Dermal Fillers: Synthetic vs Non-Synthetic. The FDA, Ethics and Money
PART I of IV
VISAGE MedArt is an ambassador, full on supporter of many, natural, bio-degradable DERMAL FILLERS (facial volume enhancers) currently on the market. Dermal Fillers have been used around the world for over two decades with continuous annual growth of injection procedures. Filler injections have become THE most popular non-invasive cosmetic procedure in the U.S., surpassing Botox injections. More patients have incorporated fillers into their routine for beauty maintenance, and more and more articles on this subject appear in popular magazines giving them wide public exposure, including the under-age population.
I want any person interested in dermal filler injections to have adequate information about the safe and unsafe options available when considering this type of periodic enhancement. The diversity among dermal fillers on the global market is profound. We encourage patients to pause, ask, learn and understand.
Not only the public but also a high percentage of physicians are unaware of the safety profile of many injectables . Neither the FDA, medical literature nor beauty magazines provide adequate information concerning the problematic nature of certain synthetic fillers. The popular magazines, including fashion and beauty publications, can tend to stay away from any negative views regarding cosmetic procedures. After all, many of the advertisers from the beauty industry use their pages to glorify their products. There is no financial gain to making consumers fully educated.
How about the doctors? The medical cosmetic literature directed toward cosmetic physicians and surgeons is a problem in itself. The articles are largely written by doctors who are supported by Big Pharma; the majority of the “studies”are sponsored and financed by the same, Big Pharma. Not surprisingly, there is very little written about the possible adverse reactions and long term consequences of some synthetic fillers on the market making the perception of safety, unquestioned.
Interestingly, it is quite the opposite in some countries that have a much longer history using these products. In the United Kingdom numerous reports have been published in their medical literature describing, and criticising specific fillers, many of which have left patients with permanent, lifelong disfigurement.
Almost 70% of Britain’s Plastic Surgeons have reported encounters with patients suffering with problems resulting from certain dermal fillers. 50% of surgeons reported seeing patients with more serious complications from permanent or semi-permanent fillers of which more than three quarters either required corrective surgery or were untreatable due to permanent damage.
And yet, with very few occasional exceptions, the negative reports are invisible in our country; any discussion forum that involves patients and doctors, including well known consumer websites not only avoids negative comments but has become an easy market for self promotion, glorification of fake beauty and intentional propagation of marketed products. NEXT: The Importance of Injection Technique
PART II of IV
The Importance of Injection Technique
The technique of filler injections places a key role in achieving the most desirable results. It is also instrumental in avoiding many serious complications.
A real breakthrough came in 2007 in France with the first use of the flexible cannula for injections. By its specific design, with no sharp or cutting edges, the flexible cannulas allow easy movements within the tissue without cutting or penetrating blood vessels. These characteristics should minimize or eliminate significant bruising or bleeding and avoid the under-reported, sometimes devastating, complications. In extreme cases there can be permanent blindness or tissue necrosis/gangrene. VISAGE MedArt incorporated cannulas into our practice the following year, 2008 when the technique was embraced around the world and has become the gold standard for dermal filler injections. Unfortunately, it still remains a rarity in the US. Yes, it does increase the cost to medical offices in the way of cost of the supplies; and yes, it can make the procedure a little longer. But at VISAGE we feel strongly that the patient’s safety is worth the few extra dollars and possibly one less time consuming appointment.
But even using needles for injection can be safer and less traumatic; it only requires the understanding of a few principles of physics. The original needles included in each filler package are quite large with an extensive total cutting edge that is beveled, causing unnecessary trauma. Using smaller needles is, however, impossible with the designed and re-designed filler syringes. The only option is to transfer filler to a different syringe with optimal physical properties that allows for a smooth injection of even the thickest filler while using a tiny needle. It adds minimal cost and time to the procedure but minimizing unintentional complications is more than worth it.
Reactions to Fillers
While injection techniques improves patient safety an important thing to consider is “what is going on IN the tissue once the filler is injected”? Certain synthetic fillers are well known to induce immunologic/allergic reactions to the injected areas. Whenever a reaction occurs, the response may lead to formation of large lumps that may, over time, result in facial deformity.
In some very unfortunate circumstances, the popularity of dermal fillers for facial injections has lead to rather careless and irresponsible FDA’s approvals of several injectable agents that were well known to cause severe side effects .
Silicone
Silicone, the permanent filler, receiving blessing from the FDA and embraced by many doctors, had caused so many serious health and aesthetic problems that the Justice Department filed injunctions against certain physicians on behalf of the…..FDA, the same agency that piously portraits itself as a guardian of safety.
“U.S. Food and Drug Administration, assures purity, safety, and accessibility, as well as much-needed information regarding use.”
Big Pharma prompted the FDA approval of synthetic agents (Silicone being one) that should have never reached the market nor be used by doctors. A dangerous pattern has eroded the system where politics and money in the field of aesthetics became a guiding force at the expense of the consumer’s safety.
