Write a review

Don't Trust This Stuff - It's Not Even FDA Approved

This product disfigured me, caused lumps, constant...

This product disfigured me, caused lumps, constant inflammation causing pain and distorted appearance, made me physically ill (it is a synthetic) and consequently had very negative effects on my life.  AND, my doctor was a NYC "trainer" for Sculptra.  So, it's NOT about finding the right injector, it's about finding an injector that cares enough about you and your health to not use this product on you.  No one knows the long term effects of this product on the body.  This product has caused allergic rx when used for dissolvable sutures.  Do your research!   The FDA has not even approved this product for cosmetic purposes, and over 50% of the initial test subjects developed adverse effects ala nodules, granulomas, constant inflammation (for years) etc.

I am not alone, there are many people who have been severely harmed by this product.  Please be careful.

Was this review helpful? 8 others found this helpful

Comments (18)

Sort by

Just posted on the FDA MAUDE database is the case of a person who experienced painful inflammation 4 years after injection and the injector states (s)he feels the late onset reaction is directly due to the sculptra. It is not the same thing as resorbable sutures. there are many types of galactic acid. the most crystalline, resistant to hydroloysis (hydrophobic), and long lived in the body is the poly l lactic acid. This is not a "natural" product. There is nothing natural about the way I look with my painful and vigorous immune response to the microparticles my body is attempting to rid itself of but can not so it encapsulates the product. Encapsulated plla is the most difficult to get rid of. I have been told that it takes at least 5 years for the 100% plla to be broken down and absorbed. It make take more like 10 years. So people with health immune systems can and do develop serious adverse events years after injection.
  • Reply
njgirl responds to dusty,s post but didn't realize that it is from dusty,NOT FROM KEITH.I had one treatment of sculptra so far.it has been 4 weeks.I am so scared after reading all the post that daily many times I search for lumps on my face.I think in a sense it is good because if I will develop any lump,I will discover it early and may be able to get rid of it.My heart goes out to the people who develped lumps due to its use.
  • Reply
I have been injecting Sculpra for about 6 years, and fortunately I haven't had any serious complications. I can't speak for the the HIV positive population but the results I have seen (non HIV positive) have been wonderful. Sculptra has lost some popularity in our office due to other long lasting fillers, primarily Radiesse, because it takes multiple applications and delayed gratification since there is not a gel carrier. I have seen only bruising, and papable bb size bumps on occasion, but not a visible lump. Any Sculptra lump can easily be treated/melted with a Kenelog shot, so please don't live with a disfiguring lump and find an experienced injector.
  • Reply
Well now darling Keith... your analogy is not well thought out. The problem is that us non HIV'ers were never told of the risks. Had we been told, we would have never agreed. Doctors use this product out of greed, knowing full well that over 50% of test subjects had adverse effects and that this product is extremely unpredictable and can seriously disfigure and harm their patients. Please check yourself before victimizing the victims.
  • Reply
njgirl, What analogy are you talking about? What is it that I have not thought out well? Are you responding to my posts because you are not making much sense.
  • Reply
Hi Keith, I am sure if you call the main headquarters overseas, they will put you in touch with an injector they trained, now in the US. They can be found in various large territories. You seem like a very smart guy, I am sure you will figure it out and there are probably a few very excellent injectors. As far as being a part of a 'trial study' for the drug company and the injector(s), well unfortunately I already am. I pay for that every day. You will find someone I am sure, do not worry.
  • Reply
I am so glad we learned how to respect each other. Thank you. -K.
  • Reply
http://www.biomedexperts.com/Abstract.bme/12460289/HIV-associated_facial_lipoatrophy "CONCLUSION: Lipodystrophy and lipoatrophy are intimately related to infection with HIV. In consequence, facial lipoatrophy is a major stigma for HIV-infected individuals and can have dramatic effects on their self-esteem and socialization. Effective treatment is essential."
  • Reply
Keith, Please direct me and other people who are non hiv, to "one" only one, HIV website with people harmed by the social stigma of living with the side effects of facial lipo and Sculptra helping them to live 'normally again'. Please. Thank you.
  • Reply
Dear Michelle P, The only HIV website I have ever visited is aidsmeds.com and poz magazine's. I think Butter just replied to your inquiry with a website. I hope my postings haven't made you feel even worse about Sculptra. I felt it was important to let you know that a whole population out there has greatly benefited from this product for many years. I am very sorry to hear about your awful experience and think that maybe we as Sculptra users should share our stories more to find out why I and so many others have done so well with it and others like you haven't. HKKitty made an excellent point that if we were to find out the exact details of each individual case (with the good and the bad results) maybe we could determine the reason why the outcomes are so wildly different. I honestly started posting on this site to find a doctor as gifted and experienced as mine was so I could stay stateside to get my "refills". Dr. Patrick Amard from Paris killed himself in December.
  • Reply
I think you might have just hit the nail on the head. That would explain why this product practically glows in the HIV community and is quickly becoming a monster for the off-label users. (not that you are necessarily told you are an off-label subject at the doc's office) And remember, people like me had moderate to severe facial wasting- Lots of fat loss so our collagen can grow like crazy and our faces never show any over-filling or visible lumps because there is so much fat loss to begin with. Interesting.
