Artefill move on you?

  • Stephanie
  • 7 years ago

anyone had problems with artefill moving or shifting?

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artecoll is not artefill. artecoll was never approved by the FDA for use in the united states, though it was used commonly outside america. if people are having problems with artecoll, which they seem to be having, that's no indication that artefill too will be troublesome. the microspheres in artefill are much more uniform in size, and the manufacturer was required by the FDA to removed a static charge from the microspheres that was part of the problem with artecoll and granulomas arising.
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Be Careful of what is injected February 27, 2013 7:28 PM While injection technique is important what happens under the skin once an agent is injected is far more critical. What you seek to avoid at all costs is an immunologic or allergic reaction to the implanted substance. Why? Such reactions can cause large lumps that at times can be so severe they can result in facial deformity. In regards to bovine collagen most allergic reactions can be avoided by 2 negative skin tests. I developed double testing to avoid most all immunologic consequences of collagen injection. To illustrate what I mean, imagine what happens if you had poison oak implanted under your skin. It would not be comfortable nor would the reaction be beautiful. The popularity of this form of facial restoration also saw the approval of various injectable fillers and toxins by the FDA which should have never seen the light of day. Until recently, the effects of all injectable filling agents were temporary and very rarely associated with permanent problems. In the past, the permanent injectable silicone had been used but had been so problematic that the Justice Department filed injunctions against certain physicians on behalf of the FDA. After 2000 a dangerous pattern grew in the corridors of Washington, D.C., where politics and money changed the face of America and the field of aesthetics to the detriment of the faces of the consumers. Industry has accomplished the approval of synthetic agents which should have never reached the market. Once injected under skin the body cannot digest these agents and the immune system walls them off with resultant formation of nodules, which at times require surgical removal. One such product that was approved was Artefill® or Artecoll®. This product is polymethylmethacrylate or which is injectable Plexiglas beads. This product has long been associated in the worldwide dermatologic literature with scarring, and disfigurement only amenable to correction by surgery. At present, Artecoll®, the predecessor of Artefill®, is no longer available in Europe or Canada. In 2003, the American Society of Dermatologic Surgery newsletter 'Currents" promoted the use of Artefill® to fellow dermatologists. Physicians in this Newsletter encouraged and promoted the use of this agent. It was later revealed that at least one of these physicians had been given a large amount of stock (35,000 shares) by the manufacturer, which was not publicly revealed. We knew from the experience of Artecoll® in Canada that pharmaceutical companies cannot be relied upon to report adverse events to authorities, yet the FDA claims that it can evaluate adverse reactions by relying on doctors and "Big Pharma" to report these directly to the FDA. Furthermore, merely changing the name of the product (e.g. Artecoll® to Artefill®) doesn't change the history or adverse experiences of the past. In the literature, consultants have used the names interchangeably. Furthermore, if Artefill® is new and improved, how can one gain FDA approval of Artefill® by studying Artecoll® In 2003 The "Currents" newsletter of the American Society of Dermatologic Surgery established an expert panel on fillers from which I was excluded. This was odd as I was the filler editor of the Journal of Dermatologic Surgery as well as the recognized world authority on fillers. Could the reason be that I had lectured prior to this newsletter on the problems with Plexiglas fillers? It was well known to me that Artefill®/Artecoll® (Artes-Medical, San Diego, CA) caused severe adverse reactions which frequently required surgical removal of the product. It was later revealed that Artes founder Dr. Gottfried Lemperle, a plastic surgeon, improperly injected 10 people in the United States with some form of the company's wrinkle-filler before it was approved for market by the FDA. Subsequently, Gottfried Lemperle resigned as the company's chief scientific officer and a director but was retained by the company briefly as a consultant. Both Gottfried and his son were cited in a lawsuit filed by Hairdresser Elizabeth Sandor, 40, who alleged in May 2006 that Dr. Lemperle used Artefill® as an injection to fill her facial wrinkles in 2002. She alleges that Lemperle falsely convinced her that Artefill® had received FDA approval, and that he never disclosed his lack of license in California. Her claims detail suffering of pain and disfigurement she attributed to a reaction to Artefill. Sandor's face was inflamed, she had scarring near the injection sites and had a fever and aches and pains. Prior to approval by the FDA there were European reports of a significant incidence of large lumps 3-4 years post implantation. Furthermore both Germany and Switzerland had already advised physicians not to use this product. The purpose of the FDA is to protect the public interest in safety and efficacy of all medical products. Prior to the release of Artefill® in the USA, I contacted a senior member of the FDA with articles regarding the foreign experience with Artecoll but this did not prevent release of this product. Subsequently an article which quoted me in the Wall Street Journal revealing the seriousness of adverse reactions to Artefill® helped cause the parent company to go into bankruptcy. Recently Suneva Medicial Inc. San Diego,Ca has brought this product back to market. Why ? Because. These products have gained approval because these paid physicians ensure that the products are marketed to