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FDA BREAST IMPLANTS

 

FDA health advisors have recommended removal of the thirteen year old ban on silicone gel breast implants and this happened after Mentor persuaded FDA that it's silicone implants are durable and safer as compared to older versions. These implants could only be used under the safety conditions set by FDA.

As per Dr. Daniel G. Schultz, director of the F.D.A.’s Center for Devices and Radiological Health stated that company sponsored studies on silicone implants along with long term use of implants around the world was enough to approve the use of implants in the best interest of American women.

 

Mentor will be employing the implants under the strict safety conditions approved by the FDA. The prospective patients need to sign a consent form acknowledging that they realize the risks of a silicone breast implant which include the fact that they could break and need replacement or removal. As per FDA, Mentor must maintain and produce a registry for tracking the implants. Also FDA would be required to conduct ten year study for determining the % of breast implants which will break in that time.