Death By Implants: A Critical Analysis Of The Fda-maude Database On Breast Implant-related Mortality
Jad Abi-Rafeh, MSc, MD, CM (c), Tyler Safran, MD, CM, Becher Alhalabi, MD, PhD, Tassos Dionisopoulos, MD, FACS, FRCSC.
McGill University, Montreal, QC, Canada.
PURPOSE: Since the 1996 moratorium by the FDA, the debate on the association of breast implants with systemic illnesses has been ongoing. Breast implant-associated anaplastic large cell lymphoma(BIA-ALCL) has also raised significant safety concerns in recent years.
METHODS: A systematic search of the U.S. Manufacturer and User Facility Device Experience (MAUDE) database was performed to identify and critically analyze all cases of breast-implant associated deaths reported to the FDA.
RESULTS: The search identified 50 reported cases of apparent implant-related mortality; BIA-ALCL 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, as well as 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 associated with breast implant use: the majority of these reports (82%) originated from the public and third-party sources, rather than evidence-based reports by healthcare professionals and journal articles.CONCLUSIONS: While there exists a need for more comprehensive reporting in federal databases, the information available should be considered for a more complete understanding of implant-associated adverse outcomes. With only 46% of FDA- reported implant-related deaths demonstrated to be truly associated with breast implant use, there exists a need for public awareness and education on breast implant safety.
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