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.