New Type Of Silicone Gel For Breast Implant Gets Approved By DFA

Here’s another good news, new silicone-gel breast implant have been marked passed by the US DFA. Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Gel Filled Implants from Allergan Inc. are now officially usable for breast augmentation beginning 20th of February this year. However it can only be used for women aging 22 and above. But for breast reconstruction purposes, it’s suited for any age. You can check this out for more.

The Natrelle 410 implant, according to the maker has more cross-linking as compared to their previous Natrelle models that’s why it’s firmer. The approval wasn’t easy though as it was based on a seven year worth of data from about 900 women. Most of the complications and results were the same as the ones who were found on previous breast implant studies like tightening of the area around the implant, reoperation, removal and uneven appearance and infection.

Silicone-gel implants really had a rocky history. For 2 decades, the FDA always questioned its safety. In 1992, the agency actually made restrictions to the access of gel implants after research and evaluation. In 2006, the agency allowed the silicone gel implants back in the market after having a strict and well regulated research which ruled out all the concerns regarding disease. But with the new Natrelle 410, together with other approved silicone gel implants, FDA required the manufacturers to do some rigorous post-approval studies to make some assessments with its long-term safety, effectiveness, outcomes and the risks of certain rare diseases.

And so, for the next 5 years, Allergan will follow the cases of about 3, 000 women who have received Natrelle 410 implants. Together with it, they will also do a 10 year period study for 2, 000 women receiving the same implants to gather information on its long term local complications and some less common side effects. And lastly, the implant manufacturer is said to make an analysis of the Natrelle 410 implants that were removed from the patients and returned to them.

Breast augmentation is such a growing trend among women these days. A lot of huge institutions and most of them highly respectable ones say that there has been a great increase on cases of breast augmentations and other methods regarding breast. Since is the reality among people these days, it’s recommended that people should go to the right plastic surgeons. This is to ensure safety and success among patients. Click here to get more information regarding such.