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.
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
cantsmileanymore
31 Jan 2013
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.
Tom at RealSelf
(Community Manager)1 Feb 2013
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.
chicago illinois
1 Feb 2013
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?
victim we know
19 Apr 2013
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
ArteSense - The latest development in Artecoll
www.pulmonmedical.com/surgicalproducts/artesense/index.html
ArteSense is based on cosmetic technology that has more than 20 years of experience in its field. The product is an injectable. Comparable technology has ...
You visited this page on 3/31/12.
Artesense injectable implant for skin augmentation
www.plasticsurgerycan.com/artesense.php
Artecoll® is a new type of injectable micro-implant used for the long lasting correction of wrinkles and other skin depressions. It consists of tiny microspheres ...
ArteSense® Services and Treatments in Vancouver and Richmond
www.bartlettfacialsurgery.ca/procedures/non_surgical/.../artesense.ht...
Artesense is useful for correcting nasolabial folds or other facial lines and contours as well as for lip augmentation. As with other fillers, the results are ...
Toronto MedSpa Services - Artesense
www.middletoncosmetic.com/artesense.html
In less than an hour Toronto cosmetic surgery expert Dr. Middleton can give you a more youthful appearance for years to come using Artesense™.
ArteSense™
www.smithlaser.com/fillers/artesense
Fillers like Juvéderm™ & ArteSense™ fill creases, lips, cheekbones, and also defects like acne scars, providing long lasting results.
artecoll / artesense injections canada
www.plasticsurgeryinfo.ca/plastic.../artecoll_artesense_canada.html
ArteSense (the next generation of Artecoll) is the only permanent injectable implant ... ArteSense is composed of microscopic PMMA (polymethyl methacrylate) ...
Artesense
www.torontoplasticsurgery.com/facial-aesthetics/artesense
Artesense. Artesense® is a long lasting injectable implant that is used to correct wrinkles, folds, and soften acne scars. It is composed of PMMA microspheres, ...
Artesense / Artecoll - Nancy Van Laeken
www.vanlaeken.com/facial.../dermal.../artesense-artecoll.aspx - Canada
Dr. Van Laeken is a plastic surgeon in Vancouver specializing in plastic surgery and cosmetic surgery. See the type of dermal fillers we use and suggest.
Artesense Treatment, Harley Street London
www.cosmetic-solutions.co.uk/artesense.html
Artesense is a long lasting injectable. The gel consists of natural atelocollagen and coated polymethylmetacrylate (PMMA) microbeads and is used for the ...
Can anyone recommend an Artesense physician in Canada ...
messageboards.makemeheal.com › ... › Lip Augmentation/Injections
Sep 21, 2009 – I'
It is all over the internet and a disaster like artecoll.
Since 2006 I have warned people about Artecoll,Artefill and Artesense. In 2007 in the Wall Street Journal (http://online.wsj.com/article_email/SB118834446251311594-lMyQ...) I did an article about the disastrous nature of agent and since then am no longer invited to speak at medical meetings. The true sadness of the control of medicine by the greed of doctors and Big Pharma is the patients end up scarred. 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 and Artesense by studying Artecoll. The only good news is that I have begun to treat adverse reactions to these products with injectable 5FU combined with Kenalog with very promising results. I will keep you posted.!
Thank you Dr. Klein. No way of removing the filler once it is in?
blancam
4 Apr 2012
Also, why cant I find much information about Artesense? Did this product come before or after Artecoll and Artefill?
Thank you so much for taking the time to guide us Dr. Klein. I would like to come visit you and see what you could do for my case. Is there a place where I could send you a picture?
Megan P
(Community Manager)4 Apr 2012
You can easily get a hold of Dr. Klein by clicking through to his profile, then you will see several options on how to contact him at his office.
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. I have found the best way to remove these lumps is an accurate injection of 5fu and Kenalog into them . Remember Hyaluronidase only works on Hyaluronic Acid which Artefill is not..Arnold W Klein...Things Get Ugly Over a Beauty Injection - WSJ.com
1 of this is an article I wrote in the Wall Street Journal about Artefill
So, are you saying that you do not recommend surgical removal? Since the lump is in my tear troughs, I am considering blethoplasty. However, my skin is tight under the eyes and I really don't have a lot of excess skin so that may not be the best option. I refrain from another injection since 0.2cc of hyurolonaise was I injected in the lump three weeks ago and I had a severe reaction that resulted in bletharitis and the lump was so inflamed that it cracked open. I can't find a surgeon in the area who is willing to operate until I am six months out because they believe it will go away over time. I really want to do the right thing, but I don't know what that is.
Bunny222
19 Aug 2011
I had artefill in the NL about 3 years ago and have had 3 instances of problems - each approximately a year apart. The first two times, there were small lumps and the Dr. used the steroid injection and antibiotics and it settled down. This time I started with one small lump on one side, and a mid-size puffy area on the other. Once again I was treated with teh steroid injection. A week later, the side that had the small lump now has a long lump extending all the way up from lip to nose with an additional puffy area next to it. I was put on antibiotics. Ten days later I am no better. The other side which had only a puffy area - is still puffy! What is the surgery like to remove this? Does anyone know?
reallysad
8 Jan 2012
Did you end up resorting to surgery for removal? I am considering this also since I just want it out. I don't really want to mess with steroid injections. I am worried about surgical removal though since Artifill embeds in the tissue.
rose28
23 Dec 2010
I got artefill on the brigde of my nose and the bottom is surgery the only way to get rid of it?
reallysad
8 Jan 2012
Did you resort to surgery? I would really like to speak with someone who had this stuff surgically removed because I am considering it. I have a lump in my tear trough area.
