FDA Issues Safety Communication About Fillers

The FDA issued an alert to healthcare providers and consumers about the possibility of rare, but serious, injuries that may occur due to unintentional injection of soft tissue filler into blood vessels in the face. “Unintentional injection can block blood vessels and restrict blood supply to tissues. Sometimes this can result in embolization. This means the filler material has traveled to other parts of the body. This can cause vision impairment, blindness, stroke and damage and/or death of the skin (necrosis) and underlying facial structures,” according to the alert.

The FDA’s review of literature and adverse event reports identified injections into the glabella, in and around the nose, forehead, and around the periorbital region as sites where blood vessel blockage have been reported more often. The agency made recommendations for healthcare providers, including a warning not to inject soft tissue fillers if you do not have appropriate training or experience and making sure that you are familiar with the anatomy at and around the site of injection. Other recommendations include informing patients of all the risks of the procedure and the specific product you intend to use, understanding that the approved indications for use of soft tissue fillers vary depending on the product, and taking extra care when injecting soft tissue fillers, for example inject the product slowly and apply the least amount of pressure necessary.

Other recommendations include:

Knowing the signs and symptoms associated with injection into blood vessels, and have an updated plan detailing how you plan to treat the patient if this should this occur. Immediately stop the injection if a patient exhibits any signs or symptoms associated with injection into a blood vessel, such as changes in vision, signs of a stroke, white appearance (or blanching) of the skin, or unusual pain during or shortly after the procedure.

Telling patients that they should seek immediate medical attention after the procedure if they experience signs and symptoms associated with injection into a blood vessel.

Educating healthcare facility employees on how to quickly assist patients that report signs and symptoms of filler complications. They must understand how to instruct the patient to receive appropriate medical care.

Reporting to the FDA and the manufacturer any adverse event associated with unintentional injection of soft tissue filler into a blood vessel.

The FDA is working with manufacturers to update their labeling to include additional warnings, precautions, and other statements about the risk of unintentional injection into blood vessels.

The American Society for Dermatologic Surgery Association (ASDSA) stands in agreement, with a formal Board-approved position statement asserting that “only properly trained physicians should be injecting dermal fillers and botulinum toxins. Training should include an extensive understanding of cutaneous medicine and the aging face, knowledge of the various FDA-approved injectable products and their indications, experience in injection techniques appropriate to the products, and the pre- and post-procedure care involved in treatment.”

NIH Funding for Dermatologic Conditions Often Does Not Match Disease Burden

A new analysis of funding prioritization by the National Institutes of Health for skin disease offers a glimpse of cutaneous skin disease on a national level, with some disease states being possibly underfunded. Examining the relationship between dermatologic research funding and skin disease burden, investigators analyzed data from 2012 to 2013 by the National Institutes of Health (NIH) and how it measured up against the burden of disease, as measured by disability-adjusted life years in the Global Burden of Disease 2010 study (J Am Acad Dermatol. 2015 Jun 4). The cross-sectional analysis yielded 1,108 projects funded by the NIH, spannding 15 skin conditions.

In the Pipeline

Investigational Foam May Offer Itch Relief for Psoriasis Patients

An investigational aerosol foam may provide rapid itch relief as well as improvements in itch-related sleep loss for patients with psoriasis, according to new data presented at the recent World Congress of Dermatology. According to the Phase 3 clinical trial, 426 psoriasis patients were split into two groups, with 323 patients receiving Enstilar (calcipotriol/betamethasone dipropionate 50 micrograms/g / 0.5 mg/g, LEO Pharma) and 103 patients receiving placebo in the form of the aerosol foam vehicle alone. The investigators found that 37 percent of patients using Enstilar had achieved improvements in itch after three days and 84 percent of patients using Enstilar achieved improvement in itch after four weeks. Similarly, patients using Enstilar experienced improvements in itch-related sleep loss, with 36 percent improving after three days and 71 percent experiencing improvements by week four.

