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By admin, June 18, 2009 3:04 pm

Platinum is a metal used in the manufacture of the shell and gel components of silicone breast implants. FDA fully evaluated the scientific literature on platinum. Based on the existing literature, FDA believes that the platinum contained in the implant shell and gel is in the zero oxidation state, which poses the lowest health risk. This is further supported by the available biocompatibility testing, gel bleed testing, and clinical data on these implants.

Source: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm063719.htm#1

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By admin, May 15, 2009 12:11 pm

There are several ongoing clinical studies (i.e., investigational device exemption (IDE) applications) of saline and silicone gel-filled breast implants. These studies include those for the more cohesive silicone gel-filled breast implants manufactured by Mentor and Allergan (formerly Inamed), as well as studies conducted by other manufacturers. These devices are still in research and have not been approved for marketing.

In addition, Mentor and Allergan will are conduct studies on patients who get silicone gel-filled breast implants after they are approved.

Source: U.S. Department of Health and Human Services