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Surgery and Cosmetics

Filler complications in skin of color

Ellen Marmur, Jason Emer

Wednesday, August 12, 2009

Minimally-invasive cosmetic procedures have become increasingly popular in the past decade, especially in patients with Fitzpatrick skin types IV-VI. More than 10 million cosmetic procedures were performed in the United States in 2008 alone, an increase of more than 162% in the total number of cosmetic procedures performed in 1997. Surgical procedures have increased by almost 80% and non-surgical procedures have increased by more than 233%.1

According to the American Society for Aesthetic and Plastic Surgery, the top five non-surgical procedures performed in 2008 were botulinum toxin injections, laser hair-removal, hyaluronic acid injections, chemical peels, and laser skin-resurfacing. For patients with Fitzpatrick skin phototypes IV-VI, interest in these effective cosmetic procedures has increased remarkably. Racial and ethnic groups, such as African-Americans, Asians, and other non-Caucasians, received approximately 20% of all cosmetic procedures in 2008.2

Fitzpatrick skin types IV-VI have increased melanin content and can predispose patients to various unwanted complications following even the slightest trauma. Fibroblasts are larger and more numerous, suggesting that there is active biosynthesis and turnover of collagen. On the one hand, as a result of a thicker and more compact dermis with increased epidermal melanin, darker skin is protected against UV radiation and its harmful effects, such as skin cancer formation and photodamage. On the other hand, melanocytes in darker skin show more labile responses to cutaneous injury, which often results in post-inflammatory hyperpigmentation and hypersensitivity reactions. In addition, keloid and hypertrophic scar formation are worrisome complications that might rarely interfere with an optimal esthetical result.3

Safety and Efficacy

Soft tissue fillers

Published data on the safety and efficacy of soft tissue fillers in ethnic skin are limited. Darker skin types have been historically underrepresented in clinical trials assessing soft tissue augmentation. However, recent trials have included a more substantial number of skin types, assessing those from IV to VI. Odunze and colleagues assessed the efficacy of the hyaluronic acid filler Restylane® (Q-Med, Sweden) in skin types I, II and III and compared them with skin types IV, V and VI.4 Sixty patients were included in the trial and there was a predominance of female subjects, with an average age of 56 years old. Mid-to-deepdermal injections with serial threading techniques were used whenever possible to minimize the number of puncture sites. All injections were followed with massage to smooth out the filler. Patients were re-evaluated within 2 to 4 weeks of treatment, and there was a noted substantial efficacy in individuals of skin types IV through VI. There were no short- or long-term cases of adverse events such as post-inflammatory hyperpigmentation.

This initial study series demonstrated that, although patients with darker skin are speculated to have more adverse events; for example, post-inflammatory hyperpigmentation, hypersensitivity, and keloid or hypertropic scaring, correct injection technique and choice of tissue depth might have an optimal effect on the quality of the treatment duration, aesthetical effect, and long-term patient satisfaction.

Filling substances

Grimes et al.5,6  assessed the efficacy and safety of a variety of filling substances for the correction of nasolabial folds and marionette lines in 65 African-American patients. The patients were predominantly females and had a mean age of 52 years old. Injected fillers included bovine collagen (25 patients), Restylane® (Q-Med, Sweden) (20 patients), human collagen (15 patients), and avian hyaluronic acid (five patients). Sixty per cent of the patients achieved excellent correction, whereas 40% received moderate correction. Four patients experienced post-inflammatory hyperpigmentation at the injection site, which resolved with topical steroids and hydroquinone 4% cream. No patients experienced keloids or hypertrophic scaring.

Similar results were seen in an open-label, randomized, multi-center clinical study to ascertain the safety and effectiveness of three low-concentration hyaluronic acid fillers (two avian-based and one bacterial-based) in skin of color by Grimes et al.7 Subjects enrolled had only Fitzpatrick skin types of IV-VI. A total of 119 subjects were randomized and treated, with approximately equal numbers treated with each of the three fillers. Of the five adverse events of interest (keloid formation, hypertrophic scarring, hyperpigmentation, hypopigmentation, symptoms of hypersensitivity), the only one observed was hyperpigmentation. This was experienced in a mild form in only three subjects (2.5%). Other adverse reactions, like bruising and pain were predominantly mild, did not require intervention and lasted 7 days or less. All adverse events occurred in less than 5% of the study population.

