The last two circles of Hell punish sins that involve conscious fraud or treachery. The circles can be reached only by descending a vast cliff, which Dante and Virgil do on the back of Geryon, a winged monster represented by Dante as having the face of an honest man and a body that ends in a scorpion-like stinger (Canto XVII).

Bolgia Ten: Falsifiers, those who attempted to alter things through lies or alchemy, or those who tried to pass off false things as real things, such as counterfeiters of coins, are punished here. This bolgia has four subdivisions where specific classes of falsifiers (alchemists, impostors, counterfeiters, and liars) endure different degrees of punishment.

“Just because something isn't a lie does not mean that it isn't deceptive. A liar knows that he is a liar, but one who speaks mere portions of truth in order to deceive is a craftsman of destruction.” 
― Criss Jami

Sculptra Damage

SculptraDamage@gmail.com (me) has received many emails from people who have had all varieties of complications from this product.  Please avoid this product and if you have already had complications from it, please report those complications to the FDA and the manufacturer.  Do not expect them to care or be of any assistance but it is important to report these all too common problems.

I have no answers

There is no help for complications from the misuse of this product.  We are just screwed up now.  Our immune systems are screwed up. Thanks Dr for suggesting this product be used on me.  You described it as "very safe".  I can not get back my face, my health or the facets of my life that are now only a memory.  You Suck.

Someone is Finally Listening to Sculptra Damage

The FDA provided me with some of the redacted information.  There were over 700 scuptra product technical complaints received by Sanofi during a two year period prior to obtaining the FDA cosmetic use approval.  Sanofi reported zero of those events to the FDA as is required by law.  With their multinational staff and multi level review they were confuse about what was reportable.  Had they reported adverse events as required many of us may not have been harmed.  If you look at the FDA maude database for adverse event reporting, Sanofi has a "new decision tree" for determining if something is reportable.  Since the beginning of 2010 there have been about 40 new reports of "serious adverse events" using this new decision logic.  This Sculptra Damage did not need to happen to us. If you were harmed by this dangerous and unpredictable product to to www.sculptradamage.com there is information on how to report your situation to both the manufacturer and the FDA.

FDA compliance inspection shows Sanofi Adventis failed to report serious adverse events to the FDA

There is much redacted information.

Through Freedom of Information, I was provided with an FDA inspection document FEI 3000719690. This is a compliance inspection report. I cant help but wonder, had Sanofi reported adverse events as required, perhaps the FDA would have required more stringent label warnings and marketing precautions and I might not have been harmed. It is interesting to me that the FDA officials documented that during the time period evaluated by inspectors, 08/20/2007 – 07/31/2009, the only Sculptra adverse events reported to the FDA were not from Sanofi Adventis. The FDA had 4 reports made directly to them, of which one is mine, two are from non-mandatory reporting physicians and one from a sales representative. It is interesting that during this inspection it was discovered that (redacted number) of Product Technical Complaints were reported to the company. The FDA investigators reviewed a random 33 of those (larger number redacted) complaints and found it objectionable that many of these adverse events were not reported to the FDA as required under the terms of P030050 and its subsequent versions. In fact Sanofi Adventis reported zero adverse events to the FDA. Reportedly, Sanofi Adventis, a very well staffed knowledgeable multi national drug company was “confused” about what is and is not reporting criteria. I am sure that the wider marketing strategy did not include reporting adverse events so claiming to be ignorant of reporting criteria helps until the larger market approval is achieved.

The large inflammatory granulomatous nodules I am experiencing are certainly not "papules" described to the FDA during the hearings. Furthermore I am not alone. Many people have had serious adverse events from Newfill or Sculptra or Sculptra Aesthetic.

