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Hi and welcome to Breast Buddies Forum!

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Are the Mcghan SOFT TOUCH implants FDA approved?

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RoxyChick
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Are the Mcghan SOFT TOUCH implants FDA approved? Empty Are the Mcghan SOFT TOUCH implants FDA approved?

Post by dbs 23rd May 2009, 6:48 pm

As these have a different gel make up as they are supposed to be softer?
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Post by RoxyChick 23rd May 2009, 10:37 pm

I honestly don't think they are.. I'll have a check over tomorrow though

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Post by Annie66 23rd May 2009, 10:56 pm

well, my understanding (and I could be wrong!) is that all Allergan /Mentor cohesive implants (gummy bears) are still considered 'investigative' devices by the FDA. Only the semi-liquid silicone range ('naturelle'?) have FDA approval, and even this remains contingent on them producing satisfactory results at the end of an on-going 10-year trial due to finish in 2016.

[You must be registered and logged in to see this link.] (which I think you’ve read)

In the UK, both types of silicone (semi-liquid and cohesive) are approved by MHRA

[You must be registered and logged in to see this link.]

I’ve also read on forums that the cohesives were approved in Canada in 2006, but I haven’t directly checked that myself

As you probably know, longitudinal controlled trials yield the strongest type of evidence, but, by definition, they take a long time to complete. In one of my consultations I asked ‘am I effectively opting into a longitudinal study?’ and the ps said ‘honestly, yes’. But my personal feeling is that the US is being extremely cautious about this issue because it is a highly litigious environment. I’m satisfied with MHRA approval.

Why don’t you post this in Snake’s forum or his blog? He’d be better able to give you an informed answer …
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Post by Mia 24th May 2009, 12:06 am

To the best of my knowledge they are not FDA approved. Annie's suggestion to seek expert advice would be the best route for confirmation.
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Post by dbs 24th May 2009, 7:34 am

Iv come to the conclusion that most of the implants that were FDA approved dont actually exist to use today in the U.K anyway.

Iv checked the ranges against the manufacturers catalogue and all but one (mcghan 110s) are not in the catalogues, and Iv never heard of anyone whos had the 110s either.- The suregons dont seem to recommend them.

Annie66. Thanks for your help. Unfortunately Snake will no longer reply to my posts on his blog. Back in February I posted on his blog about a consultation I had with Transform. He seemed to think I worked for them (yet i had nothing nice to say about them!) I was simply reiterating what they told me, I didnt believe what they were telling me so I went to him for advice. I didnt read the rules on his blog and posted the name of the company/surgeon (which got edited out anyway) perhaps that was why he thought I worked for them?!, he has since not replied to any more of my posts.

Ill try and pop him a message on here, maby he'll reply as its a general question.
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Post by RoxyChick 24th May 2009, 11:29 am

Annie66 wrote: But my personal feeling is that the US is being extremely cautious about this issue because it is a highly litigious environment. I’m satisfied with MHRA approval.


I agree. I think with all the silicone/saline debate the FDA need to be extra (and IMO overly) cautious about the implants they approve.

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Post by nads 24th May 2009, 7:20 pm

RoxyChick wrote:
Annie66 wrote: But my personal feeling is that the US is being extremely cautious about this issue because it is a highly litigious environment. I’m satisfied with MHRA approval.


I agree. I think with all the silicone/saline debate the FDA need to be extra (and IMO overly) cautious about the implants they approve.

xx

I agree too. I think the US are behind us and other parts of Europe, Canada and Australia in terms of implants as they still use saline which has been proven to grow mould in and make people very sick, whereas we only use cohesive silicone. I'm happy with my implants even if they arent FDA approved as i know they are of a high standard and have been tested x
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Post by RoxyChick 24th May 2009, 7:21 pm

Very true nads, I've seen so many pics of saline implants filled with mould... makes you wonder how they can still implant them.

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Post by JoanneR85 24th May 2009, 7:32 pm

Thats gross, why would anyone want them in their body if bacteria is going to grow.
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Post by nads 24th May 2009, 7:34 pm

Alot of US girls are still scared of silicone after the scare as they were banned and also saline is nearly $1000 dollars cheaper and alot of young girls without much money just opt for it as its cheaper, sad but true
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Post by JoanneR85 24th May 2009, 7:35 pm

I guessed cost had something to do with it.
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Post by RoxyChick 26th May 2009, 3:00 pm

Yeah, it's a shame really. Saline is a great idea in theory (it's only saltwater so if they leak it's safe blah blah) however in practice it's just not the best technology out there.

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