[hourglass]

hey there jim, rucy!  how's it going?  Any news on the breast front?

[Bill]

My understanding of the string problem as it relates to the government is this: The government requires each size of implant be tested and approved.  Since each string implant is different each and every operation would have to be studied for and approved by the government.  

Therefore the cost of say $100,000 would not be a one-time expense, but an every operation expense.  (Please correct me if I'm wrong.)  

[VonKarl]

Hm...perhaps we could pay for a study for say a certain AMOUNT of string...then there would only be one size available.  Hm...I think I saw someplace that there's something like 4000 BEA members...though I'd guess there's only 1000 or less that are really regulars (lurking or not).  So...$100 each.  I'm up for that if someone really manages to pull this off.

[ninjrk]

Quote:
My understanding of the string problem as it relates to the government is this: The government requires each size of implant be tested and approved.  Since each string implant is different each and every operation would have to be studied for and approved by the government.  

Therefore the cost of say $100,000 would not be a one-time expense, but an every operation expense.  (Please correct me if I'm wrong.)    

Depends on how the trial are put together.  The one good thing is that the raw material is already approved so that cuts out quite a bit of testing.  IF you could get a couple of hundred women who wanted Teddi Barret/Melonie Charm size breasts, you might be able to swing it to get approval to run that as a study.  The good thing about that is you could make a strong case for those trials to cover anything up to that size.

The down side is that implants that size do have somewhat regular complications.  The occasional draining isn't so bad, but several of the string-models have had tears in the skin of one size or another, not everybody has Chelsea Charms stretchable skin.  If you go with the mega-implants a decent percentage will have significant complications, if you go with the smaller ones you haven't covered all the bases.  In addition, from the trials I've been involved in, the lack of stability in implant size will be a tough one.  Sure, it's great that Chelsea Charms keeps growing and I've often contemplated sending margarita mix to Melonie Charm by the caseload but that's going to be a tough sell with the FDA.  A really tough sell.

Now, if I could just figure out how to make a stable implant.  A traditional implant envelope of water-permeable material with the string pre-placed or placed after the bag is put into place might work.  You get the lightness of the Prolene with a water impregnated bundle without worrying about tissue ingrowth, the bag keeping the size stable.  Of course, you still have the problem of funding and finding enough women who are interested in implants beyond 500-1000 cc's.

Matt  

[boobrepli]

You know, the best implants will come from ideas.  Makes me think, the plastic surgeons must work with the bea to develope the best 2000cc, 3000cc, 4000cc permanent implants.  The major deal is that with big implants it has to go in steps, i mean that the skin tissue must grow with the implant, so if you wanna go really big, you need to have expandable implants.  

[melonie_charm]

Quote:
You get the lightness of the Prolene with a water impregnated bundle without worrying about tissue ingrowth, the bag keeping the size stable. Of course, you still have the problem of funding and finding enough women who are interested in implants beyond 500-1000 cc's.

Dr. Johnson actually did this with his first set of string implants, surrounding them with a hand-made prolene mesh "bag".  I'm sure that there are 'design options' which would make lightweight huge implants practical and control/eliminate the undesireable side effects.  However, once you have left the realm of using pre-approved medical materials (i.e. prolene suture string or prolene mesh), you open Pandora's box in regard to FDA testing procedures and DEVICE approvals.  This I'm sure was the problem that Dr. Johnson faced when the FDA ruled that using prolene suture string as a breast implant exceeded it's general approval for sutures.

If any approval process and testing procedure is involved, you then have an insurmountable obstacle of testing costs versus probable sales.  99.99% of women who want breast implants are content with sizes of 800cc or less, which are readily available.  The remaining .01% of women who would seek larger implants also have to balance the cost factor, and could never justify an 'inflated' implant cost of $10,000 plus necessary to amortize the costs of testing and approval over such a small group of potential customers.

