Gummy clinical trial: which practices/surgeons participated?
I have a horrible feeling that this has been asked many times before, but after several rounds of the Search tool I have not found the answer to my question. Is there a list somewhere of the specific practices and surgeons that participated in the clinical trials for the form-stable anatomical silicone implants?
I have been reading that experience and precise pocket formation are absolutely critical to a successful outcome and avoidance of implant rotation, so I want to check whether my surgeon/clinic participated in that trial. My assumption is that surgeons NOT involved in the trial will have only been using these implants for a year or so, and are therefore still honing their skills.
Thanks for any information, and sincere apologies if this is something that newbies annoy the regulars with over and over again.
Comments
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Bump just in case someone knows anything about this!
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Might be simpler just to ask your surgeon/clinic if they participated.
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I know - sounds simple, but I won't meet my BS or PS until the day prior to my surgery and the breast doctor who is my only contact there doesn't know the answer to this question. So I thought I would try the opposite approach as I'm sure this information must be available in the public domain somewhere. So far no luck finding it on the FDA website, though.
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According to this info only a handful of surgeons participated in the trials, but who they are/were is not indicated. The shorter route may be to specifically question your local surgeons about their level of experience with this product. It is possible that a currently practicing local PS may have done more procedures since approval than one who participated in the original trial. Here is the link to the manufacturer's blurb:
http://www.cohesiveimplants.com/articles/natrell-410-fda-approval
It also seems that the numbers of participants in these trials is limited, but a larger amount of info is being gathered in post-study trials:
http://clinicaltrials.gov/show/NCT01853605
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Thanks, SpecialK! Not only was that very helpful, but I found this link of participating surgeons on the site you linked to: http://www.cohesiveimplants.com/expert-cohesive-s...
I'm not sure that these were the ONLY six surgeons participating in the 410/Mentor trials, but it is a start. None of them are my chosen practice, but my guess is that the pre-approval clinical trials would have involved only regular augmentations and not reconstructions, anyway.
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flannery - oh good!
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