doctors reading the trade journals and through communications from their medical societies. These products fill the communication highways of the medical community despite a total lack of information and scientific data concerning their behavior once injected under the skin. Some of these agents have had a disastrous history abroad, but the FDA aesthetic device panel showed disinterest in these studies. Since when does the FDA not pay attention to controlled studies? The answer is simple, when their results are not agreement what the industry is supporting. The lead physicians appearing before the FDA supporting many of these agents were foreign and not licensed in the U.S. Furthermore, on at least one occasion the physician's significant financial interest in one of these companies was not disclosed. Often times the studies they performed were done outside this country and of questionable validity yet the FDA was most accepting of this data. I feel it is critical these studies be done in the USA. Throughout the time I was attempting to awaken the FDA to the problems with Artefill® I attempted to reach Stephen P. Rhodes, a pivotal individual who works closely with the Cosmetic Device Panel of the FDA. He had been working closely with Artes but only contacted me after my article was published in the Wall street Journal about the severe problems with Artefill®. In response to my article; a public hearing was held in November 2008 at the FDA regarding problems with injectables. The meeting was led by an oncologic surgeon and invited spokesmen were plastic surgeons with a poor understanding of the art and science of injectables. I spoke to the oncologic surgeon and he promised me I would be given sufficient time to speak. I traveled 3000 miles yet at the meeting was not allowed to speak to panel members and was given 4 minutes to review my 30 years experience with fillers. At the hearing they evaluated all fillers as a single group which prevented a thorough evaluation of each injectable. As a result only the most frequently used injectables received warnings. What I took away from that meeting was the realization that freedom of speech had all but been extinguished at the FDA. They was far more interested in protecting the manufacturers than the patients. In this the patients would better described as victims! ]In 2013 medical meetings have become nothing more than trade shows where drug companies discuss and demonstrate their latest wares. The meetings are often held in grand resorts at distant foreign locales. Additionally, much of the medical literature itself has evolved into nothing more than promotional material of questionable accuracy also underwritten by Big Pharma. Presently even continuing medical education (CME) in the USA is no longer a science but a business where the manufacturers of these products promote the use of filler products and even teach off label use (using the product outside of what the FDA has approved it for) without regard for informing doctors of adverse reactions. The manufacturers underwrite the costs of these large conventions and CME courses to the tune of a billion dollars annually. In the world of facial Aesthetics especially this behavior is rampant? So please be cautious of what you put in your face and read before you have anything injected. Arnold W. Klein, MD Professor of Medicine and Dermatology UCLA Klein Chair in Dermatology UCLA Consultant to the General and Plastic Surgery Devices Panel of the FDA "Doctor Klein is a brilliant physician and a amazing artist" -Larry Ellison
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no, not yet-in 6 months- (i was injected with 6 syringes of artefill from january to june 2014.) all the peer-reviewed, published medical research papers i've found through the NIH web database on 'artefill migration' conclude that it does not migrate. this includes research with full histological studies of biopted tissue samples.
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If it was treated with kenelog and 5fu does that mean its out of the spot it was put in?
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NEVER let you inject with 5FU. This is a chemo treatment!! All permanent fillers consist of acrylic. This is stated in the leaflet. The bumps are just hardened plastic. They can disappear just in one way which is cut out by a good surgeon.
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Do you know of a Doctor in Toronto Canada that has experience removing the Artecoll. I have gone to a few Plastic Surgeons and none of them are willing to remove it. My bumps are hard as you said and will not go away. After 13 years I don't believe they will ever go away if they have not by now. I realize the only way to get rid of them is to cut them out, but have no idea who to go to. Thank you for your reply
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Hi Cayman, you might try a Dr.Schwartz in Montreal
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The number of Injectables seem to increasing at a astronomic rate. Agents such as Bioalcamid, Aquamid, and Injectable Silicone are a few of the new names we are beginning to hear. The supposed experts are now trying to blame bacteria which supposedly grows on the surface of injectables ( Biofilms )for all the reactions we are seeing. How are you the patient going to decide what to use. First you talk to an expert like Scott Binder The Chief of Pathology at UCLA. He is truly the king of the microscope and says that these filler reactions are not due to biofilms but agrees that they are immune reactions of the body to agents that should never be used in humans. We both agree that TEMPORARY agents like the pure Hyaluronic acids are the best available products. Permanent fillers have permanent problems !Furthermore don’t take your face to Costco but go to someone you know is experienced in the use of injectables. Finally stay far away from consultants to drug companies because these are the ones responsible for the making the field of soft tissue augmentation into a filler fantasy where profit comes before safety. Biofilms have been found on solid breast implants but not on liquid injectables. I will find the best doc for you in Toronto.