I was told "its the same thing that is used in absorbable sutures". Now I have learned that is NOT TRUE. Sutures are a more amorphous form of poly lactic acid which is intended to dissolve. The 100% poly l lactic acid product used in my face is a crystalline form. The company will not tell me how long it stays in my body. From what I have learned, it could be more then 5 years!! With the clumping that took place in my case it could be far longer. How Dare they Lie to the FDA and Lie to me. I am going to be meeting with both Congressman Tonko and Senator Gillebrant to request further intervention. If the company failed to comply with the terms set forth it should be removed from the market until adequate non Sanofi sponsored safety data is available.

www.sculptradamage.com all updated

Because of endless litigation I have put the website on hold.  When everything is over I will share with people the process of litigation and how messed up it is.  The web site www.sculptradamage.com was created by a few of us who have had very very bad experiences with the product Sculptra. It has a reading room that provides detailed information on immune system foreign body response and medical and scientific information. It provides information on a few people who have been harmed and offers a forum area for people to post. I must say when someone tells me how great the stuff is, I am very glad they are still OK. Anyone who continues to use this unpredictable product should really look into the literature provided and the experience of people in other countries. New-Fill is no longer legal in some countries where it caused so many problems. I guess it will take someone really important like Tyra Banks or Oprah to get sick from this product before anyone really takes it seriously.

The mess that sculptra has made of my life

I have not updated this site for a while. I have been pretty depressed. I had surgery to remove hardware from a 1992 injury. The Sculptra BIOFILM infection spread to the other parts of my right eye. I am going to need 2 more surgeries on the right and the left just looks awful. I did manage to get the www.sculptradamage.com website updated. Please have a look.

Sculptra Biofilm Viridans Streptococci Group

The Culture reports heavy growth of this Viridans Streptococci Group Biofilm

sculptra implant biofilm diognosis

Today I went to the opthalmic plastic surgeon. I had two exploding face infections since the surgery to debulk in April. I have been told, all we can do is try to keep on top of infections and wait for the sculptra to fully metabolize. For those who dont know, Sculptra microspheres do not metabolize and go away for a full 3 years, minimally. Most plastic surgeons say that the cosmetic result lasts for about 2 years, but they dont tell you - that for those of us whose bodies have decided the microspheres are our enemy, and continue to form granulomatous inflammatory tissue in response to it, we unlucky few, will continue to have reactions until it is gone. So I had a horrible infection that actually exploded through the skin in 4 locations (it is being cultured. I write this a week later and i still have an open wound that has not closed. A biofilm is an A typical bacterial (or other type) of infection that has attached itself to the implant. Remember sculptra is considered an implant. I gave up and am out on disability at half pay. A 23 year career is ruined. My pension will be almost cut in half if I can get disability retirement. Sculptra Sucks Ass.

e-mail from the UK on Sculptra granulomas

This is an email sent to me from a woman in the U.K. in May 2009
I am posting it here to share with you just how widely spread the harm from Sculptra is. It is anyplace the product is sold to people foolishly trusting a multi national drug company.


Getting Sculptra was the biggest mistake of my life. I want to caution everyone thinking of having this stuff injected to do your research before. Most ethical doctors don't use this product anymore. Very risky and it doesn't help to have a master injector, even he or she can't control who gets granulomas and who doesn't. Its been a major problem here in the UK too.

from the Netherlands

last night I was emailed by woman in the Netherlands. I wanted to post this on the blog

Hello my name is Dia..and I'm from the Netherlands..
Someone placed a link to your website on the "Miss J" forum..And I saw your pictures..What can I say............can't even say I feel sorry for you..because that's is not enough.. In 2002 I had injection with New Fill.. and it became bumps...But..how lucky I was..I could only feel them..you could not see them..It took 3 years...before they were gone... But..here in Holland..there is a lady called Silvya Veerman..She also was injected with some kind of stuf..and became deformed..She wrote a book abouth it..and she has founded a "place" for people who are "misformed" byinjectors and P.S.I give the link to her web-site..it's in dutch..but you can see her picture..You can contact her..maybe you can work together...and..maybe moreimportant..she found here in Holland a P.S..and he did nice "repair"-job..http://www.legaalverminkt.nl/index.htm Hope this helps a little..I feel soooooooooooo sorry for you....but that's not helping much...I think..Sorry for my english writhing..;-))I hope you do contact Silvya..and if you have the money...you contact her P.S.special the lady who showed her eyes ... all the best for you.. keind regardsDia

I thank you Dia for this useful information. I used the google translator to translate the web page at the link above. Sylvia did email me and I have reponded to her. Thank you fine Dutch people for your heartfelt concern. Love to you and your beautiful country.

sculptra is a never ending problem

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