Has anyone sued Sculptra or the doctor who injected it?

Gry 3 Apr 2013

I am interested in making contact with everyone in the US who already has filed a lawsuit, or in the process of filing a lawsuit or wanting to file. I myself am gathering information, in discussion with the Dept. of Justice (a lot of cover up, collusion and down right fraud) and would like to hear what you are going through. It appears everyone has different symptoms or disfigurement. It has to do with with the mL injected, where, etc. variables. I am interested in understanding as i want to be able to be proactive with my health as i watch it deteriorate every day and the doctors ignore. Also, a lot of lawsuits depending on your circumstances are the federal level and other law firms may be able to help. Please email me directly at Bets0405@gmail.com

sammyandbingo 27 Feb 2013

Hi guys I had nodules under my eyes from a Sculptra mishap from a Dr. whom clearly did not know what she was doing. I did find help THANK GOD, his name is Dr. Shino Bay Aguilera and he is in South Florida, Los Olas Blvd. Very higly regarded Dr. My name is Samantha I hope that you guys all get help becasue I know how devestating it is.

David1962 26 Jan 2013

24 excisions into my hands so far to cut out this stuff! 4 years or more of surgeries. Still growing more lumps. Hands ruined. I only wish we could sue these people!!! I'm in UK.

Dru11 26 Jan 2013

@TinLA, any "Dr" that does not know or understand the foreign body reaction caused by persistent particle injectables, and the complications that are caused by injecting polyester crystals in your face, should not have a license to practice medicine. I am just so disgusted that these "Drs" keep injecting this garbage into people and then act "surprised" to "learn" about these problems that have been documented since it was newfill in the year 2000. They say the "new dilution" and "new injection technique" have almost eliminated the problems. That is another in a long series of LIES they tell. If they want to believe them to sleep at night they should not be "Drs". The product itself has not changed. It is polyester. I do not even wear polyester but it is injected in my face and it is no surprise that my body HATES it. Inflammation, infection, inflammation, infection, granulomas.... Take this crap off the market.

TinLA 26 Jan 2013

Hi Dru11, you are totally right. With about 30minutes of research based on keywords you just wrote above (and I'm sure any doctor injecting sculptra has a rudimentary knowledge of these terms) I found this: http://www.ncbi.nlm.nih.gov/pubmed/16029705 In just a few minutes!! The article was published in 2005!! Clearly showing there is no alternate besides surgical excision in adverse reactive patients (but doesn't link with further studies of the surgery complications or effectiveness). My doctor said "this is the safest thing you can inject. It's suture material and your body will absorb it. It's safer than any other injectables." OMG!

Dru11 27 Jan 2013

I am pretty suspicious of the whole business. They still do not know or claim to not know how long it persists in the body. Why do they stop cutting up the animals sacrificed to science after 2 years when "large remnants" remain microscopically at that point? Why not let some of the creatures live longer to see if it is ever gone microscopically? I was told by a competent physician who does not recommend or use sculptra because he is SMART, that there is a half life to the degradation and the actually gone time is about 10 years if ever. One optimistic Dr told me 5&1/2 years, but I know people who are past that time and still having problems. Where is the accountability? I really just hate the lies. From what I have learned since this torture device was implanted into my facial connective tissue improperly, it is not derived from corn, it is not the same thing as absorbable sutures, it is not a carbohydrate, it is not safe, it causes full body (systemic) inflammation and immune system dysregulation, it is disfiguring, it causes fibrosis and scaring, and is over all NOT WORTH the well documented risks associated. They just change the name and sell it on all the while the FDA is so bloody stupid and unwilling to acknowledge their error in letting this onto the US market by a clever manufacturer using the compassionate expedited approval process for HIV patients. Sanofi had been selling NewFill as a cosmetic device globally since 1999 and it knew of the bad track record it had in immunocompetent individuals. They knew it would be used "off label" and the same result would occur but they never told the FDA and the FDA never googled NewFill to discover its European history. What a bunch of criminals and incompetents. .

Siggie 13 Apr 2013

Dru11, I had sculptra (2 vials) injected 3 weeks ago. I can already see the results. I am scared to death about what might happen to me. So far, everything looks good. I hope it doesn't continue to grow, faster and faster. I like how I look right now. I'd love to join a class action lawsuit, as I appear to be hypersensitive to the stuff My right cheek has a lump on it and the facial nerve is numb.......

Dru11 13 Apr 2013

You will probably be OK. Just do not do it anymore. It may keep growing or it may not. It seems to be very individual.

TinLA 26 Jan 2013

Sorry for the late response, but obviously there are still people being harmed by injections of sculptra into their bodies. I have two hard lumps from sculptra on my jawline and am now worried that they will never go away or that I may develop even more as time goes by. I believe that there are enough people harmed by sculptra to form a class action lawsuit against its makers and distributors. If anyone has begun pursuing this, please let me know as I would like to be added. In my case I don't blame my doctor, who actually did inform me of the possibility of bumps, but not everything about how/why you get the bumps. I truly believe that she doesn't know, as is evidenced by the doctor below who is researching the prolonged and delayed affects of sculptra. I had no idea that the lumps were permanent, that they can recur or that they are caused by an autoimmune response in my body that will last for 55 years when this stuff may (or may not) finally break down! So I'll take this plastic crap in my face to my grave with me. Perfect. At the very least, it be marketed as an implant, as Dru11 has said. Just like the people who had problems with silicone injections that caused permanent disfiguring, sculptra's possible disfiguring side effects will eventually become common knowledge. If anyone is pursuing a lawsuit or can give me more info on treatments, please let me know. Thanks and my support and heartfelt thoughts go out to all others suffering.