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Wednesday, October 24, 2012 Gottfried Lemperle settled with Elizabeth Sandor in 2009 Gottfried Lemperle’s Settlement of Elizabeth Sandor’s lawsuit against Artes Medical The 2006 lawsuit of Elizabeth Sandor vs. Artes Medical USA, Inc., Prof. Gottfried Lemperle, et al. (Superior Court of San Diego; Case Number 37-2007-00083095-CU-MM-CTL) for alleged personal injury was settled on March 12, 2009, after Ms. Sandor's attorneys had realized that most of their client's allegations were either misrepresented or entirely false. Two of Ms. Sandor's allegations however, which ultimately prompted a settlement between her and Prof. Lemperle, were correct and based on the facts that Dr. Gottfried Lemperle’s long-standing German medical license is not valid in California and that ArteFill® permanent injectable wrinkle filler was not yet approved for human use at the time of her alleged injections in 2001 (despite the fact that Artes Medical had received an 'approvable letter' for ArteFill with certain conditions from the FDA at the time). Miss Sandor herself asked for injections of her acne scars- at no cost to her- as she was an early investor and shareholder in Artes Medical. Ms. Sandor was fully aware of the fact that at the time of her injections with ArteFill's predecessor product Artecoll®, Artes Medical was still in the process of working with the FDA on obtaining final marketing approval for next generation product ArteFill. Most importantly and contradictory to her allegations, Miss Sandor never suffered any disfigurement from her Artecoll injections, but rather had developed two small, well-circumscribed pimples at the injection site, which resolved spontaneously and are not uncommon with wrinkle fillers in general. Artes Medical's founder and former CEO, Dr. Stefan Lemperle, and San Diego Plastic Surgeon Dr. Steven Cohen had no involvement in any of the injections of Miss Sandor and Miss Sandor's attorney dismissed the case against both doctors as well as Artes Medical in early 2009. Posted by Gotfried Lemperle at 4:44 PM
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Dr. Klein, Thank you for your response. If you happen to know of a doctor in Toronto I am very interested in his/her name. Do you think artecoll can be surgically removed form the nasal labial lines?
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I am so happy to read about how you are so against permanent fillers. In 2003 unfortunately I made a big mistake by getting Artecoll injected into my lips. It has been a nightmare for me. I have horrible lumps and uneven smile because of the artecoll. I agree this product should not be on the market. I do not know what to do with the mess that I have created by being so stupid to get a permanent filler. People need to realize permanent is permanent and if you don't like what you see there is not much you can do about it. I live in Toronto Canada and have had no luck finding a Doctor to help me. I was wondering if you know of someone with experience removing this horrible product so I can smile again. I'm so self conscious and will not smile for photos because it looks so bad. Please help if you can and Thank You for trying to prevent this from happening to others who just are not thinking about what they are doing by using permanent fillers. Seems to be a lot of women out there that have this problem with no solution. Thanks again for trying to make a difference.
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NEVER let you inject with 5FU. This is a chemo treatment!! All permanent fillers consist of acrylic. You can read it in the leaflet. The bumps are just hardened plastic. They can disappear but in a way which is cut by a good surgeon.
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If there is an answer to the problem of permanent fillers I would love to hear about them. Many people do not understand that these are permanent. I honestly thought they were just longer lasting because the dr. I used presented them that way. If anyone knows of a Dr. who can help please post it. Thank you so much.
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I have been seeing Dr. Trevor Born in Toronto, he also practices in New York City. I had my second steroid injection today on my lips with no bruising. The injections seem to be shrinking my artecoll. Resulting in a better shape and not as uneven. Keeping my fingers crossed. You need to wait three to four weeks to see the full result. Dr Born is very gentle. He also uses 5fu in his practice but did not need to on me.Thank you so much Dr. Born!!! Next visit he will be removing the fat grafting I had between my nasal folds in 2004 with a micro liposuction on September 17th.My face is over filled by a very well know plastic surgeon!!! I will keep you posted good luck.
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Hi, how is your treatment going? I have the same problem and would like to know if the problem was resolved. Thanks.
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Can anyone recommend a reputable doctor in Toronto, ON, Canada, who administers 5fu and Kenalog injections (which I learned about on this site) to remove granulomas caused by Artecoll? I had injections in my lips and above my upper lip, 10 years ago and about 6 years ago my lips were swollen and lumpy. I went to a dermatologist and he injected cortisone which helped a bit but it looks like I have pebbles stuck in and around my mouth. The plastic surgeon I saw was no help at all and I'm getting married in a year and was hoping to be able to smile confidently at my wedding. I'm so embarrassed by it, I tell people it's scar tissue from a biking accident I had as a child. Please help. Thank you.
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a dermsurgeon friend asked her colleagues, and one suggested checking with Dr. Sheldon (http://www.derma-surgery.ca/meetdr.asp). She also forwarded me an article called "Soft-Tissue Filler Complications: The Important Role of Biofilms" that is worth looking up.

