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TOPIC: Summary Interim Results of FDA Mandated 5 year Artefill Study

Summary Interim Results of FDA Mandated 5 year Artefill Study 11 years 4 months ago #1269453878

Total of 1008 patients, mean of 2.5cc injected per patient. 18 months: 7% device related adverse effects, 4 lesions, 1 granuloma which was treated successfully. www.aesthetictrends.com/monthly_updates/...0ArtefillFINAL.pdf36 months: 11% device related adverse effects, 11 lesions, 1 foreign body reaction, 6 granulomas, 5 treated successfully, 1 still undergoing treatment. infoviewer.biz/infodisplay/story/imn0708...l?APP=7&CU=imn5804My take: low rate of serious adverse effects at 0.59% but note the increasing number of late onset granulomas. Only 1 at 18 months after injection raising to 6 at 36 months after injection.Initial 145 people 5 year study: 8% device adverse effect, 2 granulomas 1 had to be cut out, 1 partially responded, 10 cases of lumpiness, 2 cases persistent swelling or rednesshttp://atsh.co.ir/Catalogs/articles/Aphrodite%20Gold%20Artesense/Five%20years%20study.pdf

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Summary Interim Results of FDA Mandated 5 year Artefill Study 11 years 4 months ago #1269457758

openraptor wrote: True.
I was posing a rhetorical question though. I was trying to get at what differences in outcomes and adverse effects would we see or not see when PMMA is injected into the penis. It is obviously being placed in an area which experiences greater stress. How will it hold up or react? And the bottom line is we don\'t know. Long-term trials are needed to evaluate this. And what happens if there is an issue that needs treatment, where do we go? What happens if Dr. C goes out of business or retires? Can we goto a Dermatologist or plastic surgeon that will be able to fix it?
All questions we must be cognizant of and we must be able to sleep peacefully at night not knowing the answers to these questions before and after the procedure.

Very important questions.
My presumption is that PMMA will trend in the future, especially if studies are consistent with the above Artefill reports, leading to an increase in the number of qualified physicians who inject PMMA and treat issues that result from PMMA complication.

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Summary Interim Results of FDA Mandated 5 year Artefill Study 11 years 4 months ago #1269457726

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True.
I was posing a rhetorical question though. I was trying to get at what differences in outcomes and adverse effects would we see or not see when PMMA is injected into the penis. It is obviously being placed in an area which experiences greater stress. How will it hold up or react? And the bottom line is we don\'t know. Long-term trials are needed to evaluate this. And what happens if there is an issue that needs treatment, where do we go? What happens if Dr. C goes out of business or retires? Can we goto a Dermatologist or plastic surgeon that will be able to fix it?
All questions we must be cognizant of and we must be able to sleep peacefully at night not knowing the answers to these questions before and after the procedure.

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Summary Interim Results of FDA Mandated 5 year Artefill Study 11 years 4 months ago #1269456098

openraptor wrote: These studies are positive regarding nasolabial folds.
How would they differ if they were measuring PMMA used in the penis?

Well for starters, the mean injection of PMMA was at about 2.5 for the above study, whereas patients on this forum who have had PMMA in their penis would have had a mean closer to 30cc +. So a significant difference in the amount of PMMA would certainly be a major differing factor.

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Summary Interim Results of FDA Mandated 5 year Artefill Study 11 years 4 months ago #1269455658

EQ
What is your take on the late developing redness and swelling? To me that sounds possibly indicative of a local chronic inflammatory response. If that is the case, I would be concerned about the long term effect that would have on the surrounding tissue.

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Summary Interim Results of FDA Mandated 5 year Artefill Study 11 years 4 months ago #1269455604

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These studies are positive regarding nasolabial folds.
How would they differ if they were measuring PMMA used in the penis?

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Summary Interim Results of FDA Mandated 5 year Artefill Study 11 years 4 months ago #1269455514

@S.O. ' in these kinds of studies device refers to the actual product so the injected Artefill is considered a device much like prosthesis or breast implant is considered a device.I agree that these are clear and very encouraging results. I would caution everyone to read the summaries and then the detailed reports. Please note that at 36 months > 1 of 10 participants did experience some adverse events such as lumpiness, redness and swelling. This was an increase from the 7% at 18 months.

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Summary Interim Results of FDA Mandated 5 year Artefill Study 11 years 4 months ago #1269454616

@EQ
I\'ve read through both articles but couldn\'t figure out their exact definition of \"Device-related,\" - do you know what they mean by this specifically?

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Summary Interim Results of FDA Mandated 5 year Artefill Study 11 years 4 months ago #1269454533

Granted, this isn\'t New Plastic, nor is it likely that it was used heavily (or at all) in the penis, but it certainly suggests that the use of quality medical-grade PMMA is pretty safe, relatively speaking.
6 granulomas out of 1008 patients, 5 which were treated successfully, with only 1 granuloma facing ongoing treatment. I\'d say that\'s pretty darn good considering how adamant Dr. C\'s office has been about its rarity. Of course, now we have to hope New Plastic can obtain similar analysis since it may be a while until Artefill is cost-effective for Girth enhancement.
Great links EQ!

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Summary Interim Results of FDA Mandated 5 year Artefill Study 11 years 4 months ago #1269468030

sparticus wrote: EQ
What is your take on the late developing redness and swelling? To me that sounds possibly indicative of a local chronic inflammatory response. If that is the case, I would be concerned about the long term effect that would have on the surrounding tissue.

I am embarrassed to say that I have not gone after the more detailed study analysis because I did not see anything interesting other than the fact that 5 more granulomas appeared at 36 months. Your suggested diagnosis, if verified, would certainly be cause for concern. The study team did not make that call so we will see if that changes at the 48 month interim report.

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