Several months after I had two sculptra injections in my face, I started getting large painful bumps. I also have inflammation and nerve pain. Does this ever end?
That is my picture on this blog site. I had sculptra injected and was never given warnings that problems could persist for years. I was told the standard, its the same material that is used in absorbable sutures. It has been in use in Europe for over a decade. There may be some blood or papules at the injection site. Does that statement indicate to you that 14 months later you would have enormous painful granulomas as shown in thise picture? Some people in this "club" have granulomas 4 years later. I had such damage that granulomatous tissue was pressing on my eye ball and rectus muscles as confirmed by a CT scan. My vision in the right eye had gone all blurry. Both sides continue to react with regular painful flare ups to what i was told was an "inert" "biocompatable" filler. When I was in crisis 3 months after injection, no Doctor would touch me. The standard response was you have to return to the BOZO board certified plastic surgeon who did this to you. But he moved to another state! Finally a good doctor took pity on me. I had surgery on the right eye, mostly to save my vision. I have been on and off steroids for over a year and a half and nobody has any answers. the surgery to remove as much of this crap as possible (not all) ended up distorting my lower lid so it is all droopy... Looks like I will need MORE corrective surgery. This has been an assault on my face. The lumps and pain dont seem to go away. What a horror this product has caused me.
I will just recap what I hope this Esteemed PHD did not say at the Nov. 08 FDA Medical Device Advisory Conference, Dermal Fillers:
"The patients have already voted for the Procedure. They're coming in with lots of Money in hand and have Voted for the Procedure." Now to me, I'm not an esteemed PHD, but that person seems to have an agenda and not patient safety. That is my Vote.
Wrong Dr.. The Patients are not being informed. No woman in her right mind if properly informed of the risks associated with these semi permanent and permanent dermal fillers would agree. We are being sales pitched, marketed to in office and mislead by the Dr. Madoff's; The boys the Big Drug Companies just love to send their reps to meet. Just place those bogus brochures right there where she can't miss it, those woman will never know the Photos of results are not attainable with just injections. Please. Just think dr. you can make $2000 for one hour of injecting this stuff, not bad.
Who invited this guy??? The Drug Companies or the Physicians for Injectable Safety Counsel?
Having this type of input at this particular conference on Dermal Fillers, while woman are being mislead and harmed by MDs is insane and exact reason woman will keep on being harmed. No, I walked in as a patient assuming (my fault I guess) the title of MD of this board certified plastic surgeon's door at very least, I wasn't be mislead by Dr. Madoff. So yes the drug companies will continue to profit and the Dr. Madoff's will continue to harm woman and blame the patient. There are no rules when you walk into the door for a cosmetic consultation. It is your fault. It was who t their trust to because of this titleat title.e Conference, who scheduled this guy to be a part of this? The big drug companies or the Doctors for Injectable Safety?
I am up at 4:30 in the morning, oh yes just felt more Sculptra horror in my eye area and now a lump of this garbage is affixed to the bone under both of my eyes. Guess I wasn't deformed enough.
Do plastic surgeons actually take facial anatomy classes, or just practice on female patients?
Oopps, I just went too close to her eye with a needle full of diluted suture material, well not sure I got that mixture right, I better read that part next time. What is she gonna do to me anyway? I got the best lawyer in town. Let's see, can he say her blindness was due to a pre existing condition? Yeah.
I had my third sculptra injection yesterday. While I was getting injected I noticed my eyesight became blurred. The doctor had me shut my eyes and continued the injections. Afterwards I opened my eyes hoping that the burryness was gone and it was just temporary. It is not. 24+ hours later I still am unable to see clearly. I have an eye patch on, have pain in my eye and I have seen a specialist for eye problems. They believe the injection got in around my eye and is causing pressure which is causing me to basically have a lazy eye. They "hope" that it will reverse itself within a week. I am beyond upset if you can imagine. I am scared my eyesight will not recover and I am sitting here for a week not being able to do anything. I can't drive, I can't go to work, and I can barely keep my good eye open because it makes my bad eye hurt to have it move at all. I wish I had never done this. It is not worth losing my eyesight.
