Are CUI implants rubbish ?

The extra £400 is sooo worth it x

sianyoungx wrote:Hi Princessgem, I have CUI implants and I also went with Paul Clarke at Transform. I'm nearly a year post op and very happy with my results :) x

Thank you hun that's very reassuring to hear ! X

CUI are certainly not rubbish, at lot of ladies have them and do love them! I personaly chose to go for the Naturelle implant simply because they have a thicker shell, the CUI are great but it is a hard fact that they do have a higher rupture and ripple rate. If it were to rupture, your implant would be covered but your surgical fees may not be (even if you are promised aftercare you may have a hard time getting it, I had a similar exp to Cookie) as for ripples nothing will be done about that as it's not a *medical* complication. Make your choice based on your own research and feelings but it's worth remembering that where plastic surgery is concerned you shouldn't let the title of DOCTOR fool you. These people, whilst Drs, are business first, it's elective surgery not medical surgery so these people will push you in to a direction that offers them better financial gain, it's just how the industry works. IN terms of having to save anoth £400 I will say that if you have any kind of risk for ripples it's more than worth having that extra safety blanket there, otherwise you will be shelling out another 5k later down the road. As far as FDA, that really has no bearing either way as FDA is to do with the American market, I can't see CUI being FDA approved (I could be wrong) because CUI implants are no longer used at all in the U.S. I hope this helps.

Thanks lovelys you have all been very helpful,  and I know you all have my best interests at heart which is so lovely , sooo glad I found this forum and grateful for everyone who takes the time to respond to me   

Luckily I have a bit of breast tissue there so I'm hoping and praying I won't get rippling and trying to stay positive- however what is the difference in percentage with the rate of customers experiencing rippling with CUI in comparison with Naturelle does anyone know the figures? xxx

CUIs have been produced for the European market from beginning by Allergan.

Rippling depends on the fill of the implant: 100% fill ripple less but are not as squishy. 95% are softer but may ripple more.

Rippling depends also on existing tissue coverage. If you don't have enough- risk of ripples is higher.

xxx

I have no idea on the rates or ripples between the two but I know ripples are at a rate of some where around 50% across the board, ALL implants ripple, it's just a case of weather those ripples are visible or not. Given the rate is so high I think it would be advisable to reduce the risk as much as is possible.

Princessgem wrote:Thanks lovelys you have all been very helpful,  and I know you all have my best interests at heart which is so lovely , sooo glad I found this forum and grateful for everyone who takes the time to respond to me   

Luckily I have a bit of breast tissue there so I'm hoping and praying I won't get rippling and trying to stay positive- however what is the difference in percentage with the rate of customers experiencing rippling with CUI in comparison with Naturelle does anyone know the figures? xxx

If you have bit of tissue you should be ok hun. Your surgeon is experienced and would recommend what he thinks is best for you. All doctors have given an oath to act in patients best interest- commercial or not. In UK they all have to be GMC registered.

Nobody will be able to give you ripple rates as it depends on individual.

Forgot to add that couple of surgeons I saw said they preferred implants that have been around a lot longer xxx

GMC registration means that if the doctors mess up they should be reported to them and it will be investigated xx

I think it's also worth mentioning that asking several Drs/clinics for their opinion might be a good place to start as the issue with forums and such we will always prefer what we have ourselves individually lol ^_^ As kdee mentioned, if you have a good amount of tissue ripples shouldn't be a problem for you and using the 100% fill implant will also reduce your risk. 

From my own exp, I will always recommend the implant I have as I have zero visible ripples with my chosen implant, that is with no tissue coverage as I had Mastectomy prior to my BA in one breast and was barely and A cup in the other, I also had a large implant so the fact I have no ripples could be a walking ad for the brand ha! Good luck in your research!

Yeah.I.had no breast tissue and can only feel rippling 

Girls even.with breast tissue ive seen, see rippling xx

Yeah it's the same as CC, we all have it, just no way of telling if it will show or how bad it will be.

