Allergan FDA Approved Implants

It's very confusing which implants are FDA-approved but I don't think the Inspira Soft Touch are. The responsive gel is currently FDA-approved (you need to check the specific styles which are approved) and the highly cohesive are in trials.

The Soft Touch was introduced in Europe because the round highly cohesive is too firm. Highly cohesive is better for anatomicals.

I've not had any consults yet but are people actually being told the SOft Touch is FDA-approved because as far as I can see this isn't true.

You should ask for proof that it is true - there's a list of the approved styles and if your style isn't in the list it isn't approved - it's as simple as that.

The US range is called Natrelle and there's no mention of different gels on the US website because there is only 1 type approved and that's responsive.

However, the Soft Touch is more cohesive so is probably better even if it isn't FDA-approved. It's just misleading to say it is.

Yes the Responsive are and Soft touch arent yet, but most probably will be soon its been said, it was the guarantee that swung me rather than the FDA approval though

I don't think the Soft Touch is being trialed so it won't be FDA-approved. Only the gummies are being trialed as far as I can see.

Can you provide a link?

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I was just wondering where the information that Soft Touch is FDA-approved is coming from - is it forum myth or is this what people are being told at their consults?

As I said I haven't been on a consult yet. I'm still saving up.

I mean a official website/link, thats a surgeon's website and It doesnt say in that link that the implants aren't being trialed i dont think, or i missed it.
I wasnt told about implants being FDA approved at my consults, i researched mine and thought they were the best for me and the lifetime guarantee suited me

It is the Inspira Responsive ones that are FDA Approved but the Soft Touch are in available to women on the US who are willing to have their progress monitored for the next ten years. The soft touch are more cohesive than the responsive ones so it is expected that they will be the new generation of FDA Approved implants. Hope this is of some help x I opted for the Soft Touch and am very happy with them.

mrs o wrote:The soft touch are more cohesive than the responsive ones so it is expected that they will be the new generation of FDA Approved implants.

Exactly, if they are more cohesive than implants that are currently approved then im sure they will be after the trials

mrs o wrote:It is the Inspira Responsive ones that are FDA Approved but the Soft Touch are in available to women on the US who are willing to have their progress monitored for the next ten years. The soft touch are more cohesive than the responsive ones so it is expected that they will be the new generation of FDA Approved implants. Hope this is of some help x I opted for the Soft Touch and am very happy with them.

Can you provide a link that states this, even if it is only from the website of a surgeon conducting the trials.

The Soft Touch are more cohesive than the responsive but are less cohesive than the highly cohesive implants being trialed.

You still havent provided a link miah that says they arent being trialled.
This post has gone a little off topic so can we stick to the original poster's question, who wants to know which one to go for, thanks

I read it somewhere on the net and my surgeon confirmed it for me. I had the option of the responsive ones, but decided on the more cohesive ones as my personal opinion is that they will replace the responsive ones, but this is my opinion only. Why not try googling silicone implant trials in the us? Good luck with your decision x

CLAIRE3567 wrote:Hi girls,

need your views

Have option of going 260cc allergan or 240cc inspira soft touch.

I know the Inspira range are FDA approved and have 15 yr guarantee- but are £400 more.

so confused as to which to go for!!!!

Not sure why I'm off-topic as I was just interested to know if anyone can in fact prove the statement that the Inspiras are FDA-approved. Or even in clinical trials in the US.

But it doesn't matter if nobody here but me is interested. :lol: I'm not trying to start a fight.

The FDA site doesnt seem to have been updated since 2006 so its hard to find out, if i find out anything i will post it here

Snake has commented on this in detail in his Snippet: Types of Implants (mar 4) - quite a long thread

I am intersted! I think if you have a look at snakes website and do some research yourself you will find, as i did, that the soft touch are not in fact FDA Approved, but their other brand the responsive touch is. Try researching nurell or nuresse i can't remember but that is the name they are marketed under in the US and you may find more info.

I think the US brand name is Natrelle and the website has no mention of a choice of gel because only the responsive gel is FDA-approved.

THe FDA website has not been updated since 2006 because no new implants have been approved since then.

The gummy bear is still in clinical trials but this is an anatomical highly cohesive gel.

The Inspira Soft Touch is not available in the US even in a trial so how can it ever be FDA-approved?

I can't provide a link to prove a negative (the link I did provide was from a leading surgeon in the trials quoted on all the US forums).

There isn't a link to provide the positive - that they are FDA-approved or at least in trials. I've googled a lot and there is nothing to say they are. That's because they're not - it's just hearsay on the forums. Some surgeons have even said the CUI is FDA-approved - sometimes they'll say anything - you need to ask to see the proof if it bothers you.

Are you having a BA Miah? Or are u waiting for FDA approval on the Softtouch?

miah wrote:Some surgeons have even said the CUI is FDA-approved - sometimes they'll say anything - you need to ask to see the proof if it bothers you.

Definately doesnt bother me, i know they are a high quality implant here in the UK, even if the US doesnt approve them and i have a lifetime warranty on them i researched the implants well and was happy with them, the US still use saline and smooth implants and are quite behind imo x

This topic has been split. For a discussion about Allergan FDA approval please post here.

To advise Claire between CUIs or Soft Touch, please post here: [You must be registered and logged in to see this link.]

Thanks Roxy