Are the Mcghan SOFT TOUCH implants FDA approved?
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RoxyChick
dbs
6 posters
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Are the Mcghan SOFT TOUCH implants FDA approved?
As these have a different gel make up as they are supposed to be softer?
dbs- BJSF Elite Member
- Number of posts : 1142
Location : Hampshire
Re: Are the Mcghan SOFT TOUCH implants FDA approved?
I honestly don't think they are.. I'll have a check over tomorrow though
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Re: Are the Mcghan SOFT TOUCH implants FDA approved?
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 …
[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 …
Annie66- BJSF Elite Member
- Number of posts : 1828
Location : London
Re: Are the Mcghan SOFT TOUCH implants FDA approved?
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.
Mia- BJSF Elite Member
- Number of posts : 5926
Location : u.k.
Re: Are the Mcghan SOFT TOUCH implants FDA approved?
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.
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.
dbs- BJSF Elite Member
- Number of posts : 1142
Location : Hampshire
Re: Are the Mcghan SOFT TOUCH implants FDA approved?
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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Re: Are the Mcghan SOFT TOUCH implants FDA approved?
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.
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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
Re: Are the Mcghan SOFT TOUCH implants FDA approved?
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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Re: Are the Mcghan SOFT TOUCH implants FDA approved?
Thats gross, why would anyone want them in their body if bacteria is going to grow.
JoanneR85- Active BJSF Member
- Number of posts : 187
Location : Yorkshire
Re: Are the Mcghan SOFT TOUCH implants FDA approved?
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
Re: Are the Mcghan SOFT TOUCH implants FDA approved?
I guessed cost had something to do with it.
JoanneR85- Active BJSF Member
- Number of posts : 187
Location : Yorkshire
Re: Are the Mcghan SOFT TOUCH implants FDA approved?
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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