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Has anyone sued Sculptra or the doctor who injected it?

  • Burned
  • Hawaii
  • 6 years ago

Sculptra frequently causes permanent, hideous lumps (much worse than granulomas) and Dermik, the company that makes it, is well aware of it. Why then, are there no warnings about this common occurrence in any of their literature or on their website. I'm fuming about this

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There are warnings. Doctor are aware of the warnings, they do not share with you. I have a friend who has a doctor as a very good friend and he searched information on Sculptra. All the doctors can access the database. It has right under "Contradictions warnings/precautions special populations: Women: Safety and efficacy are limited in women with HIV." This is because all of the clinical trials were on men with HIV/AIDs. No women. So to understand, women who had no autoimmune disease were not in any clinical trials and women who had autoimmune disease were not in any clinical trials either. Guess what that means ..... We are the Guinea pigs. And let us not forget PMA was awarded for the self esteem of HIV/AIDs patients. The symptoms that a lot of us have are the exact same symptoms as a person who is HIV positive or AIDS. Therefore, you can believe that during the clinical trials the HIV/AIDs patient could not differentiate their symptoms from an everyday perspective of if Sculptra generated the symptoms. I.e., Fever, inflammation, joint pain, etc. etc. etc.
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Its a French women that came up with Sculptra. I said this is not for regular people as we have an immune system that will attack, been my feeling all along. Shame on them its all about money. I wrote to the company in France but no respond, probably because people there can't read or speak English there. So messed up. I be in peace when they get shut down...
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I thank everyone for the positive comments. I had 2 bottles of Sculptra injected in my own face again about three months ago. My injector is an RN who is nationally recognized as a lecturer in fillers. The product is dissolved for TWO WEEKS prior to injection and small amounts are placed, usually using a 1.0 ml tuberculin syringe. About 0.1 ml is placed in each site. I have watched the product being injected on YOUTUBE and was surprised at the technique. This product must be placed carefully and post injection skin massage is mandatory for 5 days.
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Will the face when its gone go back to normal as it has a memory? Understand the collagen that Sculptra produce is not long lasting, but way the fluid then I wonder some kind of overreaction is that allergy or different?
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That is terrible. My dog can not get surgery without advanced written consent and a sit down explaining all of the risks. There is no protection for people who are manipulated by incompetent plastic surgeons. They are willing to say or do anything to avoid accountability. All plastic surgeons should be treated with the same amount of trust you would give to a used car salesperson. Whatever (s)he recommends first consider how it benefits them. You may be used for purposes other than your own and when mistakes happen you are left hung out to dry. These kinds of Doctors get more for intervening than for not intervening. Then they suggest some simple low risk add on procedures. From my bad experiences stay out of the plastic surgeons office. You can not fix what they have ruined, perhaps improved but damaged nerves and glands and lymph systems can not be successfully repaired. let alone eyelids or blindness.
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I have had an allergic reaction from Sculptra for 2 years. Not only is my face swelling but my throat as well. Seems like this Sculptra can be life threatening for some people.
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Have you seen an allergist? You should be skin tested for a Sculptra alergy. I never heard of an allergy to Sculptra.
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It is quite obvious, Mr. Apesos, that your interest in Sculptra is leading me to believe that Sculptra is your livelihood. As wonderful as that may be for you, many people on this site are damaged and disfigured. Sculptrajunk makes an excellent point. We are not informed the way our dog's veterinarian would inform us of the complications of what could go wrong. A patient's safety should be first and foremost, and if a physician is reluctant to disclose that information due to profit loss, than he/she is in the wrong business. Better find a parking lot and set up shop. Kudos to those physicians, who no longer use Sculptra because it's not worth the risk. They truly have their morals in order.
