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Alternative-sourced Aesthetic Formulations: Injecting Risk

Aesthetic injectable procedures—known to be quick, minimally invasive, and generally effective—are in a rare but increasing number of instances also dangerous, prompting aesthetic physicians to lead a charge to stop risky procedures across the US. In efforts to ensure patient safety and preserve the well-earned reputation of these popular procedures, top physicians, societies, and even the FDA are weighing in with warnings about questionable practices, such as compounding sclerosants or purchasing injectable agents from unlicensed providers.

One of the recent warnings came during last fall's ASDS Annual Meeting, where the American Society for Dermatologic Surgery Association (ASDSA) issued a statement urging, “federal and state regulatory authorities to re-examine their oversight and enforcement of compounding pharmacies.” The statement, made in the wake of the highly publicized Massachusetts compounding pharmacy contamination that has resulted in the deaths of 45 people and illness of hundreds of others, says that “Providing uncontaminated drugs at consistent, appropriate dosage levels must be of paramount concern.” Said ASDSA President Timothy C. Flynn, MD in the statement, “We are seeing too many cases of patients becoming ill or dying due to lack of appropriate oversight of compounded pharmacies.”

In Dr. Flynn's home state of North Carolina, a woman died in 2005 as a result of application of a compounded topical anesthetic prior to a planned aesthetic procedure. That death and a spate of other medical emergencies associated with compounded topical anesthetics led to large-scale abandonment of such products in favor of supervised application of pharmaceutical-grade anesthetic formulations. Concerns about inconsistency in the quality of compounded sclerosants is paving the way for a similar move toward use of the available pharmaceutical-grade sclerosants only.

In 2004, ASDS President-elect Mitchel P. Goldman, MD of La Jolla, CA published an article in Dermatologic Surgery (30: 1454-6) where he reported that three out of three pharmacy-compounded samples of the sclerosant sodium tetradecyl sulfate 3% did not contain the claimed concentrations of the active ingredient. In addition, Weiss, et al. in 2011 (Dermatol Surg; 37(6): 812- 5) found that five out of six pharmacy-compounded samples of polidocanol 1% did not contain the claimed concentration, and all six samples contained impurities. In both studies, the pharmaceutical grade formulations— Fibrovein (STD Pharmaceuticals, Ltd.) and Asclera (Merz Aesthetics), respectively—contained the claimed concentrations of active and no impurities.

“The risk of injecting a sclerosant that is not the correct concentration is too little of a reaction and recurrence of the vessel or, more importantly, too vigorous of a reaction resulting in excessive inflammation and/or ulceration or thrombi formation,” Dr. Goldman says. “In addition, as we have reported, there are a wide variety of impurities in the compounded sclerosing solutions.”

When FDA-approved formulations were not available, compounding was a clinician's only option. But that's no longer the case. Asclera, for example, was approved by the FDA in 2010, and is available nationwide. Using compounded formulations as an alternative is, according to Dr. Goldman, “unnecessarily risky” and illegal. Physicians who use an improperly compounded agent endanger patients, and they put themselves at risk for litigation.

Omaha's Joel Schlessinger, MD, FAAD, founder of the Cosmetic Surgery Forum, echoes this reality, noting that compounding and so-called “grey market” purchasing “is likely going to result in potential issues for those who dabble in this area. Injectables such as botulinum toxins and polidocanol are subject to FDA oversight, and for the protection of our patients, it is best to avoid importation.”

The issue of grey market injectables gained prominence in December when the FDA said it had sent warning letters to more than 350 medical practices that the agency says may have received unapproved medications, including unapproved versions of Botox, from a foreign supplier. “This is a continual issue, it seems. Sadly, many practitioners, including dermatologists who should know better, still persist in thinking that it is acceptable to purchase ‘grey-market' pharmaceuticals,” Dr. Schlessinger observes. “The reality is that this practice is fraught with danger, both to the patient and the physician's reputation.”

In its December statement about unapproved formulations, the FDA indicated that it “cannot confirm that the manufacture and handling of these products follow US regulations or that these medications are safe and effective for their intended uses. Medications not approved by FDA may also lack the necessary and required labels that ensure their appropriate and safe use.”