Quote:
Makes me think, the plastic surgeons must work with the bea to develope the best 2000cc, 3000cc, 4000cc permanent implants. The major deal is that with big implants it has to go in steps, i mean that the skin tissue must grow with the implant, so if you wanna go really big, you need to have expandable implants

It's also very ironic that the one place in the world which has already developed the technology and manufacturing procedures for very large implants, Western Europe, is also not very appreciative of girls with huge breasts !

Adjustable implants and very good permanent implants in all of the sizes you mentioned ARE available in Western Europe !  However, there is very little demand for them from European girls, and of course they lack the FDA approvals necessary to be used in the USA and Canada. Even a well established and profitable European implant company has come to the decision that the extra sales in the US and Canadian markets which would stem from FDA testing of its implants (even standard sizes) is NOT worth the tremendously high costs involved.  
 

[ninjrk]

Quote:

Quote:
You get the lightness of the Prolene with a water impregnated bundle without worrying about tissue ingrowth, the bag keeping the size stable. Of course, you still have the problem of funding and finding enough women who are interested in implants beyond 500-1000 cc's.

Dr. Johnson actually did this with his first set of string implants, surrounding them with a hand-made prolene mesh "bag".  I'm sure that there are 'design options' which would make lightweight huge implants practical and control/eliminate the undesireable side effects.  However, once you have left the realm of using pre-approved medical materials (i.e. prolene suture string or prolene mesh), you open Pandora's box in regard to FDA testing procedures and DEVICE approvals.  This I'm sure was the problem that Dr. Johnson faced when the FDA ruled that using prolene suture string as a breast implant exceeded it's general approval for sutures.  
 

True enough.  my hope would be that it could be submitted as a final implant rather than an evaluation of different materials.  We use water permeable silicone-based sheet for creating barriers in neurosurgery, some of that might scale up to form an implant capsule.  The problem with the Dacron style meshes is that they're designed to cause tissue irritation and promote tissue in-growth which would be undesirable in an implant unless you want a rock-hard ball of fibrous tissue.  Of course, if it's going to be totally encapsulated with a shell it might be easier to use some of the polypropylene beads used in ortho surgery for filling bone defects.  After all, the shell will minimize the main property of the Prolene sutur, that of expansion.

As you stated, the real problem is the 99.9% of the women only want 250-800 cc, so while saline filled implants work just fine an are already approved there's no drive to design larger implants and take them through the process.  The Prolene filler works great for 3000+ cc implants, but what's the market?

Matt  

[MasterDragonfly]

I think I've stated this before (if not in this thread, then elsewhere), but....

On the one hand, there are women who require more than one surgery to get to their target size.  I'll be daring and say that not all women who require more than one surgery are shooting for 3000cc (eg, it could be a more modest 1500-2000cc).


On the other than we have the controversial string implants, which have a reputation for unchecked growth.

Somewhere in the middle there exists the transition technology of post-op expandable implants.  Which, if you think about it, has the fundamental ability to grow, like the string implants.  The significant difference is that the post-op expandables have known minimum and maximum (recommended) cc volumes prior to surgery.  However, a) the delta between minimum and maximum in the post-op expandable pales in comparison to the string implant, and b) the rate of growth is determined by how often the patient returns to the doctor post-op, and how much is added each time, whereas the string implants seem to grow at a rate the body determines.

It seems obvious to me that one could use string implants to allow the breasts to grow to the target size (or perhaps just shy of the target size), then have another surgery to switch to traditional implants.

Benefits include:

- the breasts grow at a rate the tissue more gently accomodates, as opposed to suddenly being made to deal with a dramatic change

- the woman gets to gradually get used to the changes, psychologically and socially

- rather than guesstimating "yeah, I want 2000cc", the woman can decide to switch to traditional implants when she feels she's reached a size she's happy with, which could mean changing to traditional implants sooner than she originally planned on, or holding off until they're big enough for the switch, which means phrases like "I wish I'd gone bigger" or "I wish I hadn't gone so big" should become quite a bit less common than they currently are

Food for thought.

Jim{ruby}