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No, totally untrue. Sculptra is NOT my livelihood. But real invasive cosmetic surgery is. I do see complications in real cosmetic surgery. But I only hear about the Sculptra problems in this blog. I have NEVER seen the issues you are complaining about. Since I am in Dayton Ohio and no other doctors around here do Sculptra there have thankfully been no problems. If I was in LA or NYC I am sure I would see the complications you are talking about. That is because those doctors should not be using a product they do not understand. I have used Sculptra since the first introduction at least 8 years ago when it was advertised as one bottle for three patients. Today they recommend three bottles for one patient. I think the problem with the company is not really understanding their product and releasing it to unqualified practitioners. I can’t doublet the veracity of the complaints in this blog. I only know my personal knowledge of no problems. Actually no company owns me and I would gladly testify against any bad company. I think the doctors are unqualified even though the patients are fooled into believing they have found the best. No, my practice is not Sculptra because the company does not advertise it enough. BTW its Doctor Apesos!
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Amen
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People get so defensive on here, to bad:( I know what you are saying and it is all how and how much you inject. Don't think the company for Sculptra back then sanofi aventis knows enough about it as I gathered talking to them many times. I have been effected for 4 years, much better but still goes up and down to some degree, even if people don't see it I do. Will it ever stop Dr Apesos you think? I had 7 vials under 2 years and in the one side I got most done on it keeps persisting with fluid. I know it can last up to 5 years and hope to be fully recovered by then. Cant fix it until its over.
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My apologies, Dr. Apesos, in no way did I mean to offend you. Yes, in the big cities it is much more common to see complications because it is being used on a much larger population. Just saying, if the doctors would inform their patients of all the possible risks, and there are many as reported to the FDA, many people would opt out. So many doctors are not disclosing the risks for that reason. Mine sure didn't. My attorney has a lady who had it migrate to her eyes and is now having serious vision issues. This stuff is not a joke!
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Thanks. I believe you are right. I don't understand injecting someone with no consent. I don't know why these complications are not being addressed by the FDA and the company.
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Sadfully, it's all a monetary interest, they could care less how you look or how you feel afterwards. My arrogant p.s. refused to see me, claiming that after 2 years the Sculptra is no longer an issue. Although he was nice enough to invite me to come in for another type of procedure at my expense.
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I don't believe all doctors are this way, some are very compassionate and really do care about their patients. If they make mistakes or if something goes wrong, they will try to correct it. Just wish there were more of them.
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Well, I just completed the medical malpractice trial against James R Miller for injecting sculptra under my eyes while I was unconscious without obtaining written informed consent. He told me it was very safe and told me of no warnings. He told the jury he gave me verbal warnings and obtained verbal consent. He hired an expert Patricia Fox, plastic surgeon to tell the jury that verbal consent is within the standard of care for placing a class 3 medical deice in a persons face specifically where the manufacturer says not to place it. Ethics anyone ???? The jury believed them. My experts said written informed consent was the standard of care but they chose to side with the handsome smooth talking physician who performed a perverse experiment on my face. Shameful.
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These doctors and sculptra makers need to pay. They're gettig rich while people suffer.
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By the way I also have Sculptra in me. But do not inject no in anesthetized people without a permit.
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My attorney said battery would have applied but the statute of limitations is one year and I missed that.
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Dr. Apesos, I wonder if I were your sister, what you think my next steps should be? I am going to fork out the money for the trial transcript. I wanted to file a complaint with the ASPS and the AMA about both physicians. Being an expert witness is considered practicing medicine. I am working with propublica patient harm group to share my experience. I am also working with some other patient safety groups. There were many actions taken that day that were below the standard of care. Do you think the ASPS and the AMA would take this seriously?
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I need to know who was the expert witness for your point of view? Yesm the AMA and especially the ASPS will take you seriously.
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The Juvederm can be removed with an injection of a dissolving solution, and then the Sculptra which is in the wrong place can be isolated and surgically removed.
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He was a prof at Yale med school I PS with a practice and a charitable foundation. Also a subsequent treating PS. I will proceed with the complaint.
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