Silicone-Filled Breast Implants

The purpose of this article is to provide answers to some of your questions about silicones and breast implants, and to provide an overview of silicones, their common uses, and why they are chosen by medical professionals. As with any medical device or drug, the risk of possible adverse effects must always be weighed against the ability to provide benefits. If you have any questions, please be sure to ask your physician. Please note, this article is not meant to supplement or replace product labeling or medical advice regarding risks and benefits associated with implantable devices.
*Caution: Silicone Filled breast implants are limited distribution devices and are only available by or on the order of a licensed physician as part of an Allergan/McGhan Medical Clinical Study.

What is Silicone?

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.

Consumer and Medical Products

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. The applications of silicone, whether used as an oil, gel, or solid, are equally extensive in the medical field. For example, the lubricating qualities of silicones make them ideal for coating surgical needles and suture thread, as well as the inside of syringes and bottles used for the storage of blood and intravenous medicines. Protective silicone coatings have also been used in pacemakers and heart valves. Other medical devices utilizing silicones 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 nonimplantable medical devices.

Safety Issues

Safety issues concerning the use of silicone in medical devices have primarily focused on the possible link between breast implants (both saline-filled and gel-filled) and certain illnesses, including breast cancer and connective tissue disorders (also referred to as autoimmune diseases such as lupus, scleroderma, and rheumatoid arthritis). Silicone materials have been tested extensively in laboratory studies, as well as clinical studies (those that study human health). Of the one to two million women who have received breast implants, much scientific evidence has already been gathered. The following is a summary of current published scientific information concerning silicone breast implants, breast cancer, and connective tissue disorders (CTDs).