Silicone Breast Implants – New Safer Silicone
Silicone is used in many of the products we use everyday. Often, the suntan lotion, creams and gels we use contain silicone. Because of its versatility, it can be made into many useful products. It is ideal for use in medical devices which are implantable and non-implantable. It can be molded into various shapes, sizes and contours, is durable and easily sterilized which makes it ideal for for use with implants, artificial joints and drainage systems and other medical devices.
What makes today’s silicone a safe option?
In 1992, the FDA called for a voluntary moratorium (delay) on the use of silicone breast implants until new safety information could be thoroughly reviewed by the FDA’s advisory panel. That same year, the FDA lifted this moratorium and announced its decision to allow access to silicone breast implants for reconstruction patients under controlled clinical studies, called Adjunct Studies. In 1999, the FDA allowed the use of silicone breast implants in Core Clinical Study’s to assess the safety and effectiveness of these devices.
While these studies are collecting information, the National Institute of Health’s Institute of Medicine (IOM) released a landmark 400-page report entitled “Safety of Silicone Breast Implants.” This 1999 report on the safety of silicone concluded “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.”
Thousands of studies were conducted and after thoroughly investigating the studies, the FDA could not find a link between silicone implants and an increased chance of disease. Therefore, silicone implants were re-approved in 2006. They are now approved for all women for breast reconstruction and for women aged 22 and older for breast augmentation.
The unique qualities of today’s silicone breast implants help make it the filler of choice for patients in countries where both saline-filled and silicone breast implants are widely available.
Silicone is a safe option for women wanting breast augmentation surgery. Unlike saline implants, if a silicone implant ruptures, it will keep its shape since the gel filler stays intact. This means that the implant will keep its shape and has less of a chance of appearing disproportionate as would a saline-filled implant. However, it is possible that the implant could rupture without being noticed and that some of the gel could leak into surrounding tissue. This is known as a silent rupture. Therefore, women who have silicone implants are encouraged to have MRI’s every three years to ensure there isn’t any foreign material from a ruptured implant. Because of their durability, it is rare that a silicone implant will rupture.