arnioldkleinmd
Dermatologist
beverly Hills, CA United States
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Sculptra a disaster !
March 28, 2012 12:36 AM
The filler Sculptra was at one time considered an important agent in managing facial fat loss in HIV+ patients. Prior to FDA approval, it was used in a clandestine manner. In clinical
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The filler Sculptra was at one time considered an important agent in managing facial fat loss in HIV+ patients. Prior to FDA approval, it was used in a clandestine manner. In clinical trials evaluating this agent for correction of fat loss in HIV+ patients although the study patients were for the most part satisfied, up to 50% of the injected individuals developed some degree of lumpiness in the treated areas. Furthermore, these lumps are often far from invisible. Nevertheless, Sculptra® received rapid track compassionate release approval from the FDA for use in patients with HIV. The panelists on the General and Plastic Surgery Device panel were strongly unanimous in limiting approval only for patients with HIV. At the FDA hearing, not one histologic slide showing the fate of Sculptra upon implantation was shown. Again, how can an agent gain approval without scientific data supporting its application?
According to the European literature the consequences of Sculptra® in the normal host has been very problematic (foreign body granulomas, infections, etc.)
Here is a photograph of a patient who came to me who had an adverse reaction to Sculptra®. Frequently the only way to get rid of these lumpy ridges is to excise (cut out) them from the face.
Nevertheless, the lay press, medical conferences and internet began to promote this substance for soft tissue augmentation in HIV negative patients. Although prospective studies for the use of this agent in individuals with normal immune functioning had not yet been completed in the United States, we did have reports of the European experience.
In 2000, at the World Congress of Dermatology in Paris, Pierre Andre reported cystic, nodular, and granulomatous lesions when this agent was used in individuals with normal immune functioning (non-HIV+ patients). Additionally, long-term allergic reactions have since been described, which are very difficult to manage. In another report concerning its aesthetic use in 100 patients with normal immune functioning, 20% of the treated individuals experienced significant adverse reactions. Obviously, this product is not immunologically inert as the manufacturer stated. Foreign body granulomas are being seen with this agent in HIV-positive as well as immunocompetent patients.
While the manufacturer as well as investigators claim this product produces neocollagenesis or new collagen this is not what is seen under the microscope. On biopsy one sees a severe immune reaction to the product. Now this product has been approved for immunocompetent people and every day i see or am called about lumps. These are an immune reaction and should not be cut out. Find a doctor who knows what he is doing and these lumps respond to intralesional injections of 5fu and Kenalog.
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klausmikalson
March 29, 2018 10:49 PM
Many of the Kodi add-ons have already been removed or blocked by the authority, because of providing illegal access to certain paid media. Here are the list of some best kodi addons which are still working.
https://crumbles.co/best-kodi-add-ons/
francim
Tampa, FL
United States
June 4, 2013 11:58 AM
Yes, I too was injected by a reputable plastic surgeon and my face is a mess of inflammation. I have huge nodules in the center of both cheeks. Not tiny nodules but huge 1-1.5" nodules. I had 2 rounds of injections last year with great results.
letty65
March 26, 2013 7:03 AM
I am about a year out from Sculptra, and have lost very little volume at this point in time. I also suffer from daily burning and swelling with no relief. I have just recently discovered if I take chewable vitamin C 3 to 4 times a day it calms the inflammation and the swelling goes down. Hope this helps a bit.
sculptradamage
Feura Bush, NY
United States
January 6, 2013 9:18 AM
It is NOT GONE in 2 years. The literature says degradation is greater then 24 months. But they do not say when. My opthamologist says it may be 10 years or more. I object to the "doctors" that criticize Dr Kein for his informed honesty while they cling to what the sales rep with an associates degree told them in the sales pitch they received. I know it shows in my biopsy at 3 years so anyone who says it is gone in 2 has their head where the sun don't shine. FYI. Note Sculptra is Poly L lactic acid. http://www.fda.gov/downloads/MedicalDevices/NewsEvents/WorkshopsConferences/UCM329321.pdf page 6. says PLA >24 months. meaning it is still there after 2 years. Granted it was injected wrong into me by a board certified PS, but lets face it these guys are so arrogant they need not bother reading instructions.
This review is focused on how these polymers may be synthesized to yield different physical and
mechanical properties as well as degradation times. An example is by adjusting the molar ratio of
lactide to glycolide, poly(DL-lactide-co-glycolide) (DLPLG) polymers may be synthesized with
degradation times that vary from weeks to months. Table 1 gives a partial listing of key physical and
mechanical properties including degradation time for select polymers.
This review is focused on how these polymers may be synthesized to yield different physical and
mechanical properties as well as degradation times. An example is by adjusting the molar ratio of
lactide to glycolide, poly(DL-lactide-co-glycolide) (DLPLG) polymers may be synthesized with
degradation times that vary from weeks to months. Table 1 gives a partial listing of key physical and
mechanical properties including degradation time for select polymers.
litsasynesi
April 25, 2012 5:56 AM
Hi there,
I am so sorry to hear your experience and really wish you will get better soon!
I work for Maverick Television (The producer of Embarrassing Bodies and How to Look Good Naked)in London and we are looking for people just like you, who have suffered from a cosmetic surgery procedure. We are hoping to speak to people ASAP this week with the potential to appear on a new TV show which offers the chance to correct these awful procedure.
We would love to hear from you. Feel free to call on 0207 874 6622 or get in contact via email l.synesi@mavericktv.co.uk.
Hope to hear from you soon.
All the best,
Litsa Synesi