PrettyInShockingPink 26 Jul 2012

"Because Health Matters" just not ours.

mia9872 31 May 2012

I did report it to FDA and to Sanofi. Both were very nice about it.

sculptradamage 31 May 2012

Report it to the FDA. Tell the doc he should report it to the mfg and the FDA

sculptradamage 31 May 2012

GP,
the MD is supposed to mix the product 24 hours in advance. You should get a copy of your medical record before he can change it. Go in person and wait while they make you a copy.

Dru11 31 May 2012

Dear Ms.Guineapig,
That oculoplastics dr was supposed to reconstitute the sculptra 24 hrs in advance of injection. So unless he used part of the solution on someone else, there is no way he should have just mixed it up and injected you with it according to the package insert.

sculptradamage 31 May 2012

The lumps do NOT spontaneously resolve.

guineapig 30 May 2012

Well, I have had a few botched cosmetic procedures, in the past, so there must be something seriously wrong with me that I trusted this procedure, thinking it was an innocent filler, without researching the product--especially on this site!. I have been more careful lately about that sort of thing, but was not thinking that day obviously( 3 months ago)! I'm not sure why I decided to trust this oculofacial plastic surgeon after all the rest, when I was actually consulting with him on a botched fat transfer to the eyes which also resulted in a couple of lumps, which is why I was consulting with him and he had mentioned possibly doing kenelog or exicsion but we decided to wait it out and that issue is better thank God, though I will still need an undereye lift due to the misplaced fat. This surgeon seemed more knowledgeable-- of course I thought that about the last ones too.... I had him put restylane under my eyes which didn't do as much as I had hoped for the holowness but at least no problems there. Then somehow he talked me into the overpriced Sculptra, with no literature/video or much info other than his statements that it fills hollows in cheeks and jowl/jaw depressions (which I have lost volume and definition in) and lasts over a year, was not warned about lumps,and of course I didn't think to ask, but was given instructions to massage every day for a few days with arnica to prevent swelling. I was last minute given a consent form, which I didn't even look at very well, I think I had already taken off my glasses getting ready for procedure! Also, as a side note, he was showing a visiting doctor (or student) on the procedures he was doing on me.... He filled upper lower cheeks and jaw line and above mouth, which I think I feel lumps there but they are deeper so not as noticeable (yet). The lumps I just developed in last couple weeks -- 3 months post injection-- are on the jaw line. More on one side than the other and one of them is visible, looks like a pimple or bug bite. and if I touch them, which now that I know they are there I can't stop doing, they hurt a little. Did not get a noticeable positive result from 1 vial of Sculptra, I don't think. I need to see before photos again. Had I even looked at the brochure where it says lumps may occur I might have thought twice! Though in the brochure it sasy they usually resolve on there own, which apparently is a lie. So there you have it. I was hoping I wouldn't let myself continue to be a guineapig, but since I have to get rid of these lumps now, I guess not!!!

trisha333 30 May 2012

guineapig - I would like to know your situation. What part of your face did you have the injections done? Was the doctor who performed the injections, knowledgeable of the product and was he experienced in this procedure? Did he give or show you a video, or any literature about Sculptra before you had it done? With all the negative reviewers on this site (I am NOT one of them) why did you choose to have this done?

TinLA 26 Jan 2013

Umm, trish333...would you please SHUT THE HELL UP??? The people who are following this thread have been GENUINELY HARMED BY SCULPTRA!!! If you haven't, then get the hell off of this thread!! I for one am SICK AND TIRED of clowns like YOU who obviously are PAID by the makers of sculptra to TROLL these sites and make the VICTIMS of sculptra feel like WE did something wrong or the doctors are just inept. Newsflash: doctors are just discovering that sculptra is dangerous themselves. How DARE you come on here and berate all of these people who are suffereing and cause them even MORE harm with your callous, insensitive, self-righteous drivel. If you want to investigate who has been severely harmed by sculptra for your bosses, then do it via courtroom transcripts, NOT HERE! This is for people who want to get together and share their stories of suffering and create a class action lawsuit, not for PAID TROLLS, LIKE YOU.

doesn't look 50 28 Apr 2013

I initially had great results with Sculptra and wrote a glowing review. A year later got more injections. Now I'm dealing with a serious immune response. So she may not be a troll, just someone who's not been affected. I think my response was due to having the sculptra while having reconstructive dental work. Prednisone doesnt control the swelling. I'm told several months course of antibiotics will help. Hopefully. Well people... This is a big problem. I've been 100% healthy and now I am having an immune response where my face is swelling and I have huge lumps in my cheeks. Not going to stay on prednisone. Only the super high does got rid of everything and made me feel normal. If dental work causes this response in some people this needs to be a warning. Class action agsinst the manufacturer? Absolutely, but hopefully I can recover my health because no amount of money would be enough if this product has caused me long term harm. Amazing results? Yes but you risk serious health consequences.