The authors provide this information:

 

Biofilms and Their
Relationship to Soft-Tissue Fillers:
The cause of foreign-body granuloma after
soft-tissue filler injection has been hypothesized to
be attributable to implantation in one session of
volumes that are too large, impurities in the agent,
or irregularities of the filler surface, but the impact
of biofilms has yet to be established. Reports of
delayed complications temporally related to systemic infections support the infectious cause.

All fillers, especially longer lasting products, have
the potential for biofilm complications....

Complications should be approached in an
algorithmic manner with early recognition (Fig.
2). If possible, one should make every attempt to
determine what was injected into the site. If the
wound is fluctuant, it should be needle-drained
and cultured. Cultures should be sent to the laboratory immediately for appropriate handling.

They also should be monitored for up to 21 days
for routine culture and atypical infections. The
initial antibiotic regimen should consist of at least
two-drug therapy, such as a quinolone and a third generation macrolide, to prevent further biofilm deposition. Macrolides have been shown to be
uniquely effective, which appears to be related to
improved accumulation in the subcutaneous fat
(where the filler material typically resides) and
may also block quorum sensing.

After a trial of antibiotics, intralesional highdose steroids should be considered. If hyaluronic acid was used, hyaluronidase should also be
considered.

Excision should be the last step. This
algorithm is exemplified in Figure 3. This patient
presented with nonfluctuant inflammation following hyaluronic acid to the lips. She was successfully treated sequentially with an antibiotic regimen,
hyaluronidase, intralesional steroids, and eventual
transoral excision.

 

 

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I also have had a terrible problem with an artecoll injection I had done 13 years ago. Unfortunately it is getting worse as my skin ages. I am interested to know if anyone has had any luck removing artecoll and the scar tissue from smile lines?