Renato Saltz, MD, FACS, Past Vice-President of the International Society of Aesthetic Plastic Surgery (ISAPS) and Past President of the American Society for Aesthetic Plastic Surgery (ASAPS), also commends the FDA's action on this issue, as well as the agency's initiative to supervise the use of injectables in the US. “Patient safety should be the primary goal of every physician/surgeon practicing aesthetic medicine today,” says Dr. Saltz, who is also a member of the multispecialty Physicians Coalition for Injectable Safety (PCIS). With a stated mission to “provide the public with unbiased and necessary information on injectable cosmetic treatments, appropriate injectors and where to safely access cosmetic medical procedures,” the PCIS is one of several organizations striving to eradicate the use of un-official formulations of aesthetic injectables and increase oversight of how aesthetic medicine is practiced. “The incredible growth of aesthetic medicine in the past few years combined to the multitude of non-properly trained physicians engaged in the practice of non-surgical procedures is very concerning,” observes Dr. Saltz. Many states are only now addressing the wave of poorly or non-supervised medical spas that open at every corner of every city in America, according to Dr. Saltz. “The public must be protected from the incredible lack of training, supervision, and ethics offered in many centers.” Dr. Saltz observes. That is why the PCIS was created, according to Dr. Saltz.

The ASAPS is also very active in similar efforts, urging patients to, “Know what you are being injected with...Make sure your clinician is using only FDA-approved products purchased within the United States. If he or she refuses to give you this information, seek another clinician.” Similarly, in its document for physicians “Guidelines for Ethical Patient Safety Practices in Today's Rapidly Changing, Complex Environment,” the ASDS states that, “The importation and use of non-FDA approved or compounded substances have resulted in adverse events and even death. To alert the public to the dangers of cosmetic procedures performed by a non-physician without direct physician supervision, the Society engages in an ongoing communications campaign to educate consumers.”

The ASAPS also cautions patients not to select an injector based on cost. Cost-cutting seems to be the driving force in the use of non-FDA approved or non-pharmacologic injectables by physicians and other providers. But the long-term consequences could be far more costly—both in financial and in more figurative terms—if patients receive inappropriate injectables.

There are safe, ethical ways to reduce costs, Dr. Schlessinger says. “The safest way to save money is to purchase in a co-op with other physicians...Additionally, there are ways to purchase in bulk and decrease overall costs.”

Furthermore, cost considerations may be part of therapeutic selection when choosing from among FDAapproved agents. “Competition among manufacturers has led to significant decreases in costs and opportunities that didn't exist even months ago, so this is a great time to seek a better deal from your suppliers,” says Dr. Schlessinger. This, along with incorporating other smart cost-saving strategies, such as buying in bulk, may be key to reducing costs in an ethical manner.

While the problem of unlicensed vendors as well as non-properly trained practioners is not likely to cease, efforts by the FDA and most importantly aesthetic clinicians will be key to spreading awareness about these issues. “First and foremost, physicians cannot compromise their ethics and patient safety,” says Dr. Saltz.

Obagi Fate Unclear as New Deal Details Emerge

Following a bidding war with rival Merz Pharma Group, Valeant Pharmaceuticals appears set to acquire Obagi Medical Products. Valeant's original offer came in March, when the company announced that it would acquire Obagi at $19.75 per share, in a deal worth approximately $344 million. Then, in early April, Merz Pharma Group formally proposed to acquire Obagi, with an unexpected $383.5 million bid. Merz sent a letter to Obagi Medical Products Inc.'s board offering to buy all of the company's stock for $22 per share. According to the Associated Press, Merz said that it had been in private talks with Obagi before that deal was announced and wasn't aware that it was considering signing a deal with another company so quickly. Following this, Obagi announced that Valeant had ammended its original offer and increased its offer to $24 per share. The expiration of the tender date is April 23 at midnight. As of early April, Merz has not indicated whether it plans to make a higher offer.

Scars/Stretch Marks Significantly Impact Women's Confidence

A new survey reveals that men and women have complex and often differing feelings about how their skin imperfections impact their appearance and confidence. In the Mederma Wear Your Skin Proudly™ survey, 34 percent of women reported that the appearance of scar(s) and/ or stretch marks would make them feel self-conscious while being intimate with their partner. In addition, 44 percent of women felt that improving the appearance of their skin imperfections such as scars and stretch marks would help improve their overall self-confidence. The survey also found that women are more self-conscious about the appearance of their scars and stretch marks, with 33 percent reporting that their scars and stretch marks negatively affect their self-confidence, while only 19 percent of men feel this way. For more information on the survey and about Mederma's family of products, visit www.mederma.com.

District Court Blocks Marketing, Sales of RevitaLash

A district court judge prohibited Athena Cosmetics, Inc. from marketing or selling its RevitaLash Advanced Eyelash Conditioner in the US. The ruling came as part of a civil lawsuit brought by Allergan Inc., maker of Latisse, in which the company claimed unfair competition in the marketplace based on the way Athena Cosmetics labeled and marketed RevitaLash Advanced Eyelash Conditioner. Athena Cosmetics will fully comply with the ruling; however, the company intends to appeal the ruling to the US Court of Appeals for the Federal Circuit. International marketing and sales are not affected by the ruling.

