Silicones are a family of chemical compounds. They are made from silicon, a naturally occurring element found in sand, quartz and rock. Next to oxygen, silicon is the most common element in the earth’s crust and becomes silicone when it is combined with oxygen, carbon and hydrogen. Depending on the arrangement of the molecules, silicones can be manufactured in a variety of forms including oils, gels and solids.
Silicones have been part of the consumer industry for over 50 years. Because they can be manufactured in various ways, silicones appear in a wide variety of products that most of us use everyday. Hairsprays, suntan lotions and moisturizing creams are just some of the consumer products that contain one form of silicone called dimethicone. Medical devices utilizing silicone include artificial joints, catheters, drainage systems, facial implants, tissue expanders and breast implants. Silicone products have been shown to be biocompatible, reliable, flexible and easy to sterilize, making them an ideal choice for both implantable and non-implantable medical devices.
In 2006, Health Canada approved Natrelle™ Silicone-Filled Breast Implants for breast augmentation and breast reconstruction surgery. The approval is based on preclinical testing, four years of data for 715 women from Allergan’s Core Clinical Study, three years of data from Allergan’s Natrelle 410 Study and a European rupture prevalence study. It’s important to note that silicone gel-filled breast Implants were never banned, rather, Health Canada called for a voluntary moratorium (delay) on the use of silicone gel-filled breast Implants until new safety information could be thoroughly reviewed by an advisory panel. Over the past several decades, silicone technology has improved to where today’s Implants are made with more consistent manufacturing parameters.
The safety of Natrelle™ Silicone-Filled Breast Implants is supported by extensive U.S. clinical studies, a European study, worldwide experience and peer-reviewed literature, and 30 years of real-world experience in more than 60 countries. The Institute of Medicine (IOM) concluded in their 1999 report on the safety of silicone that "There is insufficient evidence to support an association of silicone breast Implants with defined connective tissue disease.” The IOM also stated “There is no convincing evidence for atypical connective tissue disease or rheumatic disease or a novel constellation of signs and symptoms in women with silicone breast Implants." For more information, please read the IOM report which contains the history of breast Implants and studies concerning their safety.
The unique qualities of today’s silicone gel-filled breast Implants help make it the filler of choice for patients in countries where both saline-filled and silicone gel-filled breast Implants are widely available. Learn more about the safety of silicone.
Allergan has a global reputation of providing safe, effective and high quality breast options for over 25 years. Now, Health Canada has evaluated and determined that the silicone breast implants in the Natrelle™ Collection are safe for use in breast augmentation and reconstruction surgery. Additionally, the range of breast implants in the Natrelle™ Collection gives surgeons the flexibility to improve your breast implant experience and outcome. Do the research and then consult with your Natrelle™ experienced surgeon about the complete line of Natrelle implants that can provide the right fit.
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The information presented is intended for Canadians only. If you are a U.S. resident please visit www.natrelle.com
This website last modified 06/09/06.