Professionals and Journal Publications | Other* | |
| Implant association supported by the literature | 23 | 20 (87%) | 3 (13%) | ||
| BIA-ALCL | 11 | 10 | 21 | 20 | 1 |
| Postoperative infection leading to sepsis | 1 | 1 | 2 | – | 2 |
| Implant association unsupported by the literature | 22 | 4 (18%) | 18 (82%) | ||
| Malignancies | |||||
| Lymphomas of unspecified origin | 1 | 2 | 3 | – | 3 |
| Breast cancer | 1 | 1 | 2 | 1 | 1 |
| Burkitt’s lymphoma | – | 1 | 1 | – | 1 |
| Leukemia | 1 | – | 1 | – | 1 |
| Small bowel cancer | 1 | – | 1 | – | 1 |
| Pancreatic cancer | 1 | – | 1 | – | 1 |
| De novo pancreatic cancer in BIA-ALCL patient | 1 | – | 1 | 1 | – |
| Other | |||||
| Newborn death | 2 | – | 2 | – | 2 |
| Sudden death | 1 | – | 1 | – | 1 |
| Pneumonia | – | 1 | 1 | – | 1 |
| Pulmonary fibrosis | 1 | – | 1 | – | 1 |
| Lupus, fibromyalgia, and lung disease leading to respiratory failure | – | 1 | 1 | – | 1 |
| Autoimmune and joint disease | 1 | – | 1 | – | 1 |
| Amyotrophic lateral sclerosis | 1 | – | 1 | – | 1 |
| Liver failure | 1 | – | 1 | – | 1 |
| Implant rupture and capsular contracture | 1 | – | 1 | 1 | – |
| Implant rupture, silicone leak, systemic migration, and breast cancer | 1 | – | 1 | 1 | – |
| Implant rupture, suspected silicone leak, and infection | 1 | – | 1 | – | 1 |
| Cause of death unspecified | 5 | – | 5 | 2 (40%) | 3 (60%) |
Reporting sources provided.
*Other sources include patients, patient families, and friends, third-party clinical research organizations, “company representatives,” and media reports.