Radiesse from Merz Aesthetics Approved for Hands

Radiesse from Merz Aesthetics received FDA approval for hand augmentation to correct volume loss in the dorsum of the hands. Radiesse provides an immediate volumizing effect and can help to reduce the prominence of tendons and veins in the hands, delivering smooth, natural-looking results that can last up to one year. In a randomized, controlled US trial, blinded evaluators reported that Radiesse improved the appearance of both hands in 75 percent of treated patients at three months. Importantly, 98 percent of treated patients also reported improvement in the appearance of their hands at three months. Improved aesthetic outcomes as measured on the Global Aesthetic Improvement Scale (GAIS) after initial and repeat treatments correlating with clinical improvement were demonstrated in this study, with all primary and secondary endpoints being met. Most adverse events were injection site reactions such as swelling, redness, pain and bruising, which were usually mild to moderate, short in duration (lasting about one week), and required no treatment. No severe device-related adverse events were reported that required treatment.

FDA Clears Alevicyn SG Antipruritic Spray Gel

The FDA granted 510(k) clearance to Oculus Innovative Sciences, Inc. for Alevicyn SG Antipruritic Spray Gel with both prescription and over-the-counter indications.

The Alevicyn SGprescription product, using Microcyn(R) Technology, is indicated to manage and relieve the burning, itching and pain experienced with various types of dermatoses, including radiation dermatitis and atopic dermatitis. It may also be used to relieve the pain of first- and second-degree burns and helps to relieve dry waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process. Alevicyn SG will launch in the US in July 2015. 

Melanoma received almost half of the total skin condition budget. Melanoma, non-melanoma skin cancer, and leprosy were funded above what would be suggested by their disease burden, whereas dermatitis, acne vulgaris, pruritus, urticaria, decubitus ulcer, fungal skin diseases, alopecia areata, cellulitis, and scabies appeared underfunded, according to the findings. Bacterial skin diseases, viral skin diseases, and psoriasis were well matched with disease burden.

Despite some partial correlations between disease burden and NIH funding prioritization, the investigators concluded that the balance of funding may across the spectrum of skin disease may not accurately represent the burden of disease these conditions encompass.

ASDS Survey: 9.5 Million Treatments Performed in 2014

Members of the American Society for Dermatologic Surgery (ASDS) performed an estimated 3.08 million skin cancer treatments last year, according to the 2014 ASDS Survey on Dermatologic Procedures. That total represents a 15 percent increase since 2011, with the total growing each year.

In total, ASDS dermatologic surgeons performed nearly 9.5 million medically necessary and cosmetic procedures in 2014, according to survey results. 
Data were collected for the 2014 experience and generalized to represent all ASDS members. The survey was conducted Jan. 2 to Feb. 6, 2015, for data reported in 2014. Survey results are reported based on 826 physicians (a 21 percent response rate).

Of the 3.08 million skin cancer procedures performed by ASDS members in 2014, 207,000 were for melanoma—a nine percent increase over 2013. Non-melanoma treatments also increased slightly.

According to ASDS, 94 percent of members perform skin cancer treatments. ASDS initiatives aimed at addressing skin cancer include offering free skin cancer screenings through the Choose Skin Health program in partnership with Neutrogena. The Sun Safe Soccer and Sun Safe Surfing programs educate sports enthusiasts about and encourage adoption of sun-safe behaviors. The Stylists Against Skin Cancer program creates a partnership between dermatologists and hairstylists to promote early scalp skin cancer detection and to emphasize the importance of referring customers with suspicious lesions to dermatologists.

Additionally, ASDS released a pair of national public service announcement videos to coincide with Skin Cancer Awareness Month in May, one warning against indoor tanning and the other focusing on sun-protective behaviors for men. You can view these online at DermTube.com.

With increases in skin cancer treatments and several cosmetic categories, 2014 procedure totals were 21 percent higher than two years ago but remained steady overall compared to 2013 figures. Dermatologic surgeons in 2014 also performed 6.4 million cosmetic treatments—ranging from injectable wrinkle-relaxers and soft-tissue fillers to laser/light/energy-based procedures and body sculpting.