I am so sorry to read about the above poster who is having to deal with blurry eye problems. It brings me back to when this first happened to me. Scary and hiding out in the house is exactly how it was for me and still is. Everyday you will jump out of bed hoping the problem is better or gone. I am keeping my fingers crossed that this will heal and you'll be normal. I truly believe this will clear up. The solution they use today is not as concentrated as it was when it first hit the market. Give it some more time... But if its getting worse you should see the eye doctor again. or a different eye specialist. The final kicker is we had to pay for this on top of being injured... The doctors aren't responsible and its just not right. I am hoping the best for you. Keep us posted.
Please email me with your address and we can try to help you out. be sure to report this event to the FDA. reporting information can be found on the www.sculptradamage.com website in the reading room under FDA information. please email me directly at sculptradamage@gmail.com We hope you are going to be ok. it is very important to report this to the FDA and to the company. Thank You
I very trustingly had Sculptra injections a year ago. 2 months ago my face started to itch really bad, then the lumps started and have got progressively worse ever since. The "doctor" who done this is sending me to a specialist of course claiming that I had an underlying autoimmune disease to start off with. I asked why I wasnt warned of this possibility and she said it was so rare to have a reaction that it wasnt worth mentioning. After having extreme low self esteem and depression after a long term relationship breakdown this is devastating for me, I AM VERY ANGRY. Is it worth my while to seek legal advice? I live in Australia.
Dear Jillian, I also "now" of course, only AFTER Sculptra injections have several symptoms of an autoimmune disorder. I was extremely healthy before these injections, no more. All of these horrid symtoms were the results of Sculptra injections and the Drug Company getting these toxic pellets into the hands of any Dermo or Board Certied Plastic Surgeon. Whoever graduated from medical school with a speciality in either of the two who and will risk patient safety for money.
Thank you for acknowledging my comments, I hope you are OK, meaning inside yourself. I am still tossing up about getting legal advise, has anyone sucessfully done it yet? Jillian
Hi Jillian, If you email me at sculptradamage@gmail.com I can email you directly. Yes, I am as OK as anyone can be in this awful situation, meaning my face is all messed up because some plastic surgeon got creative and decided to practice on my face. opps he needs more practice. We have a law firm that is looking into both the physician and the product liability issues. We can only hope for the word to get out so that others are not harmed. We trust that doctors will do the right thing by us and that is not the case so often. unfortunately they do not disclose the true hazards a procedure or device offer. instead they tell us it is safe and bad things dont happen when they do it... again opps so sorry i messed up your face and your entire life. Next.
Dear Jullian, Please remember the person who is organizing this website obviouly is very sick from these injections of a very risky Dermal Filler. I have the constant attacks of nerve pain, confusion and instense attacks of disfigurement from the systemic diseases a "doctor" created / triggered in me. Of course, no warning of the risks. I never in a million years if informed allowed this dr. who made a huge profit to Inject. Being in a very similar situation, a living nightmare I can wake from, I can't even begin to do what she was done. I hope you are beginning to feel a little better. With time most of us very harmed have not recovered. Not what you want to hear, but I continue to develop more "late on" symptoms of diseases with time.
Keep us updated on your condition. Remember also you can report the surgeon or dermo who did this to you to The Office of Professional Medical Contact. Please do.
Hello to all of you going through this thing same as me. Just when I think its a bit better it all flairs up again. Just got bills today for in depth blood tests taken!!! F..k what now. Jillian Stuart.
I have had temporary fillers, juvederm for the last few years and have been fairly pleased with the results. I have heard a lot of the wonders of sculptra and was interested to learn more. I googled it a bit more today and a found links to your page. I certainly wont consider having it done now. I will stick with my temporary fillers.
It seems to ne this is a time bomb youve hit on. It will eventually come out. I guess all you can do is keep arguing your cause. Make the most of sites like youtube, lots of people watch it!
I wanted to make sure you all saw this by Dr. Arnold Klein who is speaking out for the good of the people.