As I say, I know you want to ask ladies their personal stories but we will all prefer what we have ourselves, if a lady here has CUI and loves them she will tell you you don't need to spend the extra cash, if you ask a lady who has Naturelle she will tell you that hers are great and she's happy she spent the money, it's so individual to each of us so doing your own research and sometimes going with your gut is what will really help you. Try to get as many opinions as you can, because oath or not I can tell you from personal exp (as can many other ladies here) many Drs, even those with great reps, fantastic work, awesome aftercare packages and so on can stil have the *cowboy* moments, they will never knowingly harm you or put you at risk but they will often try their damndest not to give you what you are due. This is more true of the large commercial clincs. I love my breasts, I had them done at a large commercial place so I won't speak down of them, it's just this is an industry where you need to have your eyes open at all times.

I have cuis. I had the money for the other implants that the assistant was trying to push but I went with what my surgeon recommended and she said these were just as good and felt more natural. Too late now I suppose. Not sure I like this thread as it may cause some ladies to worry unnecessarily.

I have spoken to our boob guru cookie and she has sent this regards cui and fda for me to copy for you ladies  ...

The only silicone gel breast implants that have FDA approval are: Allergan Natrelle Responsive, Allergan 410 (anatomical), Mentors Memory Gel, Mentors Memory Shape and the Sientra silicone implant. 


Information from here: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm063871.htm


CUI's have never had FDA approval. 


Transform buy these implants in bulk at a discounted price to gain the most profit from their sales, hence why their surgeons may push these implants - the more CUI's sold - the greater the profit. 


That's not to say they're a bad implant, they undergo the same stringent testing as their superior, the Natrelle range, but...they are a budget implant lacking the addition of an extra layer of protection should you be unfortunate to have a rupture thus lessening the risk of a silicone bleed beyond the breast capsule, as well as the £700 that Natrelles offer to help toward any costs should you have a rupture in the first ten years. Unlike Natrelles CUIs also have only a 10 year warranty in comparison to the Natrelles lifetime warranty. 


As technology has advanced however so have Allergans breast implants introducing their new 5th generation implants - the premium implant being the Natrelle Soft Touch and their budget implant, the CMH. These implants have a lowered the risk of CC due their 100% fill as opposed to the older 4th generation implants which have a 95% fill (the Responsive and CUI). 


Neither the Soft Touch or the CMH have FDA approval.

I have CUI implants and after reading the above am alittle worried!

But theirs nothing I can do about it now. But was told to replace them in 10years which I'm ok with.
But now wishing I'd had the natrelle implants :-S

Natrelle™ implants: 
Offering 142 size and shape options to achieve the exact results you’re looking for
These implants meet rigorous standards and have an exceptional safety record
The outer shell is made up of 6 protective layers
The surface has two layers of texturisation
Available in 100% gel fill
CUI implants:
Transform offers a 10-year warranty against rupture and severe capsular contracture* in CUI implants.
A popular high quality option for breast augmentation.
Manufactured in US Food and Drug Administration (FDA) approved premises.
CUI implants use FDA approved silicone gel.
146 separate quality checks ensure exceptional safety standards.
The final stage of production involves dry heat sterilisation for 30 hours.
The outer shell consists of 5 protective layers.
There are 70 size, shape and projection options within the range.
Choose from a 95% or 100% gel fill.

Ok feel a bit better now.

It's the FDA information you should be looking at, not Transform's. Their clever wording can make things look better than what they are and the reason they try to make CUI's look so good is because they buy them in bulk so it's cheaper for them if patients have CUI's. The CUI vs. Natrelle debate can go on forever, everyone has different opinions and preferences on what they want to put into their body. Some want FDA approval, the extra layer, less chance of rippling etc.. others don't mind going for the budget (but still safe) option.

This is from reputable plastic surgeon. 
What Is FDA Approval?

• A form of regulatory sanction granted by the Food and Drug Administration
  
• They assess medical devices (like Breast Implants) according to safety and effectiveness 
  
• A risk classification from 1-3 is given to decide if the product is safe to sell on the open market
  

Since 1988, Breast Implants have been classified Class III ‘High Risk’ by the FDA so require the most stringent application procedure for approval, known as a PMA (Premarket Approval Application). This means the manufacturer must submit clinical data and research to back up any claims about the product. They also have to prove that their implants are not only safe but effective too.
The important thing to note is that the FDA are an American governing body who (according to their website) only monitor and approve the manufacturing, repackaging, re-labelling and importing of medical devices which are sold into the USA market. This obviously means that if a product is not an American brand and the company has no intention of trading the product into America, there is no need for the product to seek and gain FDA approval.