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Wednesday, October 24, 2012 Gottfried Lemperle settled with Elizabeth Sandor in 2009 Gottfried Lemperle’s Settlement of Elizabeth Sandor’s lawsuit against Artes Medical The 2006 lawsuit of Elizabeth Sandor vs. Artes Medical USA, Inc., Prof. Gottfried Lemperle, et al. (Superior Court of San Diego; Case Number 37-2007-00083095-CU-MM-CTL) for alleged personal injury was settled on March 12, 2009, after Ms. Sandor's attorneys had realized that most of their client's allegations were either misrepresented or entirely false. Two of Ms. Sandor's allegations however, which ultimately prompted a settlement between her and Prof. Lemperle, were correct and based on the facts that Dr. Gottfried Lemperle’s long-standing German medical license is not valid in California and that ArteFill® permanent injectable wrinkle filler was not yet approved for human use at the time of her alleged injections in 2001 (despite the fact that Artes Medical had received an 'approvable letter' for ArteFill with certain conditions from the FDA at the time). Miss Sandor herself asked for injections of her acne scars- at no cost to her- as she was an early investor and shareholder in Artes Medical. Ms. Sandor was fully aware of the fact that at the time of her injections with ArteFill's predecessor product Artecoll®, Artes Medical was still in the process of working with the FDA on obtaining final marketing approval for next generation product ArteFill. Most importantly and contradictory to her allegations, Miss Sandor never suffered any disfigurement from her Artecoll injections, but rather had developed two small, well-circumscribed pimples at the injection site, which resolved spontaneously and are not uncommon with wrinkle fillers in general. Artes Medical's founder and former CEO, Dr. Stefan Lemperle, and San Diego Plastic Surgeon Dr. Steven Cohen had no involvement in any of the injections of Miss Sandor and Miss Sandor's attorney dismissed the case against both doctors as well as Artes Medical in early 2009. Posted by Gotfried Lemperle at 4:44 PM
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I have the same problem with artecoll lumps in my lips. wondering if you went to Dr. Sheldon and was he able to help you.
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I live in Rockford,Il. and I had Artefill injected in March 2013. I have cried and prayed for someone who could reverse this horrible mistake. I had it done and right away knew it was a mistake. He even talked me into an extra injection. It hurt and I let him know that he should stop. He did not and now my eyes are red underneath with red bumps. I had no idea it would be anywhere close to my eyes. He was told to put it in the folds round the mouth and cheeks. Dr. seems to think it is amusing and suggested I needed more. I may not be able to help myself but I so want to warn people to read the fine print because I did not. I honestly did not know it was forever. Is there any avenue to get this to the public. I do not want others to suffer the way I have. My face is not mine anymore. I wish I had taken the plunge and had a regular facelift. At least I would have had a chance because I am told this is not going away. I hope someone comes up with a product that can help or that doctors will somehow find a solution.
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mom2jazzy, I am really sorry - I know how you feel. I had Artefill injected in March of 2010 in my chin area. It is still there and uneven - and to this day still bothers me. I have heard that F5U and Kenalog mixed together has worked for other people with this problem. Maybe you could do a search on this website for a doctor that has performed this. Also, I would call the number on the Artefill website and file a complaint about this doctor - they will look into it. Also, I would file a complaint on the Better Business Bureau to get your money back and to also have a complaint against him. You might also be able to call a doctor's board - not sure what that is exactly - and file a complaint against him for improper conduct. I hope you find a solution.
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this is devastating news, I am so sorry. Please know that I can really relate. the error made during my artecoll injection has changed my life, I am constantly conscious of it and have been for 13 years. I recently spoke with a very reputable dermatologist who suggested i contact a Dr. Shwartz in Montreal Canada. i will do that very soon and post his recommendations. the dermatologist told me that this plastic surgeon has surgically removed artecoll.
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my phone at the office Megan is (310) 736-2818

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Sep 21, 2009 – I'

It is all over the internet and a disaster like artecoll.
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