beverly Hills, CA
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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
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!
The filler Sculptra® was at one time considered an important agent in managing facial fat loss in HIV+ patients. Prior to FDA approval, it was used in a clandestine manner. In clinical trials evaluating this agent for correction of fat loss in HIV+ patients although the study patients were for the most part satisfied, up to 50% of the injected individuals developed some degree of lumpiness in the treated areas. Furthermore, these lumps are often far from invisible. Nevertheless, Sculptra® received rapid track compassionate release approval from the FDA for use in patients with HIV. The panelists on the General and Plastic Surgery Device panel were strongly unanimous in limiting approval only for patients with HIV. At the FDA hearing, not one histologic slide showing the fate of Sculptra upon implantation was shown. Again, how can an agent gain approval without scientific data supporting its application?
According to the European literature the consequences of Sculptra® in the normal host has been very problematic (foreign body granulomas, infections, etc.)
Here is a photograph of a patient who came to me who had an adverse reaction to Sculptra®. Frequently the only way to get rid of these lumpy ridges is to excise (cut out) them from the face.
Nevertheless, the lay press, medical conferences and internet began to promote this substance for soft tissue augmentation in HIV negative patients. The prospective studies for the use of this agent in individuals with normal immune functioning were completed and again we have another disastrous injectable.
In 2000, at the World Congress of Dermatology in Paris, Pierre Andre reported cystic, nodular, and granulomatous lesions when this agent was used in individuals with normal immune functioning (non-HIV+ patients). Additionally, long-term allergic reactions have since been described, which are very difficult to manage. In another report concerning its aesthetic use in 100 patients with normal immune functioning, 20% of the treated individuals experienced significant adverse reactions. Obviously, this product is not immunologically inert as the manufacturer stated. Foreign body granulomas are being seen with this agent in HIV-positive as well as immunocompetent patients.
While the manufacturer as well as investigators claim this product produces neocollagenesis or new collagen this is not what is seen under the microscope. On biopsy one sees a severe
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.
rnold W. Klein, MD
Professor of Medicine and Dermatology
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"