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Post by Skeptical One on Mar 16, 2011 23:41:13 GMT -5
Pardon my conspiratorial way of thinking, but the American marketing system (I'm American so this is in no way an insult) seems to be more focussed on providing a temporary fix or product so that one ultimately has to continue purchasing. Permanent solutions are simply bad for business. This may or may not be applicable to the American Physician way of thinking...but at the cosmetic level it does become more questionable.
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Post by Skeptical One on Mar 16, 2011 23:56:29 GMT -5
online.wsj.com/article/SB118834446251311594.html An article about Dr. Klein and his criticism of Artefill. It is remarkable the lack of data Dr. Klein and like-minded physicians have on the matter (let alone the fact that they aren't examining non-bovine based PMMA brands). One physician accounted for a "half a dozen" complications based on a procedure that is done in the thousands abroad. While I am desperately looking for a valid point from Dr. Klein, I'm failing to see anything that stands to be alarming with respect to PMMA injections. If anything, it appears that proper injection technique could be the biggest culprit in long-term issues. And as for my conspiratorial way of thinking (lol), the article states... The role of physicians who become activists, like Dr. Klein, is complicated in a world where doctors often are paid by companies to perform scientific research and teach others how to use their products. In this case, Dr. Klein has past and current ties to ArteFill competitors. From 2000 until last April, Dr. Klein worked for Allergan Inc., which sells Botox and Juvederm, and since 2004 he has been a consultant to Restylane maker Medicis Pharmaceuticals Corp. Dr Klein, who made $250,000 a year from Allergan for several years, says such ties "have nothing to do whatsoever" with his concerns about ArteFill. "I refuse to see the field of soft-tissue augmentation destroyed," he says of his motivation. Allergan and Medicis say that Dr. Klein is acting on his own.
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Post by Skeptical One on Mar 17, 2011 0:02:12 GMT -5
Here is another site where a Doctor responds to a question about PMMA injections for the buttocks. What is absolutely remarkable is how the doctor goes on to make PMMA sound like a nightmare without providing ANY kind of evidence, statistics, or personal accounts on the matter. Furthermore, he (hilariously in my opinion) offers his own alternative for buttocks augmentation at his surgical center using his (NON-PERMANENT) fat technique. ROLLING EYES! www.realself.com/question/butt-injections-safety-success" There is a LOT of information on the internet which is simply not true and misleading about buttock augmentation. If you look you can find glowing reviews of almost every technique as well as people cursing the day they had the procedure done. When it comes to PMMA injections you will see a trend in the information. The people who are claiming how good PMMA injections are and how safe it is to do are not actually medically trained let alone doctors. Whereas the negative information is generally from two sources, doctors and people who have had the treatments and have problems. There are some posts from patients that have had the injections and are happy though frequently these posts are found to be actually advertising for centers or doctors performing these procedures.
In the USA PMMA is not FDA approved for injection into the buttocks. In fact, I am not aware of liquid PMMA being FDA approved for ANY purpose. If treatments were so safe and results were so good, don't you think a company would have submitted their product to the FDA for approval by now. The technique has been around for many years. The plain truth is that the treatment has a very high rate of complications. These complications can be quite deforming of the body and, in some cases, life threatening. You mention "medical grade" PMMA. While this may be some comment on the purity or the cleanliness of the product, without FDA supervision you cannot be sure that the material is sterile and suitable for injection. A large portion of the complications seen are related to infections. No matter how "trustworthy" you might feel a doctor is, the material he/she is using is most certainly NOT.
In Miami I see a lot of patients interested in buttock augmentation. I perform a good amount of butt augmentation as well. The technique that I use is fat transfer. It is safe, reliable, and provides a natural result using your own tissue. In cases where there is not enough fat for transfer (rare, though it does occur) implants can be used. Fat transfer is, in my opinion, far superior for natural look and feel.
I hope this info helps!" PMMA is FDA approved in the Artefill form. He cleverly suggests that PMMA isn't FDA approved AT ALL but says so in the context of buttocks injections. He claims a large portion of complications seen are related to infections? Does he really come across that many PMMA patients? He doesn't seem to state so. What studies does he have regarding the high rate of PMMA complication in the buttocks? I certainly doubt the validity of his claim. And it being "life-threatening"? The testing done to get the FDA approval didn't imply any risks of life-threatening complications...so what's the deal here?? |
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Post by Skeptical One on Mar 17, 2011 0:04:11 GMT -5
What is unfortunate is that I'm starting to see a trend...those (doctors) who seem to question the validity of PMMA's safety seem like they have something alternative to sell. Don't get me wrong, there could very well be, and perhaps are some long-term issues that can arise from PMMA injections. But I would love for someone to find a reputable doctor who has the background, experience, data, and reasoning to warrant serious concern regarding PMMA without the strings of commercialism!
I really do, many here are contemplating getting this procedure done, including myself, so I am adamant that any doctor willing to criticize the product/technique offer me more than a handful of complications... Unlike, say the Elist prosthesis... PMMA has been performed thousands of times, and according to one estimate, 200,000 times in South America. If American doctors are only seeing a "handful" of patients, I am inclined to hypothesize that the injection technique could be as much of the problem as any other factor could have been.
