Medical Grade Silicone

Often mistaken for plastic or rubber, medical-grade silicone is a safer option for use on and inside the body. As well as being hypoallergenic, non-reactive, and bio-compatible, it is also more eco-friendly for the environment.

Frequently used to produce healthcare products like kegel weights, menstrual cups, pelvic wands, and vaginal dilators, medical-grade silicone is also used to make baby bottle nipples, scuba gear mouthpieces, and dental products. 

Read on to understand why medical-grade silicone is superior, safer, and more long-lasting than other materials like conventional silicone, or plastic. 

We’ll also explain how to differentiate between high-quality, FDA-approved, medical-grade silicone and silicones of lesser quality.   

What Is Silicone? 

Silicone is an elastomer, which means it is a rubber-like material that can readjust to its original shape after being stretched. It is primarily made from silicon dioxide (containing silicon & silica), which is one of the most abundant natural minerals on earth and is plentifully found in sand. 

What Is the Difference Between Silicon and Silicone? 

Despite the similarities in spelling, silicon & silicone are quite different. Silicon is a hard and brittle chemical element abundantly found in sand and used to make products like computer chips, glass, ceramics, transistors, semiconductors, and silicone. 

Silicone, on the other hand, is a soft and flexible man-made material that is produced by combining silicon with oxygen, hydrogen, or carbon.  

How Is Silicone Made?

Although made with a natural mineral from sand, a chemical process is required to make silicone. Simply put, this process involves heating sand to extreme temperatures to separate the silicon from silica. Once cooled, the remaining silicon is ground into powder. Further heating and distilling processes are used to add hydrogen, oxygen, or carbon, and the silicone is then cured, or dried.  

After this process, conventional silicone is typically soft, flexible, heat-resistant, and water-resistant.  

What Is the Difference Between Silicone and Medical-Grade Silicone? 

The main difference between conventional silicone and medical-grade silicone is how the silicone is cured, which essentially means dried. A Peroxide Curing System is typically used for conventional silicone, and although the peroxides and their radicals are dispersed during the process, an acidic byproduct is also produced.

This byproduct renders conventional silicones non-biocompatible, meaning they can be harmful or toxic to the body. 

When producing medical-grade silicone, however, the Addition Cure or Platinum Cure System is used. In this process, a catalyst in the form of platinum salts is used to cure the silicone and no reactive byproducts are produced.

Although this more expensive process means medical-grade silicone is more costly than conventional silicone, it also means it is safer for the body. 

After the Addition Cure or Platinum Cure System, medical-grade silicone is non-reactive, biocompatible, and hypoallergenic, in addition to being soft, flexible, heat-resistant, and water-resistant.  

How To Know If Something Is Pure Medical-Grade Silicone? 

Even though medical-grade silicone products are required to pass reactivity and toxicity testing by the FDA, many producers sell to consumers without FDA registration or approval. Unfortunately, this means that many products claiming to be made from medical-grade silicone contain fillers that are not bio-compatible and could be toxic to the body. 

To check if your vaginal dilator, pelvic wand, menstrual cup, or kegel weights are made from medical-grade silicone, stretch the material and watch the color. If the material goes white when stretched, it contains filler, is not biocompatible, and could be harmful to the vaginal microbiome. 

Currently, Intimate Rose is the only producer of medical-grade silicone kegel weights, pelvic wands, and vaginal dilators on the market that have been FDA-registered and approved.

Why Silicone is More Eco-Friendly Than Plastic

Plastic dilators typically contain petroleum or oil and phthalates to extend the life of the product. And as the plastic begins to deteriorate over time, phthalate toxins and harmful microplastics are released back into the environment where they cause environmental pollution as well as ongoing health issues when inhaled or consumed by humans. 

In contrast, silicon dioxide, from which medical-grade silicone is made, does not contain or release any toxins that are harmful to the environment or the human body. Even though it is an incredibly long-lasting material, only carbon dioxide, silicon, and water are released back into the environment when silicone products eventually break down. 

Essentially, when it comes to dilators, kegel weights, pelvic wands, or anything else that is inserted inside the body, medical-grade silicone products that are FDA-registered and approved, like those from Intimate Rose, are the safest option for both you and the planet. 

Conclusion

Medical-grade silicone is a toxin-free, hypoallergenic material that is made using one of the most plentiful minerals on earth – silica. Considered safe for use against the skin as well as inside the body, it feels soft and flexible yet firm enough to hold its shape.

Frequently used to make an array of products since the 1930s, medical-grade silicone is now considered the safest material for medical devices like vaginal dilators, Kegel weights, and pelvic wands.   

Due to the chemical process required to make medical-grade silicone, it is not considered an organic product, but because the main components are harmless and naturally derived from the earth, medical-grade silicone is considered a much safer material than plastic, rubber, or conventional silicone. 

References

Science Direct – Elastomer - https://www.sciencedirect.com/topics/chemistry/elastomer

Medical Advice Network – Is Medical Grade Silicone the Most Versatile Material in Med Tech? - https://www.medicaldevice-network.com/sponsored/is-medical-grade-silicone-the-most-versatile-material-in-med-tech/

Simtec - Liquid Silicone Rubber for Medical Applications - https://www.simtec-silicone.com/blogs/liquid-silicone-rubber-for-medical-applications/