Implants that are FDA approved...are yours?

I thought Mcghan implants as in the Inspira and Anatomical responsive gel range (apart from CUI and perhaps soft touch) were approved by the FDA?

So This document states the implants that are FDA approved by Allergan:


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Point 5 in the pdf document has a table of the FDA approved implant styles (10,15,20,40,110,115,120)

but when I try and find these implants in Allergens catalogue most of them are not there!!

The only style nos listed are: 410, 510, 468 168, 133, 150. The only ones that are there are the 110s and most surgeons dont seem to recommend using them. All the talk is of the 410s or Inspira range.

Im guessing perhaps its because the FDA approved ones were approved back in November 2006 which is quite a while ago, so maby this is new technology that hasnt quite caught up, due to the amount of time it takes to get approval from the FDA due to clinical trials e.c.t

So has anyone actually had FDA approved implants?

Hmm not sure on this hun apart from like you said i know the cui ones are not fda approved.

I have mentors which are approved i think theres only mine and the inspira ones that are although im not entierly sure, i know lots of ladies on here have the cui implants and have had no problems the only ones that keep to seem coming up with problems is the pip implants.

x x

Exactly. While CUIs are part of their budget range, there hardly seems to be any problems that occur due to rupture or leakage. I've not hear of any on the forums.

The only thing I can think of is... if the implants are a newer range and have phased out the previously FDA approved implants, then clinical studies wouldn't have been completed yet, thus the FDA not giving them their seal of approval.

Perhaps Nads can shed some light on this?

xx

Cakey-baby thanks for the reply. I'v had a little look at the fda approval order for mentor and can see the style numbers that have been approved for Mentor memory gel are mod profile style 7000, high profile style 4000 and mod plus style 8000. Mentor do 3 levels of cohesiveness and ther is no mention on the approval order which level has been FDA approved.

I have also tried to find these style numbers in Mentors product cataloge and they are not there! So Im finding it difficult to find FDA approved implants that can be used today..maby these were phased out to as Roxychick suggested might have happend with the mcghans?

Going back to the Inspiras i had previously thought these have been approved also, but have found no evidence so far to suggest that they are.

RoxyChick wrote:

The only thing I can think of is... if the implants are a newer range and have phased out the previously FDA approved implants, then clinical studies wouldn't have been completed yet, thus the FDA not giving them their seal of approval.

xx

What I cant understand is, that it took so long to get these implants approved by the FDA so why phase them out?, surely if they have been approved by the FDA they are considered a "safe" implant??

Maby Allergan and Mentor go through this approval process and get them approved because its good business to say their company uses implants that have been FDA approved, and by saying that, it would be easy to assume their whole range of implants are FDA approved.

Who knows?!, Im beginning to think this FDA approval thing actually isnt all that important after all as the ones that are approved are older implants which for some reason seem to vanish anyway! and technology is catching up all the time, so I would assume that the technology is there to get better.

I think, whats perhaps more important (as Roxychick has suggested) are the rupture and complication rates of implants in this country. Just because C.U.I implants wernt approved and are cheaper dosnt meen they are worse implants.

I did think perhaps the inspiras/410s were just a money maker as these seem to be the more expensive ones that get used by the surgeons, but Iv since found out that the surgeons dont get paid any more by using them, its the manufacturer that gets the money.

So what are the real differences between the actual gel composition of the inspiras/410s to that of the CUIS?? I guess ill never really know and I will therfore have to trust my surgeon.

I do think there is a fine line though as some say its in the surgeons best interest to give you implants that dont cause you problems, but if you go back to them for a re-op then they get paid again, so how much should you actually trust a surgeon? hmmmm.

I really dont care much about fda approval your right hun it isnt that important, all implants have chances of rupturing or something going wrong plus no matter what implant you get it isnt going to stop cc etc (apart from textured implants are supposed to)

I suppose its piece of mind knowing they have gone through a lot of testing though.

xx

danables wrote:Maby Allergan and Mentor go through this approval process and get them approved because its good business to say their company uses implants that have been FDA approved, and by saying that, it would be easy to assume their whole range of implants are FDA approved.

Hmm, possibly true, and if so it's very sneaky of them. I can see that being a very good marketing plot. By only spending the money to get one set of implants FDA approved word will get around that have FDA approval, despite the fact that they phased them out and eventually, aren't used anymore.

danables wrote:I think, whats perhaps more important (as Roxychick has suggested) are the rupture and complication rates of implants in this country. Just because C.U.I implants wernt approved and are cheaper dosnt meen they are worse implants.

That's the way I felt. I did my research on CUIs and was happy with their shell integrity and the fact so many women have them and rupture rates for my surgeon were slightly below average I had peace of mind they were going to be fine for me. if it was PIPs on the other hand I'd be very wary...

danables wrote:I did think perhaps the inspiras/410s were just a money maker as these seem to be the more expensive ones that get used by the surgeons, but Iv since found out that the surgeons dont get paid any more by using them, its the manufacturer that gets the money.

That's true. As Snake said, surgeons that work via mainstream clinics get a pittance of the price we pay. The rest goes on the implant (which again, isn't that much cost-wise) and the company. Probably to be spend on marketing, advertising, and their sales people.

danables wrote:I will therfore have to trust my surgeon.

That's the best way to do it lovely. You can literally drive yourself mad going thrrough implant sizes, models, projection etc etc etc. If you've done your research on your surgeon, if you trust his judgement 100% then you've done all you can do.

As cakey said, if something's going to go wrong, it probably will happen regardless of implant/surgeon.