[SILICONE BREAST IMPLANTS - HISTORICAL MEDICAL ERROR].

ABSTRACT

INTRODUCTION: Silicone is a foreign material to our body and therefore, has been found to stimulate the immune system. Silicone breast implants (SBIs), made of silicone polymer, have been used for aesthetic and medical purposes since the 1960s, and were found to trigger acute/chronic inflammation, eventually leading to the formation of fibrotic capsules on the surface of the implant. Silicone implants have been found to be associated with the development of severe and sometimes unexplained clinical manifestations such as chronic fatigue, sleep and memory problems, widespread pain, dry mouth and eye, depression, arthralgia, myalgia, palpitations, tinnitus and hearing loss, skin rash, hair loss, vision problems, hyperhidrosis, allergic reactions, etc. Furthermore, SBIs have been found to be associated with the development of rheumatologic/autoimmune diseases and the development of rare lymphoma. The FDA has expressed concern over the years about the implications of SBIs and requested that the companies involved provide data of any concern regarding the implants. However, the companies continued to sell the implants without reporting data, as agreed. In October 2019, the FDA recommended boxed warnings describing the dangers facing women applying for SBIs such as lymphoma. Importantly, our lab recently found the presence of autoantibodies against the autonomic nervous system in the blood of women with SBIs, which might explain some of the patients' severe symptoms. Owing to the numerous data that had been accumulated (since 1960s) indicating a direct link between silicone, autoimmune diseases and cancer, we believe that the use of SBIs has been a historical medical error.