Merz to Absorb Costs of New Excise Tax on Medical Devices

Merz Aesthetics does not intend to raise prices on medical devices, despite the new excise tax of about 2.3 percent on the sale of certain medical devices now going into effect, per the Patient Protection and Affordable Care Act. In a statement to clients and potential clients, Merz Aesthetics Vice President Jim Hartman noted that the company has opted to absorb the costs rather than raise prices on value partners and potential partners. “We continue to commit to being an excellent partner to your practice and helping your business thrive, through ongoing investment in programs that support you clinically, drive consumer demand and add value to your practice,” said Mr. Hartman. For more, visit www.merzusa.com.

Botched Breast Implants Top UK Cosmetic Surgery Claims

Cosmetic Surgery Solicitors, a Manchester-based law firm specializing in cosmetic surgery negligence, has revealed that breast augmentation procedures gone wrong account for half of all cosmetic surgery claims handled. The group has seen a significant increase in patient inquiries seeking claims for bad implants in the last 12 months. However, the British Association of Aesthetic Plastic Surgeons says of the 43,172 surgical procedures performed in 2012, nearly 10,000 were breast augmentations. Breast implants remain the most common cosmetic surgery procedure performed in the UK.

CeraVe Launches Barrier- Repairing Sunscreens

Seven new sunscreens are available through CeraVe. The new line includes: CeraVe Sunscreen SPF 50 for Face is a purely physical sunscreen that utilizes zinc oxide in a high-tech, micronized form: INVISIBLE ZINC™ technology. The elegant, lightweight, oil-free lotion spreads easily and dries on your face with a clear finish. CeraVe SPF 50 Sunscreen for Body also features INVISIBLE ZINC™ technology, but is available in a larger size; CeraVe Sunscreen for Body is also available in SPF 30. CeraVe Wet Skin Spray SPF 50 can be applied to wet or dry skin. Its lightweight, oilfree formula, containing ceramides and hyaluronic acid, applies easily and dries on skin with a clear finish. Once sprayed on the face or body and spread evenly by hand, it forms a barrier that is water resistant (up to 80 minutes), and retains maximum sun protection. CeraVe SPF 50 Sunscreen Stick is a physical-only facial sunscreen stick with INVISIBLE ZINC™ technology. Like all CeraVe products, the sunscreen formulations contain ceramides for skin barrier repair.

Social Media a Major Influence on Elective Surgery

Social media is leading consumers to have a more selfcritical eye, according to a new survey by the American Academy of Facial Plastic and Reconstructive Surgery (AAFPRS); respondents reported a 31 percent increase in requests for surgery as a result of social media photo sharing. Of all procedures performed in 2012, 73 percent were cosmetic versus reconstructive in nature, up from 62 percent in 2011. You can read more about the survey, including comments from Robert Kellman, MD, President of the AAFPRS, online at ModernAesthetics.com.

Research Breifs

Poor Communication Main Reason for Formal Surgery Complaints

Researchers investigating reasons for plastic surgery patients making complaints and claims of negligence have found that poor communication is the main reason for formal complaints. The researchers analyzed complaints data over a 10-year period from 185 patients and found that the most common reasons for complaints were poor communication and treatment delays. A total of 20 claims of negligence were made, 14 of which were from patients undergoing breast surgery. In addition, three successful cases mentioned adverse scarring, suggesting that this risk was either not discussed or the informed consent process was inadequately documented. The researchers concluded that poor communication is the main reason for patients making formal complaints, however inadequate documentation of informed consent discussions may also contribute to successful negligence claims.

— J Plast Reconstr Aesthet Surg. 2013 Jan 8.

Zonal Analysis of Facial Asymmetry Can Benefit Surgeons In Patient Consults

Researchers conducting a frontal photographic analysis of 50 patients seeking various types of facial cosmetic procedures found that 45 patients demonstrated measurable asymmetry of the midface. In addition, the malar eminence was more superiorly positioned and defined on the narrower side of the face in all cases. In contrast, the contralateral wider side of the face appeared flatter, with a more hypoplastic, inferiorly positioned malar eminence. Also, the wider side of the face more often demonstrated a wider mandibular dimension and a superiorly displaced ala. The upper third of the face was the most variable and showed little correlation to the lower two-thirds of the face. Investigators concluded that this facial analysis exercise assists the surgeon in pre-operative counseling, managing expectations, choosing appropriate-sized implants, and offering a more detailed assessment during the counseling of patients before face-lift surgery.