CNN Larry King's illuminating Dr. Arnold Klein interview VIDEO ... Jul 9, 2009 ... Tonight on CNN s Larry King show, Dr. Arnold Klein revealed some interesting ... "The FDA is run by the drug companies," shared Klein. ... www.monstersandcritics.com/.../CNN_Larry_Kings_illuminating_Dr._Arnold _Klein_interview_VIDEO - Cached - Similar
May 1, 2009 ... The FDA is also requiring manufacturers to send doctors a letter warning of the risk. ... used their positions to develop fiscal ties with pharmaceutical companies. ... These same doctors run medical societies, edit and advise trade ...
Arnold William Klein, MD. Professor of Dermatology and Medicine ... blog.newsweek.com/blogs/labnotes/.../botox-warning.aspx - Cached - Similar
Over the years, I have watched the profession of medicine be severely abused by doctors in high level political positions who’ve used their positions to develop fiscal ties with pharmaceutical companies. The FDA, medical societies, continuing medical education organizations, and physicians (once distinguishable entities) have so enmeshed themselves with pharmaceutical companies that it is all but impossible to see where one begins and the other ends. Physicians supported by these companies promote their products, not only to other doctors but to the public as well (and in many cases, despite proven evidence of the safety of the product or products). These same doctors run medical societies, edit and advise trade publications, appear on the Internet and television, and speak before the FDA. They conduct the studies and write the papers necessary for FDA approval—papers published in leading medical journals that often contain inaccurate data. The public should be alarmed and changes in the pharmaceutical industry and the FDA need to happen immediately. Somehow and in some way, I must warn the public of the potential danger that exists at the end of the needle. The next innocent person to be exposed to this danger could be you. If you are reading this, please help me spread the word.
Arnold William Klein, MD Professor of Dermatology and Medicine David Geffen School of Medicine at UCLA Arnold Klein Chair in Dermatology at UCLA Report Abuse
An article on other fillers: Scupltra is just one but there are others causing problems such as: Radiesse (formerly known as Radiance, silicone, artefill (formerly known as artecoll) dermalogen & cymetra (both made from pooled cadavers (deceased people), both which are known to risk diseases such as prion CJD disease.
Space did not allow me to post the entire article, so I suggest you look it up & read it yourself. I have included parts of it only:
Exploring the Evolution of the Injectable Filler Industry and the Consequent Implications for Regulatory Action
Angela Esther Kim Class of 2006 Food and Drug Law 3L Paper Professor Peter Barton Hutt May 19, 2006
Abstract: Although the American pursuit of youth and beauty has long influenced female consumers, the recent introduction of injectable fillers has overwhelmed the country’s current capacity to regulate. This paper examines the new challenges the Food and Drug Administration must confront as consumer obsession skyrockets, and manufacturers and physicians engage in questionable activity to meet the rising demand. The public’s increasingly casual attitude toward FDA approval of cosmetic uses has endangered an industry enamored, at all costs, with the pursuit of wrinkle-free, ageless beauty. This danger is compounded by the Internet’s creation of unprecedented marketing channels for manufacturers to inundate consumers with misleading information and sidestep FDA prohibitions.
1. The Information Game: Analyzing the Growth of an Evolving Industry 36 2. … Blame it on the Patient: the Shifting Role between Patient and Doctor 36 3. The Information Game and the Modern Consumer’s Access 38
1. Conflicting Accounts of Incidences of Granuloma 52 2. Accusations of Illegal Use and a Cover-Up Scam She peers in the mirror to examine her frown lines, her smile lines, her crows’ feet… all lines that she has memorized, traced with her fingers, and wished away innumerable times before. But this time, she will be brave… she will accept the role that hundreds, thousands, millions of women have assumed before her; she will visit a dermatologist, a cosmetic surgeon,
causing severe disfigurement and multiple fatalities.
While illegal fillers continue to ravage lives and communities, equally difficult questions require the FDA’s attention to the shades of gray – the potentially illegal marketing and dangerous use of legal devices. For example, with the rise of the Internet, manufacturers have discovered numerous methods to sidestep FDA regulations on advertising and promotion. These tactics render virtually obsolete the agency’s power to police the marketing of cosmetic off-label uses of devices. The FDA must acknowledge this evolution while refusing complicity with the status quo, and must adjust to accommodate the changing times that come with changing technology.