What Is the CE Mark?

• Essentially the EU equivalent of FDA Approval
  
•  A set of legal requirements / a declaration of conformity for all medical and aesthetic devices which must be rigorously followed before they can be sold on the European open market
  
• Manufacturers must comply with European health, safety and environmental Product Directives, with the product meeting set standards for safety and quality
  
• Non-conforming products can be withdrawn by customs and law enforcement officials.
  

As with FDA Approval, because Breast Implants are designated Class III (high risk) medical devices, they require a CE Medical Mark rather than a standard CE Mark which ensures the same depth of clinical data and research is submitted before a product can be approved for open market sale. The CE Medical Mark also guarantees that the device has been tested not to interfere with hospital equipment, particularly life-saving apparatus.  
Are Implants with FDA Approval necessarily ‘Higher Standard’ than those with the CE Mark?
Not at all. This is a common myth which has developed in the UK through lack of understanding and information. It has grown due to unchecked rumours on forums and social media, coupled with the American suppliers / providers’ obvious eagerness to exploit this belief to seem as if their products are somehow superior, regardless of the lack of factual foundation.
Part of the confusion may stem from the fact that lower classed devices in the CE Mark system do not require clinical research data in order to gain approval. (The ‘Medium Risk’ device classifications on the FDA system, however, also have to submit far less rigorous clinical data and receive clearance much more easily.)  This may have been misunderstood and applied to Breast Implants when, in fact at this level, the two systems are much of a muchness just one is European and the other American.
In his brilliant article ‘CE No Evil’ for Cosmetic News magazine (December 2011, p.22-24), Mike Murphy concludes by admitting that “neither CE nor FDA approval guarantees that medical/aesthetic equipment will deliver good clinical results. They are essentially safety tests with large variations in clinical efficacy”.

Yes, the FDA approval isn't the be all and end all for some people, but it's definitely an added benefit, along with the other benefits of Natrelles: lower rippling rates, lower rupture rates, the extra layer, and being stronger & sturdier. Natrelles are better in every way, it's fact. But it's personal choice in what you opt for.

this is thread isnt to make people worry and some threads we aint all going to like

for me ive had quite a bad expericance so I tell my story as its what has happened to me and i will never ever sugar coat anything when it comes to a BA as there are complications and they can happen to anyone of us at anytime thats just the risks involed with having a BA


the wording of the CUI were MANUFACTURED in a FDA approved premises is very cleaver wording

at the end of the day we all choose, with the help of our surgeons what we go for and I like, Princess went for the Natrelle as it had all the lesser risks again rippling, CC, etc etc, however I got a bad case of CC so i do have problems, the rippling like I keep saying was a huge thing for me, as no one will do another free reop to sort the rippling as its cosmetic and not medical so for me I took the natrelle for the rippling fact

so if your happy to haveor have had CUI then you shouldnt be worried at all as thats the implant that you have read up and you are happy to have in your body for however many years xxx

loui1981 wrote:Not sure I like this thread as it may cause some ladies to worry unnecessarily.

I see no intent to worry or scaremonger any ladies in this thread Loui and if women are concerned at all about anything they read then they're free to make their concerns known here on the forum and 'their' concern will be responded to accordingly, enabling 'them' to proceed with their surgery fully informed and happy with the information they have acquired...if they're not happy, this then enables women to possibly extend their research if they feel it necessary for them to make a different choice that may better suit 'their' wants from their own surgery.

In response to your concern Loui, its entirely your decision whether or not you want to continue following this thread just as it is every other woman here, so if you don't 'like the thread'....you have the choice not to read it Loui, leaving those who do find it of interest the benefit of the information here.

I personally pay no attention really to FDA approval, I live in the EU and 'my country's' standards were fine 'for me' some of the best implants on the market used by BAAPS surgeons are not FDA approved....however a BAAPS surgeon will only ever be likely to choose a premium implant. This includes non FDA approved implants made here in Britain called Nagor, they too have a budget (GMX) and a premium (Impleo) choice, but a BAAPS surgeon would only use the Nagor Impleo.

