4th Silicone Breast Implant approved by FDA
FDA has approved another silicone-gel based breast implant. Only the fourth ever approved silicone-gel breast implants. This new implant is from Allergan Inc. - a multi-specialty health company specializing in the production of innovative biologically safe medical products.
Allergan Inc. hails this new implant as “Natrelle 410”. Natrelle 410 is engineered to accurately mimic natural womens' breast shape and curves, though it is recommended by the manufacturers that Natrelle 410 is more ideal for women 22 years of age and above.
Natrelle 410 can also be used as a re-constructive implant for those who had their breast/s removed due to cancer or trauma.
According to FDA, breast implants should first pass a very delicate probation test before it can legally penetrate the Market. The test also requires the manufacturers to do a dedicated study about the risks and long-term safety associated with breast implants.
The approval of Natrelle 410 is from Allergan's 7-year research and data monitoring from more than 900 subjects. FDA has qualified Natrelle 410 as one of the safest silicone-gel breast implant available in the United States and International regulations.
Natrelle 410 assets:
-uses a cohesive filler that stays in place
-no gel migration
-less than 1% chance of wrinkling overtime
-soft to touch
Although there are already FDA approved implants, women should still be wary about the risks with having implants. Implants are still prone to occasional adversities such as malpositioning and rupture.
According to Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health,“It’s important to remember that breast implants are not lifetime devices,". "Women should fully understand the risks associated with breast implants before considering augmentation or reconstruction surgery, and they should recognize that long-term monitoring is essential.”