Allergan and FDA approval

by Starz-10 11th April 2010, 8:04 pm

Does anyone know how many types of Allergan implants there are? Are the soft touch ones the same as Natrelle and Inspira? It's so confusing! And what exactly is FDA approval and what does it mean in terms of the implants?

by Starz-10 12th April 2010, 8:51 pm

Does anyone know where I can find out this info? I'm sure there's probably some details out there on the net somewhere but I just don't know where to look, help!

by Mistydinlv 12th April 2010, 9:01 pm

FDA approval means that they are held to the standards of the food and drug administration and if something where to go wrong with the product than the manufacturer can be held liable. There's alot of different Allergan implants. I have the Natrelle implants.

by BoobiePrize 12th April 2010, 9:26 pm

There's a good explanation of FDA approval here

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The only Allergan range that is FDA approved is the Natrelle, previously Inspira souft touch. They basically rebranded the range, I believe the anatomicals were also called something else, but Natrelle now incorporates the silicone round, anatomical and saline implants.

The ones that are not FDA approved is the CUI range, previously known as McGhan Style 410 implants. You can read more about it here

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HTH x

by BoobiePrize 12th April 2010, 10:25 pm

Other differences include

Allergan Natrelle
- lifetime guarantee (implants replaced in cases of CC or rupture and a nominal amount towards costs for a re-op)
- more ranges and sizes of implants (140 altogether)
-highly cohesive gel and biocell technology for textured implants

Allergan CUI
- 10 year warranty (implants replaced in cases of CC or rupture, no money paid towards re-op)
- only 5 ranges of implants, with limited sizes (12 altogether)
-made with cohesive gel

MicroCell Textured
Surface Designed
to Reduce Capsular

ContractureDRIE Barrier Shell
Technology for Reduced

Silicone Diffusion

Page 20 of the catalogue lists the style 410 (CUI) as an 'Investigational device' in the US not sure if that means its undergoing FDA approval...

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by Starz-10 13th April 2010, 12:43 pm

Thanks very much, that clears things up. So basically the best Allergans to get are the Natrelle ones if you want FDA approval. I wonder why they changed the name, makes things so confusing, lol!

Thanks x

by ***Sally*** 13th April 2010, 1:02 pm

I didn't know they'd changed the name. I have inspira soft touch although didn't really look into the different types of implant before I had my surgery so was none the wiser until afterwards!

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Allergan and FDA approval

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