  • Reply
I apologize for coming across as a bit condescending but saying "no one knows the long-term effects of this product on the body" is a little bit of a stretch from my and the handful of other HIVer's perspective. Introduced to this product as early as 1999 in studies to find ways to offset the permanent loss of facial fat due to long-term use of HIV meds and possibly just having full blown AIDS for a while in the mid- 90's while waiting for the powerful protease combo to save us. Fortunately many of us made it out alive but with disfigured faces , no ass, skinny, veiny arms and legs and a buffalo hump so they can stare a your back from the side. Careful liposuction on a couple parts of my body was able to resolve the back and neck fat but my face had lost more than 60% of fat volume. New-fill was administered by Dr. Patrick Amard and started seeing t work after the third visit (over 7 months) positive increase in facial volume at the precise area of lipoatropy. Since 2001 have had over 14 deep injection sessions with no visible lumps or nodules. I am NOT suggesting people to ignore the negative posts on Sculptra. On the contrary, we all have to collectively share our individual experiences to better understand the weaknesses and strengths of using it. I makes my heart heavy to discover after all my years of happiness with this product how devestating Sculptra can be for so many people.
  • Reply
Hey Keith... here is your new lesson for the day..LOL No but really this might be helpful for you and others to better understand what is going on here in regards to the problems with Sculptra... Understanding the nature of Poly-L-Lactic Acid (PLLA) - AKA sculptra, is important.... The immune system has an integral role in fibroblast behavior, (that'd be the lumps/granulomas) in other words its how the the host immune system responds to it. Poly-L-lactic acid differs from the other fillers in that it is dependent on the host immune/reparative response to accomplish filling. Other similar products include silicone and polymethyl-metracrylate (neither is currently FDA approved for soft tissue augmentation). Here is the risk factor: and there is no way even the best injector in the world can control this.... Unfortunately this mechanism of action for augmentation has two potentially negative effects INHERENT TO THE NATURE OF THE RESPONSE : (1) the host immune system can respond less than optimally causing less augmentation then desired; or (2) the host immune system can respond over exuberantly creating granulomas or lumps. I repeat.... INHERENT TO THE NATURE OF THE RESPONSE In the medical literature, there are many reports of delayed foreign body granulomas; in one report with PMMA (Artefill/Artecoll, which is Plexiglas!), up to 12 or 13 years following the injections! The reasons this can occur is that you are injecting something foreign into your body and the human body has a very sophisticated immune response. When it sees something as a foreign invader, it creates a complex reaction to try to get rid of it, and the result is the granuloma which you describe. Your best injectors have no control over this !!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!! So if your injector is injecting this stuff for cosmetic purposes- he/she is not the best! Its just criminal to take money and cause this kinda of harm. and this is the point the injector will blame you for the problem - Pretty good racket they have going! Lastly... The immune system has an intergral role in fibroblast behavior so the response to this product in the immune-competent population might be quite different to that of the immunocompromised population. Best Regards, Kooie kooie
  • Reply
Keith, I cannot believe all these people who are putting down a COSMETIC treatment. Should they not question their own integrity and want to become young looking instead of blasting the available treatments for people like themselves! I completely empathise with you and I have known alot of people who have undertook treatments in Sculptra and one way or another changed their lives for the better!! Bottom line If you don't want the treatment then don't have it! Put the effort it takes into slamming something that has a proven history of working into building your own confidence when you look in the mirror! Remember cosmetic surgery is a choice not a necessitiy and if you are not prepared to take risks then don't do it!!! Just a last thought for those of you with such enthusiasm about side effects Next time you go to take a paracetamol try reading through the whole info leaflet including the possible death part and I bet you still pop that tablet in your mouth! All the best to you Keith
  • Reply
You sound hysterical. Sculptra (New-fill) has been used in Europe for over a decade. I have been getting poked with it over 14 times since 2001. I think the FDA approved it in 2005 or something but I still go to Paris every six months for touch-ups. HIV+ for 25 years. Zerit(d4t)cased moderate to severe facial lypoatrophy in 2001, this 39 year old looked 50, Now approaching 47 I look 39. I want to see the HIVers out there tell me about their experiences. I'm wondering if this prduct has more complications with those that do NOT have HIV med-related lipoatrophy.
  • Reply
I'm disappointed by your "you sound hysterical". My experience is not unlike many others who have been given this product for very minor facial thinning. I hardly had a wrinkle on my face when this was sold to me as a simple"collagen booster". I was never told that it is an implant, an aggressive product that can cause many of the adverse effects I have suffered. It's disturbing to me that many still promote this product as "FDA approved", leaving out the necessary information that this FDA approval is NOT applicable for cosmetic usage. My goal is to help others get the information they need, the information that I was not given by a very greedy doctor and the drug co. that funds him to "train" others to use this product carelessly off-label.
  • Reply
Oh my gosh. Sounds bad. 2 things that would be really helpfl: 1) who was your doctor? 2) do you have pics you can show? i know real self let's you edit your posting to add info like this.
  • Reply
Hi there More: I'm not sure what you mean by "would be helpful"?? I am happy to help whomever I can but don't understand why a copy of my pics and the name of my doc will be helpful to you.
  • Reply