An introduction to medical grade silicone
Silicone is a wonder material with many industrial and medical applications. It is used in hip replacements, catheters, implants, syringes, respiratory masks, pumps, ultrasound equipment, and in scar treatments. Its qualities also make it suited for use in condoms, sex toys and breast implants.
While silicone is generally exceptionally safe and non-toxic, for medical and cosmetic uses it is important that it is free of siloxanes that have been linked to allergic reactions in some people. Medical grade silicone is usually manufactured using acetic acid to replace the chlorine atoms present in the more usual polydimethyldichlorosilane (PDMS) method.
In 2012, a French manufacturer was caught deliberately substituting industrial grade silicone in breast implants and other medical products; the silicone used was intended for stuffing mattresses! This scandal prompted the EU to thoroughly review all the regulations on medical products and other applications of silicone.
This six-year bureaucratic process is estimated to have cost EU taxpayers €17bn. Part of the reason for this marathon is that the toxicological risks alleged of silicone are still controversial. At the emotive heart of the debate are women given poor-quality breast implants that later leaked, causing a range of complaints; however, it has been shown that the siloxanes blamed for the symptoms are commonly present in the bodies of women without breast implants due to their presence in domestic products such as cosmetics. Even pure siloxanes have been shown to be non-toxic and non-irritant in laboratory and field studies.
Nevertheless, tighter regulations and oversight are now in place. These are technically referred to as Regulation 2017/745.
Consumers with silicone hoses in their family car are unlikely to be concerned about the new regulations; however, some buyers will need to ask their suppliers whether their products are compliant with the various grades and regulations established in the revised legislation. Many categories of product that were not previously subject to regulation are now included. A well-established silicone hose manufacturer, such as Goodflex Rubber, will be able to explain the grade of silicone your application requires and explain how any legislation applies to you, if at all.
Stronger regulation will not impede the medical and cosmetic take-up of silicone, as it is enabling products to be prototyped and developed cheaper, faster and safer than ever before.