The Internet creates unparalleled channels of communication between manufacturers and consumers, and consequently, unlimited opportunities for marketing. While the FDA prohibits the marketing of a device’s off-label uses to consumers, manufacturers easily transgress ethical and legal lines via the Internet. Physicians, too, reap benefits from this medium, as they market devices to consumers with misleading language.
ArteFill, The potential for consumer harms is potentially more egregious, as Canadian physicians question the veracity and intentions of the manufacturer’s safety and health claims. For example, the device’s co-founder allegedly used the device illegally, disfigured a patient, and then attempted to exclude the results from clinical studies. This unfortunate incident illustrates the extent to which manufacturers attempting to meet the demands of an extraordinarily zealous public can (and will) mislead unsuspecting consumers in the process.
Please help I live in the UK and after a year I have large hard lumps that are protruding out of my face and look like purple bruises in colour. The largest lump has now become painful. Has anyone had any luck contacting sculptra direct? Has anyone been succesful in reversing the damage?
I had sculptra 16 months ago and now have large lumps under the skin where it was injected.no one wants to take the blame.I just hope it doesnt continue to get worse and that it disapears soon.the product should be banned now..
I had sculptra injected on August 2007 and always felt a few lumps but they were not visible to anyone else. Just a few weeks ago those nudules have been growing and seem to be taking a life of their own. The plastic surgeon who injected me was one of the very beast in my area, Virginia Beach, VA and has since retired. I went to see a plastic surgeon this week to see what could be done and he said injecting (the dime size nodules near my chhek bones & midface) with a drop of steroid to help break up the lump, however he said the risk of this would be leaving a dent. Can anyone tell me if anyone has had any luck getting these horrible side effects to go away?
Several months after I had two sculptra injections in my face, I started getting large painful bumps. I also have inflammation and nerve pain. Does this ever end?
ReplyDeleteThat is my picture on this blog site. I had sculptra injected and was never given warnings that problems could persist for years. I was told the standard, its the same material that is used in absorbable sutures. It has been in use in Europe for over a decade. There may be some blood or papules at the injection site. Does that statement indicate to you that 14 months later you would have enormous painful granulomas as shown in thise picture? Some people in this "club" have granulomas 4 years later. I had such damage that granulomatous tissue was pressing on my eye ball and rectus muscles as confirmed by a CT scan. My vision in the right eye had gone all blurry. Both sides continue to react with regular painful flare ups to what i was told was an "inert" "biocompatable" filler. When I was in crisis 3 months after injection, no Doctor would touch me. The standard response was you have to return to the BOZO board certified plastic surgeon who did this to you. But he moved to another state! Finally a good doctor took pity on me. I had surgery on the right eye, mostly to save my vision. I have been on and off steroids for over a year and a half and nobody has any answers. the surgery to remove as much of this crap as possible (not all) ended up distorting my lower lid so it is all droopy... Looks like I will need MORE corrective surgery. This has been an assault on my face. The lumps and pain dont seem to go away. What a horror this product has caused me.
ReplyDeleteI will just recap what I hope this Esteemed PHD did not say at the Nov. 08 FDA Medical Device Advisory Conference, Dermal
ReplyDeleteFillers:
"The patients have already voted for the Procedure. They're coming in with lots of Money in hand and have Voted for the Procedure."
Now to me, I'm not an esteemed PHD, but that person seems to have an agenda and not patient safety. That is my Vote.
Wrong Dr.. The Patients are not being informed. No woman in her right mind if properly informed of the risks associated with these semi permanent and permanent dermal fillers would agree. We are being sales pitched, marketed to in office and mislead by the Dr. Madoff's; The boys the Big Drug Companies just love to send their reps to meet. Just place those bogus brochures right there where she can't miss it, those woman will never know the Photos of results are not attainable with just injections. Please. Just think dr. you can make $2000 for one hour of injecting this stuff, not bad.
Who invited this guy???
The Drug Companies or the Physicians for Injectable Safety Counsel?
