How Is Medical Silicone Made? | Biodermis

How Is Medical Silicone Made? |

Medical silicone is an ingredient found in many different products these days, from breast implants and shampoos to silicone gel products for scars. The reason silicone is widely used is because of its biocompatibility, which gives it the ability to interact safely with the human body. This is because silicone is non-toxic, durable, and non-reactive. But where does it come from and how is it made? In this article, we will explore these topics so that you have a better idea of what is inside the products that you use every day.  

Before we arrive at medical grade silicone, we must understand that there are many steps in the process leading up to it. Silicone comes from silicon, which is an element (number 14) on the periodic table of elements. Silicon is the second most abundant element on earth and makes up more than 25% of the earth’s crust. Silicon can be found in nature as silicon dioxide, one of the main elements of quartz. Silicon is a hard, brittle metalloid with a bluish-metal luster and crystalline structure. As a metalloid, it contains properties exhibited by metals and nonmetals. By itself, silicon isn’t a reactive substance, meaning it’s harmless and combines well with other elements.

When silicon is turned into silicone, it is known scientifically as polysiloxane. Silicone is a synthetic compound created when silicon atoms link to oxygen to form a chain of repeating silicon and oxygen atoms. Sometimes this bond is combined with hydrogen and carbon to create silicones with different properties. Silicone is known for its low toxicity, resistance to heat and chemicals, insulation, and ability to repel water. The practical applications of silicone are endless, and its widespread use can be seen in the automotive, aerospace, cooking, electronics, cosmetics, and medical industries. When it comes to medical grade silicone, this means that it is safe for medical purposes and for the human body.

So what exactly makes medical-grade silicone classified as medical-grade? This has to do with the FDA’s standards for what is safe and effective in medical care and treatment. Medical-grade silicone for scars, for instance, is backed by more than 30 years of clinical evidence and is cleared by the FDA to be worn safely on the body for long periods of time. Medical-grade silicone is also hypoallergenic, latex-free, and contains no toxins or chemicals. Given that silicone is a stable and non-reactive ingredient, silicone products usually don’t expire. Therefore, if you are holding onto silicone gel sheets for scars, they can be stored safely without the product losing any of its effectiveness. In essence, then, medical-grade silicone has come a long way from being a simple element in the earth’s crust.    


Biodermis is an innovative market leader with 30 years of expertise in the medical silicone industry. Visit today to explore a complete range of scar management and post-operative care solutions.


Biodermis offers custom tailored referral programs designed to simplify and reduce the cost of your patients' post-op care. Additionally, we offer professional pricing if you opt to retail our products. Give us a call at 800.322.3729, and we will be happy to provide additional details on these programs.