Dru11 28 Apr 2013

I too have serious immune system dysregulation because of sculptra. My teeth are great so based on my experience with this product, the "doctors" who inject it (some not even knowing it is a synthetic polyester and call it natural say it is the same thing as suture it is not) and Sanofi Aventis, I think the whole dental thing is just more smoke and mirrors to put the blame elsewhere. I have great teeth. Had no dental issues and have granulomatous foreign body inflammation that continues 5 years later. I have had several surgeries to remove horrible lumps but smaller ones remain. I have tried to warn others off sculptra for a long time on this site and other sites. Beyond the obvious disfigurement is the systemic sculptra sickness, something I now am calling sculptra consumption because like TB in olden days, it slowly consumes its victims. I saw your initial review. You were just like so many other happy sculptra users who blame the victims for not checking the credentials of the injector, or not following post care instructions just right. The truth is sculptra is very very dangerous. Some people have ended up with cancer (one outcome of a dysregulated immune system). One "doctor" on this site says the complaints are "old news" and with the new dilution and the new techniques they do not have those problems anymore. Another lie. One truth is it is very very difficult to get an attorney to take any of this very seriously. This is because it is very expensive to challenge the pharmaceutical industry and because the FDA considers it a class 3 medical device with PMA approval the supreme court has said the manufacturer is not liable. It is called the FDA defense and it applies to PMA approved medical devices not drugs and not devices that gained access to the market using another avenue. The fact that the PMA was achieved using the trojan horse of "helping poor people with HIV" and it was then marketed off lable to healthy people for which no safety studies where done and for whom it had was used in Europe with poor results and that there was fraud involved could potentially attract some law firm eventually. Regardless, there is ample evidence on pubmed and other sites regarding the problems associated with injectable poly l lactic acid. "Doctors" have an obligation to warn you of these very real and very serious health risks. I am sueing the doctor that injected me with this toxic crap. Steroids and antibiotics did not help and I ended up hospitalized with a very dangerous infection. Had part of my face cut out and still the sculptra remains. I am so darn sick and angry I can not begin to express it. Angry at the drug company, angry at the "doctors" and angry at the happy customers to blame me. I really do believe that the way this stuff works is to mess with your immune system "collagen stimulation" and that it does far more harm then good to anyone. You I hoped I could recover for the first 2 years. Now, I have given up. Prednisone made me very sick also. You can not stay on prednisone and antibiotics for years. my guts are also ruined by the drugs I had to take to stay alive. Sculptra Sucks.

doesn't look 50 29 Apr 2013

Hey... When I researched Sculptra last year there were less of these extreme comments. I also have breast implants and got them after the horrible scare that they too caused a bad immune system response. I have had no health issues with anything before this so I had no reason to think I would have a reaction to Sculptra. I had 2 rounds last year with great results but I was not going through major dental work. Procedures come with risk. Some people choose the wrong doctor. Those are the realities. I believe I have said to make sure you choose a good doc. That is not blaming the victim if something goes wrong. It's just stating the obvious. CHOOSE A GOOD DOCTOR! Sculptra was great last year and this year it has caused me health issues and hopefully I can get some relief. I will remain hopeful. What else is there. I have been affected by health professionals before and lived with my anger and frustration. The anger can be just as debilitating as the sickness. Keep commenting. Be informative so the doctors reading these posts will get info from us and either stop using it or do something to adjust their use. If you let your anger get the best of you, doctors won't be able to see the valuable warnings we are providing. I say to be safe... do not get Sculptra. If you are determined to get it, do not have any major dental work for as long as possible.

Dru11 29 Apr 2013

They are only extreme when they happen to you. I am justifiably angry. I really do hope you recover fully. If stayng away from the dentist is the answer to prevent this then they need to warn people but i doubt that is all that is going on.

Siggie 29 Apr 2013

Hello. I am now 5 weeks post sculptra and have been having lots of swelling for 3 weeks, thinking it is Sculptra overgrowth and looking for Kenalog and 5FU. I believe I'm having some sort of an immune system response. I started taking a medrol dose pack last night and it helped a lot, but the swelling seems to persist. Does anyone have any suggestions on what works or does not work? I hear Biaxim (Clarithromycin 500mg) helps as does Prednison 50 mg for 5 days. Would appreciate feedback. thanks.

doesn't look 50 29 Apr 2013

Yes. Good luck to you. It is very upsetting but try to find peace so you can be effective in getting the message out there. I am definitely informing.

doesn't look 50 29 Apr 2013

I'm searching for the answer too. I'll post if something works for me. Prednisone worked but only when I stay on a high dose. Once the dose tapers off, the swelling comes back. It'd definitely an immune response. I have been told it might be because I had dental work the same time I had the Sculptra because I had Sculptra twice before last year and had great results. I've never hand any health issues or issues with fillers.