To understand the complications of silicone injection to the butt for augmentation we need to understand the history of silicone injection in the breast.
Dow Coming Corporation created the first medical grade silicone in the early 1960’s. There were three early silicone products: Dow Corning 200 fluid, Dow Corning 360 Medical Fluids and Dow Corning MDX 4-4011. The misuse of silicone is clearly documented in the docks of Yokohama Japan were the Dow Corning 200 was being stolen and injected into prostitutes who wanted to have bigger breasts to cater United States Service men who prefer women with larger breasts than the Asians. This product was never intended for use for industrial purposes. Subsequently, Dow Corning 200 was purified and became known as Dow Corning 360 with a higher purity but not design for injection. This product was branded as Dermagen and for the purpose of a dressing for burn patients. This product became used by physicians in Las Vegas for breast augmentation and subsequently because of severe complications the State of Nevada declares the injection of silicone a felony and ban silicone injection.
Significant complications started to resurface causing the FDA to investigate this product as a new drug. It is at this point in 1965 that Dow Corning under FDA issue a “notice of claim investigational exception for a new drugs no 2702”. The product for these studies was named Dow Corning MDX 4-4011. It was basically a higher purified Dow Corning 360. Years later, due to problems with the studies protocols the company elected not to pursue a formal premarket approval application.
By the 1990, thousands of patients have received facial and body injection of silicone to the point that FDA forbid the sell of liquid silicone for aesthetics purposes until standardized studies can verify the safeness of the product. To this date there is no long term study published in the literature under FDA guidelines. Remember this was early 1990’s and it was not until 1994 that the first medical liquid silicone was approved by the FDA. Not good at all. Certainly it has not approved the silicone for cosmetic indications to this date. Regardless of the warning silicone in the decade of the 1990’s was easily accessible in clinics and the problems continue. If you want to know what were the common problems read the next blog.