Bradford Hill and breast implant illness: no evidence for causal association with breast implants

Abstract

Breast Implant Illness is a controversial entity that describes a constellation of symptoms reported by a small part of women with silicone breast implants. To date, there is no evidence-based definition of the condition, neither are there convincing studies that show a causal association between silicone breast implants and breast implant illness or autoimmune disease. Cohen Tervaert et al. argue that the existence of this causal association can be scientifically proven by application of the Bradford Hill criteria. However, their study of the literature is hampered by selection of reports that support their claims and absence of research that contradicts them. Moreover, the authors occasionally misrepresent conclusions of the studies they refer to. Furthermore, selected studies were not evaluated in terms of their methodological quality. Silicone breast implants contribute significantly to the quality of life of many breast cancer patients and women with cosmetic implants. Any potential adverse effect of silicone breast implants must therefore be carefully weighed against the benefits of silicone breast implant-based procedures. In this consideration, evidence based on studies with a sound methodology is of vital importance.