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Post by briceb on Mar 17, 2011 0:34:22 GMT -5
Geez, SO. Sounds like you are living up to your name! LOL
I have to agree with you, though. It makes it hard to tell what is the truth and what is "spin" or a criticism turned sales pitch. It really is frustrating.
I think that is why think that forums offering open and honest communication (like MNS) are great.
That was sarcasm, by the way.
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Post by sparticus on Mar 17, 2011 0:34:43 GMT -5
SO
You have brought up a good point about Klein's possible ties to Artefill's competitors. I had wondered if he could have a conflict of interest in temporary fillers. Apparently this is a possibility, good find. I guess we need to address the researchers themselves. Next week I'm going to try to track down the emails for the investigators for the Artefill study and the study that presented migration and size change concerns in guenea pigs. I will share what they tell me with the forum.
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Post by sparticus on Mar 19, 2011 17:30:10 GMT -5
It seems like I am the primary person on the forum looking at studies regarding PMMA. I would like help from other members in finding both positive and negative reports in the scientific literature. We need more information on Bioplasty (New Plastic) as that is the product Dr. C uses. One of the studies I posted had a number of patients that experienced issues from Bioplasty, but no one has addressed whether they have since changed their manufacturing procedure much like the transition from Artecoll to Artefill. So I'm asking the forum to help me look into this (with a focus on Bioplasty/New Plastic pmma).
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Post by hoddle10 on Mar 19, 2011 18:03:37 GMT -5
Do you really believe they changed the carrier in Atrefill for any other reason than to get a patent to distribute it in the US? How on earth could they have made money from it otherwise?
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Post by skatezy777 on Mar 19, 2011 18:16:01 GMT -5
Hi sparticus,
Could you repost exactly those studies you looked at which were specific to Bioplasty/New Plastic PMMA in this thread? That way there is a centralized location and also I know the whole literature you've unearthed so far regarding this particular material and so I won't duplicate.
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Post by sparticus on Mar 19, 2011 18:51:04 GMT -5
Hoddle,
I'm not sure what you mean by your last post. The pmma manufacturing process was retooled from Artecoll through Artefill. I believe part of the reason the process was changed was due to requests made by the FDA in order to receive approval. I do not believe the company that distributes Bioplasty (New Plastic) is the same company that distributes Artefill. I assume each company manufacturers their own pmma, but I may be wrong. If they do not and Bioplasty (New Plastic) and Artefill use the same pmma then I think information found on either can be viewed interchangeably, minus any reactions from the carrier. However, I do not know for certain who is manufacturers the pmma.
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Post by hoddle10 on Mar 19, 2011 19:09:26 GMT -5
You asked if anyone knew if they had changed their manufactuting process in the way Artesmedical did with Artecol to Artefil. But I'm sure I read that side effect rates were pretty much the same. My point was I seriously doubt they changed the maunfacturing process for any other reason than they could patent Artecol and claim they had addressed the issue's previously associated with it. So they change the size and shape of the beads and crucially used a different carrier, so they had a patentabale product. You asked if New Plastic had made changes to address the issues they'd had, in the way Artecol had, but I'm saying the key reason for changes was in order to get the patent and from what i've read, side effect rates seem to be about the same. I think the issue solved were financial and didn't really improve the product.
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Post by sparticus on Mar 19, 2011 19:29:19 GMT -5
Hoddle
I get what you are saying now. With little data its hard to say whether Artefill actually is safer than Artecol, the company claims it is. I think they had the patent before FDA approval, I just think the FDA made the changes conditional in order for the product to get approved. I agree that the changes made were for financial gain and if they had already had FDA approval they probably wouldn't have made them. Can you post the link where you read Artecol and Artefill had the same side effect rates?
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Post by hoddle10 on Mar 19, 2011 19:48:03 GMT -5
The side effect rates are those I've read in the studies posted in the PMMA thread. In fact I seem to remember that Artefill granuloma rates were supposedly less than 0.1%. This sound good, but Artecoll rates were supposedly 1 in 5000.
They may have had the patent prior to FDA approval, but the changes they made to the product of their own taking were done to acquire this patent. Without a patent it would have been utterly poitnless to seek FDA approval. The cost of getting FDA approval is huge, so you aren't going to do this unless you have some sort protection. And they couldn't get a patent for a product as old as Artecoll. Hence the changes, but it's not suprising things like the granuloma rate don't appear to show any signicant difference.
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Post by sparticus on Mar 19, 2011 23:53:10 GMT -5
Well, I have read claims that Artefill has lower rates of granuloma formation than Artefill, but that is from the company itself and those with interests such as Lemperle. I don't know if there is any research to really support whether Artefill has the same or different complication rate than Artecoll.
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Post by Skeptical One on Mar 20, 2011 0:18:50 GMT -5
If the complication rates are in fact under 1% (assuming "if" of course), I'd say that is about as respectable as it gets. The most popular elective surgeries (i.e. breast implants) seem to suffer from much greater complication rates from what I have read from various studies published online.
I'm still having trouble finding in depth info on "New Plastic," but I do know it does not use the bovine carrier and that it is the preferred PMMA by Dr. Casavantes.
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