Numerous case reports in the 1980s appeared to suggest a linkage between silicone gel implants and connective tissue diseases and symptoms. The principal connective tissue disorders included scleroderma, rheumatoid arthritis, systemic lupus erythematosus, Sjogren syndrome, dermatomyositis, polymyositis, and polymyalgia rheumatica. There was also a concern over the possibility that the implants were linked to breast cancer and problems in breast-fed newborns. In response to this, the US-FDA in 1992 issued a moratorium on silicone breast implants and restricts the use of the implants for breast reconstruction and clinical studies only.

Subsequently, a number of large, population-based retrospective studies were conducted to test the association between silicone breast implants and connective tissue disorders. All studies have concluded that there is no association between silicone breast implants and any connective tissue disease. In addition, since the moratorium on silicone breast implants, several studies have proved that these devices are safe and do not cause connective tissue disease, malignancy, or risk to breast-feeding infants. Furthermore, clinical studies conducted by the British Department of Health and the Institute of Medicine of the National Academy of Sciences both demonstrate that silicone breast implants are safe for pregnancy, lactation, and breast-feeding.

In 1999, a landmark report, undertaken by the Institute of Medicine (IOM) concluded that silicone implants do not cause major health problems such lupus or rheumatoid arthritis. And while no one can ignore the fact that silicone - and saline - breast implants may cause localized problems for some patients, numerous scientific studies over the years have shown that silicone gel-filled implants are both safe and effective for breast augmentation and reconstruction. In fact, silicone gel breast implants are widely used in 60 countries around the world including Europe, and now are available for use in the U.S. market.

The U.S. Food & Drug Administration (FDA) announced November 17, 2006 the approval and availability of silicone gel-filled breast implants, ending a 14-year ban on the use of silicone implants for cosmetic breast surgery. Now all women over 22 years old seeking cosmetic breast augmentation and women seeking breast reconstruction surgery will be able to select silicone breast implants. The availability of silicone gel implants will create new options for women considering breast surgery for the first time and for those who have had previous surgeries but are seeking new replacements or revision.

Silicone breast implants offer several advantages over saline implants. They also have some disadvantages, so you and your surgeon should carefully weigh the pros and cons, if you are considering this option.

The major benefits of silicone breast implants are in the realm of a more natural look and feel. These implants are filled with silicone gel, which is softer and more natural (in the way it feels to the touch) than saline breast implants. They feel so soft and natural, that it is often impossible to discern them from natural breast tissue.

Rippling is far less likely to occur in women with silicone implants than in women with saline implants. This is because silicone gel is far more viscous (thicker) than saline, so it does not move or slosh, as saline can. Silicone implants can be placed over the muscle in women with little body fat or little breast tissue without the aesthetic concerns (rippling) associated with placing saline implants over the muscle in these women.