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Methods:

A systematic search of the Manufacturer and User Facility Device Experience (MAUDE) database was performed to identify all cases of breast implant-associated deaths reported to the FDA.

Results:

The search identified 50 reported cases of apparent implant-related mortality; breast implant-associated anaplastic large cell lymphoma comprised the majority of fatal outcomes (n= 21, 42%), followed by lymphoma (n= 4, 8%), breast cancer (n= 3, 6%), pancreatic cancer (n= 2, 4%), implant rupture (n= 2, 4%), and postoperative infections (n= 2, 4%). Single cases (n= 1, 2% each) of leukemia, small bowel cancer, lung disease, pneumonia, autoimmune and joint disease, amyotrophic lateral sclerosis, liver failure, and sudden death, and 2 cases (4%) of newborn deaths, to mothers with breast implants, were also identified. A literature review demonstrated that 54% of alleged implant-related deaths were not truly …