ALL implants currently used in the UK are EU approved and a 'safe' product.

I have CUIs myself. I knew when I opted for them that they would only be with me for the short term as I plan to reduce in the near future. They are of Allergans budget range but they're no less 'safe' than the Natrelle range.

What I would say to anyone having a BA now is to weigh up all the facts yourself, don't just settle for the implant a surgeon suggests... As with a clinic such as Transform, it benefits 'them' to offer the implant 'their employers' wish to promote, so do extend your research beyond that and explore the facts for yourself.

Technology has moved on from the 4th generation implants, those being any silicone implant 95% filled such as the CUI and the Responsive and a lot of research has since given us a choice of an implant that lessens the risks of CC which is a complication that can happen to any one of us at any time from the day of being implanted to the day you either have a complication and require a change of implant or you make a choice yourself to have your implants explanted/exchanged. So this in itself is a big plus in 'my personal opinion' as well as the lessened risk of rippling. The majority of us have rippling to some degree but its VERY few that have 'visible' rippling. Rippling that can be felt, especially when leaning forward either in the inner cleavage or to the outsides of the breast but as I said, if it can only be 'felt' this its nothing to be concerned about at all.

So.... You have a choice that I didn't have when I had my replacement (the 5th generation implant wasn't available then). You lucky girls that are in the process of having your BA have so many 'safe' options available to you!   

So you can either choose a 4th generation implant be that a budget or premium implant with a 95% fill. The benefit of these over the newer implants is that they are slightly softer, but in saying that you'll achieve a nice natural feel from any of the implant choices after full recovery - in the Allergan range these implants would be the Responsive (premium) and CUIs (budget)

Or you can opt for the newer 5th generation implant with the benefit of a lesser risk of CC and rippling, again be that a budget or premium implant - in the Allergan range these would be the Natrelle Soft Touch (premium) or the CMH (budget)

Which implant is best 'for you' is the implant you feel 'you've' researched to your own satisfaction and feel happy and confident with the choice 'you' make and its NEVER too late to change your mind, but be aware with a clinic such as Transform they tend to buy the premium range in to order on a patient by patient basis so they won't have a stock of these and you'll probably need at least a week or more to get them ordered if they were your preference, but if a different implant to the one suggested to you were now your choice after your own research, then if need be, it would be far better to wait for the implant to come in stock and be happy to live with the choice you made, rather than, settle and have possible regrets later.

Just to add that for those who's main concern is CC then the 5th generation implant would most likely be your best option. If this option were available to me I'd have personally have had those, 'for me' the lesser the risks... The better for you. But although the risks may be higher with a Responsive or a CUI, if that's what suits 'you and your needs' then all is well!

Just to add - be aware that the implant with the very least risk of CC is a 'Polyeurothane' implant. Here in the UK surgeons opt for the 'Pure' range.

Transform however don't supply these implants and they are only an option through a BAAPS surgeon because the placement of these implants require great skill and surgeons do need to be trained to use them....but I just thought I'd throw another option out there if anyone was interested.  

so GOOD to have you back COOKIE   
As always thank you for your wisdom.
Really missed you on here. 

I hope you are feeling a little better.

Big hugs xxxx

slightly off topic, but are motivas not FDA approved?

Ooh opened a can of worms here didn't I oops! I didn't mean to worry anyone sincerely sorry if I have -maybe my wording are CUIs rubbish wasn't very appropriate ! I didn't mean it in that way, or to make anyone who has them feel inferior ;( 

But I also think anything that might be "worrying " should be raised here , so that people can weigh it up and make their own minds up what is right for them. I don't think we shouldn't talk about it incase it causes concern as this is what this forum is for and why it's so very very helpful! 

I wouldn't know anything about BA hardly
At all of if wasn't for this site ! I've learnt so much and so grateful to you all xz

Princesses not at all it was something I needed to know so asked, I'm always 100% honest and can.ONLY go on my.own experience 

We all want diff looks etc etc so speaking to our own surgeon who.know our bodies is the way to.go.xx

:-( wasmy being funny just as someone who suffers with anxiety and someone learning to get over that and start loving my boobs I found this thread worrying personally.