Being part of a study? Opinions? (long post!)

My BA is booked for 3rd July with Michael Payne at the Hospital Group - I went to see him today to have another consultation and clear up a few last questions about sizes etc and after re-examining me and having a chat he told me about a trial / study he is involved in and said I would be a good candidate.

Basically I have opted to have the Allergan Natrelles (sorry about spelling!) but he has been chosen as the UK surgeon to take part in a study for the next version / upgrade of this implant...it has been developed with more texture which the idea is to hopefully reduce the rates of capsular contraction. There are 5 surgeons who are doing this UK, Stockholm etc and each will select 10 patients in July who meet the criteria to take part. The implants have been CE marked and are fully approved for commercial use in Europe.

If I take part then I will have: in depth medical history, reasons for BA, contraception and medication discussed, full and thorough physical exam of my breasts/ underarms, photos of before, questionnaire about my feelings about my breasts now, an ultrasound scan of my breasts to analyze the tissue all before the BA.

After the BA the study will involve me seeing my surgeon a minimum of 8 times over the next 5 years at scheduled intervals for 60minute appointments to discuss contraception, menstrual cycle(?) take photos, measurements and examinations, Baker grade assessment, breast pressure measurements, repeat the first questionairres, follow up medical questions and an ultrasound at each appointment.

Allergan have insurance for and will cover me for re-ops if capsular contractions occurs within 10 years/ ruptures etc and the hospital group aftercare policy stands.
I would be able to opt out of the study at any point with no problem/ fees etc.

What do you girls think? Would you agree?

Im thinking the 8 * 1 hour long visits with Mr Payne can only be beneficial surely?! And if his work is being judged with pictures etc as the UK surgeon taking part he is going to aim for amazing work!
He isn't pushing me at all, it is fully my own decision and I can even opt out on the day of my BA if I change my mind.
xxx

It seems like it would help you know you are getting the best care possible as it is a study of your surgery so that would probably make me feel alot safer and and all those appointments are great, i just dont understand why they want to talk about contraception and ur menstrual cycle i dont understand what that has got to do with your surgery unless im a complete dummy xx

Allergan already have an excellent proven reputation, so to be carefully monitored would give you that additional reassurance and you'd be benefiting from the next generation implant too... But I'd personally need to hear this from Allergan too and not just trust the word of your surgeon hun. I'm not saying your surgeon would lie to you, but surgeons lying, isn't unknown.

Mr Payne, not being a BAAPs member, I will admit raised an eyebrow as I would have presumed those surgeons would have been targeted by Allergan over others to do their study, but then maybe they've just targeted the popular clinics???

I'd just personally require further info babes and not just from that of the clinic or surgeon before deciding anything. xx

I would go for it without hesitation. It sounds really good and you will have so much peace of mind, especially about having c c, which I had and is awful. xx

Twinkle - I don't get that bit either...I will ask Mr Payne when he rings me in a day or so to answer any questions I have about this giant info pack i've got!
My only thought was because breast tissue can feel different at different points in your cycle maybe? Or I could be making that up!(Not mine - I have none ) But there is a lot of emphasis on that! Strange...xxx
Cookie - I have a huge info pack to read through and it has numbers and contact details of Allergan people so I will give them a call in the morning and get some more info from themselves :) thank you xxx

Cookie has made a very good point I wouldn't of thought of checking that, everything is probably fine but you can never be too careful xx

Yea, I hadn't thought about that either...getting so close I have a million other things swishing around my head it didn't occur to me! Thats why this site is AMAZING! Extra perception :) xxx

Oh I don't know I've never heard that :heehee: but I don't know anything about boobies I'm a boobie dummy I will know more when I've got some haha, that is great that you have got lots of information and definately a good thing that you can ring allergen yourself seems like it would be a very good thing if this checking your cycle thing is nothing to worry about which hopefully it isn't xx

Does it give a name in the pack of the implant hun? xx

It doesn't have an implant name; but the study title is: European new texture implant clinical experience with round breast implants.
And the study number is: ENTICE-001

I will find out more details from Allergan tomorrow and let you know :) xxx

Thanks sweetheart, it would be really interesting to know more

Jut one more question for you to ask babe - why are they only 'European' and not 'international'?

this is a very interesting topic to watch... I thought at first, it is too good to be true, but it looks legit with the pack he has givenyou etc and how else do they do implant trials without trying them in on people. very good points raised by Cookie as per usual. what would cross my mind is why are you a perfect testee?
would love to know more info when you get it xxx

Sorry I haven't updated this, just got swept away in the last few days countdown and sorting my things out etc :)
The implant is called NaturellePLUS...very imaginative haha!
It is a European study because were in Europe, all 5 Euro countries will be collated together, America have there own going on too, which has already started...which makes sense!
I spoke to someone at allergan prior to agreeing and then on Monday I went for pre-op pics, tests etc and met an Allergan rep who was more than helpful. Then tuesday they went in :)
The contraception/ menstrual cycle thing is because if I get pregnant then they will end my study part (all cover etc still stands but they won't continue with using me as a casestudy) BUT the thought of my own kids fills me with dread so defo not for me
I was a good candidate because I met a bunch of requirements to take part and i'm 1000000% not planning to get pregnant ever, let alone the next 5 years!

If anyone is interested I could (probably! - technologically dumb!) scan the info pack up and email it if anyone wanted a read! xxx

Wow this actually sounds really interesting to take part in - its something I would have taken up had I of been in our position!x

Ooh I take it you went ahead then hunni? How did it go?x

Sounds like you're going to be well taken care of Abbie and CONGRATULATIONS babe! xx

Yea I went ahead with it! On monday night I had a 2 and bit hour appointment with Mr Payne, his assistant lady, Allergan rep and so I was very reassured it is a good thing to do!
Happy so far, but oh my god i'm already sick of this binder thing!!! Driving me crazy, swear most of my discomfort is from that more than any pain! But all be so worth it in the end xxx

Ice packs will be your lifesaver, so I seriously think you should invest if you haven't already. Wilko's sell reuseable heat/ice packs which are amazingly cheap.

Did you have to pay the regular price out of curiosity for your BA? X

Packs of cotton wool wadding helps with a binder too hun. Especially under your arm pits and rib area. I had to wear a compression band which by doG was it tight, but I just shoved the wadding everywhere the band was hurting me. Xx