Having this type of input at this particular conference on Dermal Fillers, while woman are being mislead and harmed by MDs is insane and exact reason woman will keep on being harmed. No, I walked in as a patient assuming (my fault I guess) the title of MD of this board certified plastic surgeon's door at very least, I wasn't be mislead by Dr. Madoff. So yes the drug companies will continue to profit and the Dr. Madoff's will continue to harm woman and blame the patient. There are no rules when you walk into the door for a cosmetic consultation. It is your fault. It was who t their trust to because of this titleat title.e Conference, who scheduled this guy to be a part of this? The big drug companies or the Doctors for Injectable Safety?
Karen follow up,
ReplyDeleteI am up at 4:30 in the morning, oh yes just felt more Sculptra horror in my eye area and now a lump of this garbage is affixed to the bone under both of my eyes. Guess I wasn't deformed enough.
Do plastic surgeons actually take facial anatomy classes, or just practice on female patients?
Oopps, I just went too close to her eye with a needle full of diluted suture material, well not sure I got that mixture right, I better read that part next time. What is she gonna do to me anyway? I got the best lawyer in town. Let's see, can he say her blindness was due to a
pre existing condition? Yeah.
Good dispatch and this post helped me alot in my college assignement. Thank you for your information.
ReplyDeleteThis comment has been removed by a blog administrator.
ReplyDeleteI had my third sculptra injection yesterday. While I was getting injected I noticed my eyesight became blurred. The doctor had me shut my eyes and continued the injections. Afterwards I opened my eyes hoping that the burryness was gone and it was just temporary. It is not. 24+ hours later I still am unable to see clearly. I have an eye patch on, have pain in my eye and I have seen a specialist for eye problems. They believe the injection got in around my eye and is causing pressure which is causing me to basically have a lazy eye. They "hope" that it will reverse itself within a week. I am beyond upset if you can imagine. I am scared my eyesight will not recover and I am sitting here for a week not being able to do anything. I can't drive, I can't go to work, and I can barely keep my good eye open because it makes my bad eye hurt to have it move at all. I wish I had never done this. It is not worth losing my eyesight.
ReplyDeleteI am so sorry to read about the above poster who is having to deal with blurry eye problems.
ReplyDeleteIt brings me back to when this first happened to me. Scary and hiding out in the house is exactly how it was for me and still is.
Everyday you will jump out of bed hoping the problem is better or gone. I am keeping my fingers crossed that this will heal and you'll be normal.
I truly believe this will clear up. The solution they use today is not as concentrated as it was when it first hit the market.
Give it some more time... But if its getting worse you should see the eye doctor again. or a different eye specialist.
The final kicker is we had to pay for this on top of being injured...
The doctors aren't responsible and its just not right.
I am hoping the best for you.
Keep us posted.
Please email me with your address and we can try to help you out. be sure to report this event to the FDA. reporting information can be found on the www.sculptradamage.com website in the reading room under FDA information. please email me directly at sculptradamage@gmail.com
ReplyDeleteWe hope you are going to be ok. it is very important to report this to the FDA and to the company. Thank You
I very trustingly had Sculptra injections a year ago. 2 months ago my face started to itch really bad, then the lumps started and have got progressively worse ever since. The "doctor" who done this is sending me to a specialist of course claiming that I had an underlying autoimmune disease to start off with. I asked why I wasnt warned of this possibility and she said it was so rare to have a reaction that it wasnt worth mentioning. After having extreme low self esteem and depression after a long term relationship breakdown this is devastating for me, I AM VERY ANGRY. Is it worth my while to seek legal advice? I live in Australia.
ReplyDeleteThought I would have got a feedback from comment posted. Maybe you need to update website?
ReplyDeleteDear Jillian,
ReplyDeleteI also "now" of course, only AFTER Sculptra injections have several symptoms of an autoimmune disorder. I was extremely healthy before these injections, no more. All of these horrid symtoms were the results of Sculptra injections and the Drug Company getting these toxic pellets into the hands of any Dermo or Board Certied Plastic Surgeon. Whoever graduated from medical school with a speciality in either of the two who and will risk patient safety for money.