—Arch Facial Plast Surg. 2012 Mar 1: 1-3

Isolated Neck-Lifting Procedure Shown Effective

Isolated stork lift (ISL) procedures provide excellent lifting of the anterior, lateral, and posterior neck without the resulting postoperative sequelae of vertical/ diagonal lines, especially for patients who do not want to undergo a lower face-lift procedure at the same time, according to a new report. Researchers performed the ISL procedure on 273 patients over a 2-year period. Of these, 240 patients rated their satisfaction with the results as very high, 21 rated it as high, and 12 rated it as somewhat satisfied. Two patients needed a minimal amount of submental liposuction after the procedure, while no patients had vertical/diagonal skin folds after this procedure. In addition, five patients reported being slightly bothered by the appearance of the midline posterior scar for the first six months. The researchers noted that three of these cases involved hypertrophic scarring and were treated with intralesional triamcinolone suspension. The remaining 268 patients reported that the final posterior scar was virtually undetectable. Also of note, 10 patients needed scar revision for secondary widening of the scar at various locations of the lateral, posterior, and or nape of the neck. There were no other significant complications. Most patients were satisfied with their cosmetic result two years after their operation.

—Aesthetic Plast Surg. 2013 Jan 10

Anatomic Predictors of Unsatisfactory Mid-Face Surgical Rejuvenations

Successful mid-face rejuvenation requires accurate diagnosis and avoidance of anatomic pitfalls, a new study finds. Investigators performed a retrospective review of 150 patients who underwent surgical mid-face rejuvenation by a single surgeon. They recorded demographics, history, procedures, outcomes, and complications. Results of physical examination and photography were used to classify patients by volume loss, mid-face ptosis, skin elasticity, and skeletal anatomy. Outcome was determined by patient satisfaction at the 12-month follow-up. Patient dissatisfaction was encountered in 14 percent of cases. Autologous fat grafting alone demonstrated the greatest propensity for dissatisfaction, with four out of 12 cases resulting in dissatisfaction. However, dissatisfaction rates were significantly higher with malar hypoplasia (41 percent vs. 7 percent) or loss of elasticity (16 percent vs. 3 percent). The researchers concluded that unsatisfactory results are most common when mid-facial aging is accompanied by skeletal insufficiency or loss of elasticity. They recommended in cases of these defects that clinicians consider the placement of malar implants and rhytidectomy approaches targeting the mid-face.

— JAMA Facial Plast Surg. 2013 Jan 24:1-9

Artefill Associated with High Patient Satisfaction for Malar Augmentation

Artefill (Suneva Medical) demonstrated improvement in malar atrophy and may result in a high level of patient satisfaction, according to in a recent study. Researchers investigated the safety and efficacy of Artefill for malar augmentation in 24 patients with age-related lipoatrophy. Artefill was injected in the supraperiosteal layer of the malar region at a maximum volume of 6mL (3mL/side). Touch-up injections were performed at weeks 4 and 6, up to a maximum total volume of 8.8mL. Standardized assessments of results were made at two, six, and 12 months. Based on both the patient- and physician-rated GAIS, 95.8 percent of study participants were reported as being “improved” or “very much improved.” In addition, the change in malar lipoatrophy grade was significantly improved from baseline to one year by 0.96 ± 0.98. Moreover, 87.5 percent of patients reported high levels of satisfaction. Researchers noted the near absence of adverse events.

Novel Combination Approach to Structural Facial Volume Replacement

The combination of treatments with fillers; toxins; light, sound-, and radiofrequency-based technologies; and surgical procedures may help to forestall the facial aging process and provide more natural results than are possible with any of these techniques alone. The authors of a new overview article reviewed key components to the reported strategy for improving facial cosmesis, which include: augmentation of volume loss; protection with sunscreens and antioxidants; promotion of epidermal cell turnover with techniques such as superficial chemical peels; microlaser peels and microdermabrasion; collagen stimulation and remodeling via light, ultrasound, or radiofrequency-based methods; and muscle control with botulinum toxin. For the treatment of wrinkles and for the augmentation of pan-facial dermal lipoatrophy, several types of fillers and volumizers including hyaluronic acid, autologous fat, and calcium hydroxylapatite or injectable poly-Llactic acid (PLLA) may be incorporated. In addition, a novel bimodal, trivector technique to restore structural facial volume loss that combines supraperiosteal depot injections of volume-depleted fat pads and dermal/subcutaneous injections for panfacial lipoatrophy with PLLA has also shown to forestall the facial aging process and provide natural results.

—Aesthetic Plast Surg. 2013 Apr;37(2): 266-76