PART III of IV
Artecoll or Artefill?
The synthetic non-absorbable fillers can not be “digested” by the human immune system. It will force a chain reaction, leading to isolation of the particles and formation of inflammatory nodules that must be removed, usually by surgical intervention.
One such product that was approved was Artefill also known as Artecoll. The key components of Artefill-Artecoll are small, synthetic, polymethylmethacrylate spherical beads. Injections of this product had been known to be associated with scarring, and disfigurement that requires correction by surgery or, in less severe cases, by repeated injections of steroids and other potent medications.
Artecoll, the predecessor of Artefill, was removed from the list of fillers in Canada as well as Germany and Switzerland. Those countries advised physicians not to use this product and not to subject their patients to unnecessary and potentially harmful side effects.
Prior to the release of the Artefill in the USA, a senior member of the FDA was contacted with several articles related the negative experience with Artecoll in other countries. Although the evidence was overwhelming it was arrogantly ignored and the Artefill was released and recommended by many doctors who were either unaware of the problem or ignored the experience of others.
Then, with more reports of side effects, came the article in the Wall Street Journal revealing to the public the previously undisclosed safety issues and a long list of adverse reactions reported from abroad. Although the publication of the article brought down the manufacturer of Artecoll with subsequent bankruptcy, one would be naive to think it was the end of Artecoll/Artefill.
Suneva Medical Inc. San Diego, CA has brought this product back to the market and, predictably, numerous adverse reactions have followed.
As a physician, I know from my own experience that pharmaceutical companies cannot be relied upon to report adverse events , yet the FDA proclaims it can assess adverse reactions by relying on doctors and “Big Pharma” to report these directly to the FDA!
Changing the name of the product from Artecoll to Artefill , could not change its history or adverse reactions seen in the past. In many published articles, the “experts”, “consultants” and “luminaries” have been using these two names interchangeably adding to the confusion. How is it possible that Artefill received FDA approval as a “new” product if presented studies were that on Artecoll?
I can not resist but to repeat the quote:
“U.S. Food and Drug Administration, assures purity, safety, and accessibility, as well as much-needed information regarding use.”
Sculptra
Sculptra had received the initial FDA approval for treatment of HIV-associated facial lipoatrophy, a disturbing medication-related fat loss in the face. It has been now approved for individuals without HIV who are seeking cosmetic enhancement.
Sculptra is an injectable agent that apparently induces the formation of new collagen. However the FDA has never evaluated the filler’s effect after implantation; the biopsies of the injected area were omitted in FDA’s “strict” approval process!
Contrary to what the manufacturer suggests, it is an “immunologic foreign body reaction” that is noted on biopsies performed later in order to diagnose etiology of the side effects. It is the reaction that will, on many occasions, provide the filling effect and volume restoration but it may also result in lumps and nodule formation.
In the initial studies on Sculptra on HIV-related facial fat loss the nodules were visible and palpable in many patients. For example, in VEGA study exactly 52% of patients treated with Sculptra developed visible nodules; in the C & W study, injection of Sculptra resulted in the same complication in 31 percent of individuals ! Large nodules have been seen above the lips, in the cheeks, under the eye and in other sites of injections.
To make the process even more cynical one should look into the study considered by the FDA to be sufficient for approval of Sculptra for general use. The study was conducted by the team in which every single investigator was a paid consultant for the manufacturer of Sculptra! Of course, as before, no biopsies were included! Extremely high incidence of side effects as seen in VEGA and C & W studies was ignored and considered irrelevant.
The examples cited above indicate how inadequately cosmetic devices are evaluated by the FDA prior to their release.
As in the case of Artecoll and Artefill, the complications of Sculptra implantation were well known and published in the European medical publications prior to its approval in the USA . These side effects included infections, granuloma formation (tender nodules) and long term allergic reactions. Since these reactions are reportable, the FDA must have been well aware of their existence prior to Sculptra’s approval!
PART IV
“U.S. Food and Drug Administration, assures purity, safety, and accessibility, as well as much-needed information regarding use.” My personal suggestion to all who consider filler injections is to stay cautious, read as much as possible using unrelated sources of information, educate yourself and ask questions until you are satisfied. Unfortunately, much of Medicine has become business, including Aesthetic Medicine. While some business’ do not recognize sentiments or human relationships beyond business , the role of every physician is to act first and foremost in the best interest of their patients rather than taking on the role of a salesperson. Ethical engagement between the practitioner and the user of cosmetic procedures cannot be reduced simply to the question of informed consent. Doctors must recognise the limits of their own competence not only related to their skills but also with reference to understanding the motivation for their recommendations. Even if the definition of ethics becomes corrupted or becomes a matter for convenient interpretation, the meaning of ethics should not and cannot be changed.
