|
|
Post by sparticus on Mar 20, 2011 2:38:42 GMT -5
Hoddle
What is your source for .01% complication rate? The only place I have seen that number was from a pro-pmma physician posting on a site (makemeheal.com?).
|
|
|
|
Post by mikehok on Mar 20, 2011 5:47:47 GMT -5
What's the reason Artefill use a bovine carrier as opposed to hydrogel ?
Sparticus, how about writing to the manufacturer ?
|
|
|
|
Post by hoddle10 on Mar 20, 2011 8:13:52 GMT -5
Hoddle What is your source for .01% complication rate? The only place I have seen that number was from a pro-pmma physician posting on a site (makemeheal.com?). I read it on one of the articles posted here or found on googel. But interestingly just before I logged on here I was reading an article where the 1 in 5000 rate was mentioned. "However, even with the Canadian cases mentioned by Dr. Carruthers, the granuloma incidence with Artecoll is 1 in 5,000 patients" findarticles.com/p/articles/mi_hb4393/is_8_36/ai_n29200277/However, I expect they come up with number by asking the registered practitioners how many patients they have treated and then asked how many have returned with a granuloma. This doesn't take into account patients who didn't return to the physician that injected them, when trying to deal with the granuloma. However, it should also be noted that many of those who don't use the product, but diagnose the granuloma's, are also biased. Let's say a patient went to Dr Klein complaining of a small lump. I think it's fairly predictable he'd instantly describe it as a granuloma, as it's only human nature to look for evidence to support your own prejudice. On the other hand, Dr's who like the product will only diagnose a granuloma is the lump is of sufficient size, painful and inflamed. I read an article by one of the Dr's who works Q Med and he said it's very rare anyone ever sends these lumps away for tests after they've been removed. He basically said it's often hard to tell at what point a lump is considered a granuloma and suggested often people are just splitting hairs anyway. |
|
|
|
Post by sparticus on Mar 20, 2011 13:43:54 GMT -5
"the granuloma incidence with Artecoll is 1 in 5,000 patients, Dr. Lemperle said"
That figure is according to Lemperle, so I don't put a lot of weight behind it considering he still owns stock in the company that sells Artefill. The studies we have looked at showed complication rates much higher than that. Think about it, if we have seen studies with a couple hundred people and there were multiple complications, then the rate is obviously not 1 in 5000 or even 1 in 1000.
|
|
|
|
Post by hoddle10 on Mar 20, 2011 14:19:58 GMT -5
But which studies have you seen which compare comlication rates between Artefill and Artecoll? I can't be bothered to go through them all again, but I know for sure the granuloma rate I read in one study for Artecoll was lower than that reported for Artefil. But regardless, these studies are all failry useless and the amount of patients and follow up time is never long enough. I think the main Artefill study that they presented to the FDA was only involving around 1000 patients and over 5 years. But the point wasn't to suggest that what Lemperles says has much significance in terms of real comlication rate, but just that they saw no reason to change the product. I see no evidence that Aretfill is an improvement on Aretcoll and I don't believe any changes were made to the manufacturing process of any significance. If it wasn't for the financial cost of acquiring FDA approval, I don't believe for a second any changes would have been made. So, from that point of view, it doesn't bother me if New Plastic haven't "improved" their prodcut in the way Artes Medical supposedly have.
Does Lemperle own stock in Suneva?
|
|
|
|
Post by sparticus on Mar 20, 2011 16:41:41 GMT -5
I am not even familiar with any studies done on Artefill. I've mistakenly used the the term Artefill interchangeably with Artecoll in my earlier posts because there is a lot of confusion with the info online about them actually being different products. I think the 5 year study posted in the main thread is on Artecoll and I am unaware of any other major study for pmma outside of that. The rest are with animals and case studies. Hoddle, if you find studies please post them here as you read them. That way we all have access to them and it makes referencing and researching much easier. I will be transferring the studies I posted on the main thread over to here. As for the Lemperles, I read a source that stated they both had stock in Suneva, but I didn't save the source and I think there may have been confusion as Artes Medical went bankrupt and was bought out. Here is a source that says both of the Lemperles have no financial stock or interest in Suneva: escholarship.org/uc/item/45b4s0jb;jsessionid=8E077AA369BF7EB9D6F396DA1C134DDA |
|
|
|
Post by sparticus on Mar 20, 2011 16:49:43 GMT -5
Mikehok
I don't know who manufactures the pmma for either Artefill or Bioplasty (New Plastic). If someone tracks the company name and contact information down I willcontact them.
|
|
|
|
Post by gerryc on Mar 20, 2011 17:01:13 GMT -5
|
|
|
|
Post by Skeptical One on Mar 20, 2011 17:22:13 GMT -5
For those who have posted links to various other sites regarding PMMA, please re-submit them to the thread found here: phalloplasty.proboards.com/index.cgi?action=display&board=fillers&thread=244&page=1 (Surgical Methods RESOURCE ONLY --> Alternative Fillers and Chemical PE --> PMMA Articles & Studies Database) This thread is a non-discussion thread, it is meant simply to compile all the links available for this procedure so that it is easier to find. Discussions pertaining to those links can be carried on here. This is true for all other procedures, if you find a resourceful link, please place them in the corresponding sub-forum found over at the Surgical Methods RESOURCE ONLY forum. thanks, -S.O. |
|
|
|
Post by ghostfmj on Mar 20, 2011 19:54:23 GMT -5
I just thought I would point out, when I was browsing BioMedical's website (maker of New Plastic). It states that they are a FDA approved manufacturing facility. I thought I would throw that out there.
|
|
|
|
Post by sparticus on Mar 28, 2011 23:15:24 GMT -5
|
|
|
|
Post by G Tiger on Mar 29, 2011 22:31:20 GMT -5
Interesting....Dr. P. stated, "lower rate of granuloma complications when fillers are injected at deeper sites, presumably because of fewer immune cells in muscle compared with skin." |
|
|
|
Post by sparticus on Mar 30, 2011 16:04:52 GMT -5
Interesting....Dr. P. stated, "lower rate of granuloma complications when fillers are injected at deeper sites, presumably because of fewer immune cells in muscle compared with skin." I'm wondering how this translates to injections in the penis. I'm not versed in the immune cell density at different penile layers. |
|
|
|
Post by sheldon on Apr 2, 2011 11:58:43 GMT -5
Sparticus,
It's good that you are bringing this information and concerns because it's important not to develop 'groupthink' and reminding us that ANY procedure does carry some risk.
PMMA, at least according to this forum, is great in the short term, what will the long term results yield? It's difficult to say...
|
|
|
|
Post by sparticus on Apr 3, 2011 23:05:03 GMT -5
|
|
?