Thank you for acknowledging my comments, I hope you are OK, meaning inside yourself. I am still tossing up about getting legal advise, has anyone sucessfully done it yet? Jillian
ReplyDeleteHi Jillian,
ReplyDeleteIf you email me at sculptradamage@gmail.com I can email you directly. Yes, I am as OK as anyone can be in this awful situation, meaning my face is all messed up because some plastic surgeon got creative and decided to practice on my face. opps he needs more practice. We have a law firm that is looking into both the physician and the product liability issues. We can only hope for the word to get out so that others are not harmed. We trust that doctors will do the right thing by us and that is not the case so often. unfortunately they do not disclose the true hazards a procedure or device offer. instead they tell us it is safe and bad things dont happen when they do it... again opps so sorry i messed up your face and your entire life. Next.
Dear Jullian,
ReplyDeletePlease remember the person who is organizing this website obviouly is very sick from these injections of a very risky Dermal Filler. I have the constant attacks of nerve pain, confusion and instense attacks of disfigurement from the systemic diseases a "doctor" created / triggered in me. Of course, no warning of the risks. I never in a million years if informed allowed this dr. who made a huge profit to Inject. Being in a very similar situation, a living nightmare I can wake from, I can't even begin to do what she was done. I hope you are beginning to feel a little better. With time most of us very harmed have not recovered. Not what you want to hear, but I continue to develop more "late on" symptoms of diseases with time.
Keep us updated on your condition. Remember also you can report the surgeon or dermo who did this to you to The Office of Professional Medical Contact. Please do.
Hello to all of you going through this thing same as me. Just when I think its a bit better it all flairs up again. Just got bills today for in depth blood tests taken!!! F..k what now. Jillian Stuart.
ReplyDeleteI have had temporary fillers, juvederm for the last few years and have been fairly pleased with the results. I have heard a lot of the wonders of sculptra and was interested to learn more. I googled it a bit more today and a found links to your page.
ReplyDeleteI certainly wont consider having it done now. I will stick with my temporary fillers.
It seems to ne this is a time bomb youve hit on. It will eventually come out. I guess all you can do is keep arguing your cause. Make the most of sites like youtube, lots of people watch it!
Deb, UK.
I wanted to make sure you all saw this by Dr. Arnold Klein who is speaking out for the good of the people.
ReplyDeleteCNN Larry King's illuminating Dr. Arnold Klein interview VIDEO ...
Jul 9, 2009 ... Tonight on CNN s Larry King show, Dr. Arnold Klein revealed some interesting ... "The FDA is run by the drug companies," shared Klein. ...
www.monstersandcritics.com/.../CNN_Larry_Kings_illuminating_Dr._Arnold _Klein_interview_VIDEO - Cached - Similar
May 1, 2009 ... The FDA is also requiring manufacturers to send doctors a letter warning of the risk. ... used their positions to develop fiscal ties with pharmaceutical companies. ... These same doctors run medical societies, edit and advise trade ...
Arnold William Klein, MD. Professor of Dermatology and Medicine ...
blog.newsweek.com/blogs/labnotes/.../botox-warning.aspx - Cached - Similar
Over the years, I have watched the profession of medicine be severely abused by doctors in high level political positions who’ve used their positions to develop fiscal ties with pharmaceutical companies. The FDA, medical societies, continuing medical education organizations, and physicians (once distinguishable entities) have so enmeshed themselves with pharmaceutical companies that it is all but impossible to see where one begins and the other ends. Physicians supported by these companies promote their products, not only to other doctors but to the public as well (and in many cases, despite proven evidence of the safety of the product or products). These same doctors run medical societies, edit and advise trade publications, appear on the Internet and television, and speak before the FDA. They conduct the studies and write the papers necessary for FDA approval—papers published in leading medical journals that often contain inaccurate data. The public should be alarmed and changes in the pharmaceutical industry and the FDA need to happen immediately. Somehow and in some way, I must warn the public of the potential danger that exists at the end of the needle. The next innocent person to be exposed to this danger could be you. If you are reading this, please help me spread the word.
Arnold William Klein, MD
Professor of Dermatology and Medicine
David Geffen School of Medicine at UCLA
Arnold Klein Chair in Dermatology at UCLA
Report Abuse
An article on other fillers: Scupltra is just one but there are others causing problems such as: Radiesse (formerly known as Radiance, silicone, artefill (formerly known as artecoll) dermalogen & cymetra (both made from pooled cadavers (deceased people), both which are known to risk diseases such as prion CJD disease.
