Silicone Gel Breast Implants in Breast Augmentation – Scientific Assessment of their Safety
Despite the release of silicone gel breast implants for widespread commerical use in late 2006 and being one of the most (if not the most) studied medical device in history, some patients do question their safety. Any patient over 30 years of age has some recollection of the publicity surrounding the moratorium of silicone gel breast implants back in the early 1990s.
Understanding the science of silicone goes along way in addressing the safety of silicone gel implants for patients when used for both breast augmentation and in breast reconstruction.
First and foremost, silicon as an element is a naturally occurring material (check the Periodic Table) found in sand, quartz and in many types of rocks. It is one of the most common elements that we as humans come into contact with. (oxygen is the most common) When combined with oxygen, carbon, and hydrogen (all naturally occurring elements) in a manufactured process, the polymer silicone is borne. Secondly, silicone has great diversity as a manufactured product and can be made from a liquid form to a solid. It is part of thousands of manufactured products, many of them topical in form for human use. Many of the products used in the beauty industry contain silicone. More relevantly, the use of silicone in medical products is extensive from intravenous catheters to the coatings of joint replacements. As humans, we all have had sufficient exposure to silicone products that most every human alive will test positive for silicone levels.
While silicon is a element and we all have had lots of exposure to it, what does that mean when it is implanted internally in a high volume in one spot? (or in this case, two spots)
The historic conern about the safety of silicone gel breast implants revolves around their potential association with autoimmune diseases. Does a sufficient quantity of silicone, or a long duration of exposure, make the body think it is an immunogen and induce the possibility of autoimmune disease creation?After over 15 years of exhaustive clinical studies, no definitive link between any autoimmune disease (e.g., arthritis, lupus, scleroderma) has yet to be found. The initial link between silicone breast implants and women seemed obvious but the association has turned out to be coincidental as autoimmune diseases have a natural high predilection for women between the ages of 20 and 50, who also are the main recipients of breast implants. The occurrence of autoimmune diseases in women with breast implants is no higher than in women who do not have breast implants. In short, there is no scientific evidence that a silicone gel breast implant increases the risk of autoimmune disease…..or increases the risk of developing breast cancer.
Lastly, it would be hard to imagine that the FDA would re-introduce silicone gel breast implants, and all of the attendant medical-legal risk and liabilities, unless there was absolutely no current evidence of potential harmful effects. As a precaution, the commerical release of silicone gel breast implants comes with a mandate from the FDA…every implanted patient must be enrolled in the Post-Approval Study where further long-term data will be collected over the next ten years. This obligates every implanting plastic surgeon to enroll their patients in this monitored long-term study. The final statement on the safety of silicone gel breast implants will be written in another decade based on hundreds of thousands of implanted women.
Dr Barry Eppley
Indianapolis, Indiana