Los Angeles8432
20 Nov 2010
I has Artfill about 2 years ago. It is starting to lump. IT is visibile. I am African American and my fear is that it is creating internal scarring. Can anyone advise?
Houston4818
12 Dec 2010
You should let an experienced plastic surgeon have a look, and maybe not the doctor who did the injections. If you're near a major medical school see if there's someone on the teaching faculty in plastic surgery available for consult. In my opinion these doctors-especially concerning aesthetic elective procedures-are usually the most conservative.
LoriIB
24 Apr 2010
One more thing regarding ArteFill, if I massage the area will this help to break it up a little. I really need an answer as this is really depressing me.
Thanks.
LoriIB
21 Apr 2010
I had ArteFill injected in my NL folds, cheeks and chin area. I do have a problem in the left side of my chin area which the injector put too much in. It now looks lumpy and in certain lighting slightly scarred.
After reading all the posts I am now terrified what will happen in the future. I really went overboard with this stuff. I should have researched more and just stuck with the temporary fillers.
Regarding the chin area, the injector didn't even inject in the area I wanted and now it looks even worse. I am two months out and am still hoping that it will go down a little -- but I doubt it.
Five days ago I went for a Profactional laser treatment in the hopes that it would flatten out the area more around my chin. My face is still red and tight but I am now noticing that that lump is still there.
Anybody know of any experienced doctors in the Colorado area that I can consult with. I have a feeling that I am going to be very sorry in the future.
KJCO
(unregistered guest)
5 Jul 2009
I had artefill done approx. 18 months ago...I loved the results. I experienced nothing but positive results and would do it again in a heart beat. My results were smooth, natural, and long lasting...awesome product with awesome results!
chellamia
23 Feb 2010
It would really help if you would share your positive and negative results because how do we know if someone isn't working for the company? If a person doesn't want their identity revealed, can always crop the picture. There is a doctor here from New Jersy who has been using silikon in the lips for 10years with positive results and that is also controversial regarding "migration" I just wish people would show their pictures so we can get an idea what you are talking about. I got the silikon and only problem I experience is that if there is a change, I can't see it and I can't crop and upload from this stupid computer but I will as soon as I can.
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.
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?
my phone at the office Megan is (310) 736-2818
www.pulmonmedical.com/surgicalproducts/artesense/index.html
ArteSense is based on cosmetic technology that has more than 20 years of experience in its field. The product is an injectable. Comparable technology has ...
You visited this page on 3/31/12.
Artesense injectable implant for skin augmentation
www.plasticsurgerycan.com/artesense.php
Artecoll® is a new type of injectable micro-implant used for the long lasting correction of wrinkles and other skin depressions. It consists of tiny microspheres ...
ArteSense® Services and Treatments in Vancouver and Richmond
www.bartlettfacialsurgery.ca/procedures/non_surgical/.../artesense.ht...
Artesense is useful for correcting nasolabial folds or other facial lines and contours as well as for lip augmentation. As with other fillers, the results are ...
Toronto MedSpa Services - Artesense
www.middletoncosmetic.com/artesense.html
In less than an hour Toronto cosmetic surgery expert Dr. Middleton can give you a more youthful appearance for years to come using Artesense™.
ArteSense™
www.smithlaser.com/fillers/artesense
Fillers like Juvéderm™ & ArteSense™ fill creases, lips, cheekbones, and also defects like acne scars, providing long lasting results.
artecoll / artesense injections canada
www.plasticsurgeryinfo.ca/plastic.../artecoll_artesense_canada.html
ArteSense (the next generation of Artecoll) is the only permanent injectable implant ... ArteSense is composed of microscopic PMMA (polymethyl methacrylate) ...
Artesense
www.torontoplasticsurgery.com/facial-aesthetics/artesense
Artesense. Artesense® is a long lasting injectable implant that is used to correct wrinkles, folds, and soften acne scars. It is composed of PMMA microspheres, ...
Artesense / Artecoll - Nancy Van Laeken
www.vanlaeken.com/facial.../dermal.../artesense-artecoll.aspx - Canada
Dr. Van Laeken is a plastic surgeon in Vancouver specializing in plastic surgery and cosmetic surgery. See the type of dermal fillers we use and suggest.
Artesense Treatment, Harley Street London
www.cosmetic-solutions.co.uk/artesense.html
Artesense is a long lasting injectable. The gel consists of natural atelocollagen and coated polymethylmetacrylate (PMMA) microbeads and is used for the ...
Can anyone recommend an Artesense physician in Canada ...
messageboards.makemeheal.com › ... › Lip Augmentation/Injections
Sep 21, 2009 – I'
It is all over the internet and a disaster like artecoll.
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 and Artesense by studying Artecoll. The only good news is that I have begun to treat adverse reactions to these products with injectable 5FU combined with Kenalog with very promising results. I will keep you posted.!
Thank you so much for taking the time to guide us Dr. Klein. I would like to come visit you and see what you could do for my case. Is there a place where I could send you a picture?
You can easily get a hold of Dr. Klein by clicking through to his profile, then you will see several options on how to contact him at his office.
Hope that helps! :)
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. I have found the best way to remove these lumps is an accurate injection of 5fu and Kenalog into them . Remember Hyaluronidase only works on Hyaluronic Acid which Artefill is not..Arnold W Klein...Things Get Ugly Over a Beauty Injection - WSJ.com
1 of this is an article I wrote in the Wall Street Journal about Artefill