New Additions to the Cosmetic Dermal Filler Market May Present Dangerous Public Health Risks

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The ever growing desire to stay young and achieve rejuvenation without surgery may have doctors and industry turning a blind eye to patient safety. With the recent addition of products like SculturaTM, RadiesseTM and the sudden spike in the demand and use of the non-FDA approved filler AquamidTM in the U.S., what are the current dangers of being an aesthetics patient? Dr. Rian A. Maercks, a Miami Beach aesthetic plastic surgeon alerts us to the current dangers of being an aesthetic patient.

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I would never dream of injecting any of these other products into a patient's face and still call myself a doctor

In the complex healthcare sector today one thing is certain, things are changing fast. Remember the old days when an otolaryngologist was an airway surgeon? It used to be the case that gynecologists practiced gynecology, dermatologists actually treated skin conditions, internists once practiced internal medicine. Well say goodbye to yesterday and welcome the brave new world where doctors are reinvented as cosmetologists, except they wield needles and knifes. This creates ample opportunities for the irresponsible use of products and the recent spike in use, demand and internet posting of unapproved fillers such as Aquamid from Europe to Fix-a-Flat from your local auto parts store(,,,, .

The declining financial reward of medicine and a general governmental and public neglect for recognizing the value of a good doctor has created a hunger that has turned into greed. Fed by the unyielding power of big business and their offers of ‘business partnerships’ to these practitioners, many doctors have turned green. The changes we are seeing do not only remove doctors form their much needed roles in the specialities which they were trained, they create a significant public health risk. By turning away from patients and focusing on profits, doctors no longer stand as a safety net between corporate greed and clinical decision making for their patients. Many turn over a new leaf and become “aesthetic practitioners” by attending a weekend training course on injectables and fillers or just by following the directions of their sales representative which holds a Bachelors degree in business as their most significant credential. This translates into a ‘Wild West’ of cosmetic medicine. Newly created associations and ‘boards’ spring up every day to trick patients into believing that their doctor is qualified to treat their aesthetic concerns. The end result- No one is driving so big business takes the wheel.

Miami Beach aesthetic plastic surgeon Rian A. Maercks M.D. reports that "disasterous interventions are being sold to patients every day."    “It’s the physicians job to evaluate any treatments appropriateness for any given patient whether the treatment is 100 years old or came to market yesterday. This is what is missing from the equation and as a result plastic surgeons are seeing horrific consequences.” Dr. Maercks has a significant population of patients that have entered his care after being treated by medical doctors outside the field of plastic and reconstructive surgery. “The medical community is putting everything but the kitchen sink in peoples faces while turning a blind eye and hiding behind FDA approval.” Dr. Maercks explains that although FDA approval is arduous, it doesn’t really follow clinical findings far enough to protect patients. The corporation’s goal is to take something inexpensive that the FDA has already approved for some indication and short circuit the process by applying for a new indication for an approved substance. “Why do you think the two most popular long term injectables are basically bone cement and a relatively reactive suture material? These are both horrible ideas as every surgeon knows about the destructive nature of these materials in soft tissue. " "Doctors are literally injecting construction materials into faces every day, but it was an outrage when the news discovered an individual injecting fix-a-flat into customers” Dr. Maercks explains.

The products Dr. Maercks refers to are RadiesseTM which is made of hydroxylapatite, the same material as bone cement and SculpturaTM which is made of poly-L-lactic acid the same material as VicrylTM sutures. “Ask a plastic surgeon about tissue coverage issues over hyroxylapatite and they will likely have a look of anguish on their face as they remember granulomas, infection, exposure, tissue destruction of cases that they helped their orthapedic colleagues with in residency but for some reason many will return to clinic and inject this into a paying cosmetic patient’s face!” “Ask any plastic surgeon how frequently they deal with suture abscesses after a large incision closure like surgery after massive weight loss due to poly-L-lactic acid sutures and everyone will tell you that it happens routinely. How much sense does it make to inject this material into the human face?” Dr. Maercks explains emphatically. A quick review of the many patient websites such as will reveal granulomas, infections, exposures painful bumps as results these materials being injected.

The question remains “why are people doing this?” Dr. Maercks believes a tremendous portion of doctors have lost sight of appropriate scope of practice. He believes that doctors in general have lost sight of their role at the intersection of the patient, the government, the FDA, financial pressures and industry. “We are supposed to advocate for and protect the patient, we all took an important oath that doesn’t seem to be paid heed any longer…some doctors have always ignored their role for profit, if you want to see how this sort of thing repeats itself look at the history of silicone or polyacrylamide injections on a timeline. Some doctors still perform these injections” Dr. Maercks explains.

Polyacrylamide is a waste water treatment and agricultural soil conditioner has been injected in Europe for quite some time and is currently being sold as AquamidTM. Aquamid is not yet approved in the U.S. but the demand is clearly here as it is being used and marketed by practitioners in the U.S.( Polyacrylamide has also caused devastating complications in patients worldwide that have contacted Dr. Maercks for help, but the marketing push moves swiftly forward( Severe potentially life threatening emergencies have been attributed to this product even years after injection( "I find the AquamidTM website so surreal and creepy I get the shivers, it makes you feel dirty like it sucks out your soul in some well made satyrical movie" Dr. Maercks commented.

Silicone was developed as an electrical insulator and quickly found an aesthetics role in post war Japan when freely injected as a breast enhancement for prostitutes. The devastating effects of free liquid silicone led to a complete ban in Japan in the 1950s. The US FDA followed behind in 1965 following more complications allowing only doctors with permission to conduct human experiments to continue( Robert Yoho M.D. Dr. Maercks still sees patients that have currently received silicone treatments and need corrections.

Dr. Maercks has never carried nor has he injected these materials because of these obvious findings. The doctor feels that performing these prcocedures is completely unethical and is embarrassed that this happens. Maercks reports that not all doctors are doing this with compromised ethics. “It’s a problem caused by disintegration of scope of practice. Most practitioners are shielded from seeing the complications, the company is not going to show them and when a patient has a bad complication they usually don’t go back to the original injector, they find a plastic surgeon with aesthetic and reconstructive experience like my practice” Dr. Maercks explains. "The original practitioners believe they are performing valuable interventions because they are behind the veil of ignorance not evil". It doesn’t help that the companies conveniently describe the foreign body reaction and scar deposition as naturally stimulating “your body’s own collagen [making] your skin [look] even better over time” and claim to be “the first wrinkle treatment that can help replace lost collagen. Dr. Maercks explains “that’s a very convenient way to describe a hard subdermal scar ball that can stretch your skin, erode your fat and age your face.”

"It is a scary time for medicine when we are warned to avoid the Snake Oil Salesman and that includes some doctors, when the patient becomes more like a targeted consumer and the doctor becomes more like a peddler of snake oil," (Dr. John Moore III, However, there still exists some truth and some doctors dedicated to preserving it for their patients. Dr. Maercks urges the patient consumer to avoid any facial fillers that are not relatively unadulterated hyaluronic acid, a naturally occurring substance in the human body, or their own autologous fat. Dr. Maercks reinforces “I would never dream of injecting any of these other products into a patient's face and still call myself a doctor.”

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