ReplyDeleteSpace did not allow me to post the entire article, so I suggest you look it up & read it yourself. I have included parts of it only:
Exploring the Evolution of the Injectable Filler Industry and the Consequent Implications for Regulatory Action
Angela Esther Kim
Class of 2006
Food and Drug Law
3L Paper
Professor Peter Barton Hutt
May 19, 2006
Abstract: Although the American pursuit of youth and beauty has long influenced female consumers, the recent introduction of injectable fillers has overwhelmed the country’s current capacity to regulate. This paper examines the new challenges the Food and Drug Administration must confront as consumer obsession skyrockets, and manufacturers and physicians engage in questionable activity to meet the rising demand. The public’s increasingly casual attitude toward FDA approval of cosmetic uses has endangered an industry enamored, at all costs, with the pursuit of wrinkle-free, ageless beauty. This danger is compounded by the Internet’s creation of unprecedented marketing channels for manufacturers to inundate consumers with misleading information and sidestep FDA prohibitions.
1. The Information Game: Analyzing the Growth of an Evolving Industry 36
2. … Blame it on the Patient: the Shifting Role between Patient and Doctor 36
3. The Information Game and the Modern Consumer’s Access 38
1. Conflicting Accounts of Incidences of Granuloma 52
2. Accusations of Illegal Use and a Cover-Up Scam
She peers in the mirror to examine her frown lines, her smile lines, her crows’ feet… all lines that she has memorized, traced with her fingers, and wished away innumerable times before. But this time, she will be brave… she will accept the role that hundreds, thousands, millions of women have assumed before her; she will visit a dermatologist, a cosmetic surgeon,
causing severe disfigurement and multiple fatalities.
While illegal fillers continue to ravage lives and communities, equally difficult questions require the FDA’s attention to the shades of gray – the potentially illegal marketing and dangerous use of legal devices. For example, with the rise of the Internet, manufacturers have discovered numerous methods to sidestep FDA regulations on advertising and promotion. These tactics render virtually obsolete the agency’s power to police the marketing of cosmetic off-label uses of devices. The FDA must acknowledge this evolution while refusing complicity with the status quo, and must adjust to accommodate the changing times that come with changing technology.
The Internet creates unparalleled channels of communication between manufacturers and consumers, and consequently, unlimited opportunities for marketing. While the FDA prohibits the marketing of a device’s off-label uses to consumers, manufacturers easily transgress ethical and legal lines via the Internet. Physicians, too, reap benefits from this medium, as they market devices to consumers with misleading language.
ArteFill, The potential for consumer harms is potentially more egregious, as Canadian physicians question the veracity and intentions of the manufacturer’s safety and health claims. For example, the device’s co-founder allegedly used the device illegally, disfigured a patient, and then attempted to exclude the results from clinical studies. This unfortunate incident illustrates the extent to which manufacturers attempting to meet the demands of an extraordinarily zealous public can (and will) mislead unsuspecting consumers in the process.
This comment has been removed by a blog administrator.
ReplyDeletetest
ReplyDeletePlease help I live in the UK and after a year I have large hard lumps that are protruding out of my face and look like purple bruises in colour. The largest lump has now become painful. Has anyone had any luck contacting sculptra direct? Has anyone been succesful in reversing the damage?
ReplyDeleteI had sculptra 16 months ago and now have large lumps under the skin where it was injected.no one wants to take the blame.I just hope it doesnt continue to get worse and that it disapears soon.the product should be banned now..
ReplyDeleteHas anyone had an MRI after sculptra. If so, please let me know what happened to the sculptra after the MRI.
ReplyDeleteI had sculptra injected on August 2007 and always felt a few lumps but they were not visible to anyone else. Just a few weeks ago those nudules have been growing and seem to be taking a life of their own. The plastic surgeon who injected me was one of the very beast in my area, Virginia Beach, VA and has since retired. I went to see a plastic surgeon this week to see what could be done and he said injecting (the dime size nodules near my chhek bones & midface) with a drop of steroid to help break up the lump, however he said the risk of this would be leaving a dent. Can anyone tell me if anyone has had any luck getting these horrible side effects to go away?
ReplyDelete