Unnecessary Regulations On Silicone Could Put Patients In Jeopardy

Thanks to its high performance in a variety of settings, silicone has found its way into thousands of medical devices, from the most mundane to the most sophisticated. You’ve probably never visited a hospital without touching silicone material of some kind. It’s used in medical tape, electronic covers, syringe coatings, IVs, catheters, bed cushions, breathing masks, ECG leads, CT machines and much more. The undisputable fact is that the use of silicones is leading to significantly better outcomes for patients.

But while it improves our lives in countless ways, some bureaucrats and activists, particularly in Europe, have used flawed scientific models to push for restricting and even banning the use of certain silicone compounds in consumer products. This comes despite the governments of Canada and Australia both having studied the effects of silicone materials and concluded that they present no risk to human health and have no significant environmental impact.

Silicone combines several chemical properties that make it uniquely suited for many health care applications. It’s extremely elastic, functions as an effective sealant, and has exceptional durability and biocompatibility — making it ideal for use in materials that come into direct contact with human tissue. The fact that silicone doesn’t react with other compounds and rarely provokes allergic reactions makes it an attractive candidate for use externally, internally, and intravenously. Its resistance to heat and radiation also makes it easy to clean or sterilize, reducing the risk of infection.

On the other hand, removing every silicone-containing object from our health care facilities would deprive them of life-saving equipment and would dramatically reduce the quality of care available to patients. Banning silicone will increase costs and cost lives.

Even though silicone’s medical applications date back to the 1940s, it continues to drive important innovation in health care. For example, researchers have experimented with silicone sheaths capable of monitoring organ functioning and addressing abnormalities without invasive surgeries. By embedding electrodes inside the sheaths, it may be possible to convey electrical signals to the heart as an alternative to pacemakers.

Silicones also play a central role in prosthetics. They can be fashioned to closely resemble the consistency and appearance of skin and are capable of cushioning shocks and absorbing vibrations better than alternative materials, increasing comfort and functionality. Similarly, silicones are used for breast augmentation, including the shells used for saline-filled implants.

For more than seven decades, silicone has played an increasingly prominent role in medical innovation in the United States, and exciting new possibilities are constantly being explored to broaden its applications still further.

Considering the benefits silicone offers, it’s troubling to see some regulators in the European Union trying to restrict its use without credible evidence of harm. While one of the sectors in which silicone has its widest applications and delivers the most benefits is in medical technology, the fact is that we interact with silicone dozens of times per day without even realizing it. If you’ve used personal care products, cooked a meal, or driven a car today, chances are you came into contact with a product that uses silicone.

The economic impact of silicone in the medical industry is substantial and growing rapidly. In the United States, 9,700 tons of silicone — with a combined value of $132 million — were used by the healthcare sector in 2013. Freedonia Group projects that demand for silicones in the medical market will rise at an annual rate of 5.9 percent in the coming years, reaching $363 million in 2022. According to the analysis, this growth will be predominantly driven by silicone’s exceptional biocompatibility and low toxicity compared to alternative materials like latex and polyvinyl chloride (PVC).

Given silicone’s enormous value in ensuring that Americans receive the best possible healthcare, impeding its use would be a mistake for our economy, our health care sector, and, most importantly, the patients who benefit from it every day.

Liam Sigaud writes for the American Consumer Institute, a nonprofit educational and research organization. For more information about the Institute, visit www.TheAmericanConsumer.Org