Study carried out by the North-American Institute of Medicine determines the safety of silicone mammary implants

According to the result of the research, there is no conclusive evidence of possible damage to the health of women who use mammary implants.

North-American doctors from the Institute of Medicine of the United States National Academy of Sciences undertook extensive research on the safety of silicone mammary implants and their possible relation to diseases and contamination by metals. The studies were developed at the request of the U.S. Department of Health and Human Services (DHHS). A significant group of women – and in some cases the children of these women – was analyzed in order to present all the conclusions of the study.

Among the first premises of the research is the constant contact of the public – especially in developed countries – with silicone, already present in foodstuffs, cosmetics, machine lubricants and hypodermic syringes, among other products. Silicone has been used as a mammary implant since 1962, and throughout these years implants, their shape, coating and even the composition of their gel have undergone improvements.

According to the Institute of Medicine, in 1997 it was estimated that between 1.5 and 1.8 million North-American women had silicone mammary implants. Of this total, 70% opted for implants for aesthetic reasons, and 30% underwent reparatory surgery. The medical committee also found that over 10 million Americans had some kind of implant, most of them made of silicone.

The study of the Institute of Medicine analyzed research already carried out on the use of silicone implants (studies on the toxicology of silicone were begun in 1940), studies on the development of antibodies against silicone, the most frequent complications in implanted women (such as cases of rupture and capsular contracture), patients with implants who developed some form of cancer, and children breast-fed by women with implants.

The committee of doctors responsible for the survey indicated after months of analysis that the studies on the toxicology of silicone and other substances existing in mammary implants did not present rates harmful to health. There is no conclusive proof that the occurrence of rheumatic diseases or the incidence of cancer among women with implants is caused by the implants, and these diseases are liable to occur with the same incidence among women without implants.

Analysis of the maternal milk of women with implants also failed to show any excessive presence of silicone or any other foreign substance. Based on this conclusion, doctors stress that implanted women can – and should – breast-feed their children normally without there being the least risk to their health.

A recent survey

With regard to the study presented by American University chemist S.V.M. Maharaj on the high concentration of platinum in the organism of a small group of women who underwent silicone mammary implantation, Silimed clarifies that:

-The medical-grade silicone used to manufacture its implants is produced by Applied, an American company with considerable credibility in the market.

- The biocompatibility studies carried out by Silimed proved that the amount of platinum found in the silicone implants manufactured by the company corresponds to between 5 and 10 ppm (parts per million), rates considered to be non-toxic by the Washington Institute of Medicine, which undertook a broad survey on silicone in response to a consultation made by the American Congress on possible damage caused by the product.

- This same research found that children breast-fed by mothers with silicone mammary implants suffer no damaging complication as a result of this. Silicone has been used for 40 years in plastic surgery (aesthetic and reparatory) and until now there has been no evidence of any possible generation of babies presenting visual, auditory or any other kind of deficiency due to their mothers’ silicone implants.

- The company, whose participation in the American market is still small, has not been notified up to the present moment in time of the appearance of any case of high concentration of platinum in American women who have used SILIMED implants.