It was concluded that hyaluronic fillers were significantly well tolerated in non-Caucasians. There were no noted instances of keloidal scaring or hypersensitivity reactions to the hyaluronic acid filler, and pigmentation disorders were within the expected rates for all Fitzpatrick skin types.  Overall, the fillers provided a smooth, natural-looking wrinkle correction for at least 6 months and an excellent safety profile in patients with skin of color.

In a recent multi-center, double-blind, split-face, randomized trial by Baumann et al.8,9 a total of 439 subjects (420 completed the trial) with moderate or severe nasolabial folds were enrolled to receive one of three types of smooth-gel hyaluronic dermal fillers (Juvederm®; J30, J24HV, J30HV; Allergan, USA) (in one nasolabial fold) and cross-linked bovine collagen  (Zyplast®, Inamed Corporation, USA) (in the other nasolabial fold) and were evaluated for up to 24 weeks. Subjects were both Caucasian (74%) and non-Caucasian (26%) and the full range of Fitzpatrick skin types were represented (4% had Fitzpatrick skin type I, 24% II, 35% III, 20% IV, 13% V, and 3% VI).

The authors concluded that the smooth-gel dermal fillers offered longer-lasting correction of nasolabial folds versus bovine collagen and that the majority of subjects also preferred it. An overwhelming number of patients achieved optimal correction with only a single injection (i.e. no need for touch-ups). Safety and tolerability was assessed in detail for both groups. No subjects discontinued due to lack of effectiveness or adverse events. Additionally, the non-Caucasian patients did not experience a higher incidence of post-inflammatory hyperpigmentation, and no patients experienced hypertropic scars or keloids. Although, no analysis was completed to compare any one specific Fitzpatrick type with another, optimal corrections with few adverse effects were noted with the use of smooth-gel hyaluronic acid dermal fillers.

A recent multi-center, open-label, non-randomized, prospective trial evaluated the use of calcium hydroxylapatite (CaHA; Radiesse®; Bioform Medical; USA) in the nasolabial folds of dark skin individuals (Fitzpatrick skin types of IV-VI).11 CaHA was injected subdermally with a 25- to 27-gauge needle and participants received a range of 0.6 mL - 2.8mL of CaHA. Patients returned at 3 and 6 months to be assessed for keloid formation, hypertrophic scarring, and hyper- or hypopigmentation. No reports of keloid formation, hypertrophic scarring, hypo- or hyperpigmentation or other clinically significant adverse events were recorded. It was concluded that people with dark skin, if injected subdermally with CaHA, do not show significant adverse events such as keloid formation, hypertrophic scarring, hyper- or hypopigmentation. CaHA appears to be a very attractive dermal filler in this population.

Filler complications

There is a paucity of literature looking at filler complications in skin of color. Post-inflammatory hyperpigmentation is the most common adverse event noted, most specifically in darker skin individuals. This can last for many months and make the overall procedure cosmetically displeasing. In a recent study, 15% of 150 patients with skin types V-VI treated with hyaluronic acid fillers developed mild to moderate pigmentation changes that resolved within 12 weeks.10 Those with pre-existing pigmentary alterations are at a greater-risk for further darkening with repeat trauma and unprotected sun exposure. Fillers appear to be a minimally invasive procedure that could give optimal cosmetic results while limiting unwanted side-effects. However, more clinical trials need to be performed before we can define any full consensus statements that consider the use of these medications in people of skin color.

From our personal experiences, there appears to be a decreased risk of keloid or hypertropic scar formation from small caliber injection needles. As the needle caliber gets larger, there is a greater propensity for scar formation to occur, as seen in the use of fat transfer. Hypersensitivity reaction reports have been very low in all European studies. According to the literature, fat injections in skin of color have the increased risk of fat necrosis, reabsorption, infection, irregularity, and donor complications. To combat these potential complications when using injectable fillers, it is best to select surgical candidates who have realistic expectations and goals. To do so, it is important that a cosmetic physician obtains a comprehensive past surgical and medical history and take significant time to assess any patient requests such as temporary or more permanent results, degree of change or results expected from the planned procedure, and pain management precautions. Meticulous technique with a slow introduction of material at the correct depth minimizes complications.

Fortunately, most fillers are very user-friendly and forgiving.  We also have enzymes such as hyaluronidase to break apart the hyaluronic acid filler before it can lead to complications. Edema and erythema are very common side effects that occur at the injection site and typically resolve within 7 days. Ice packs can be used pre- and post-therapy to help combat these side effects. In rare cases, a short course of oral corticosteroids and/or topical corticosteroids might be helpful. If hyaluronic acids are placed too superficially, a Tyndall effect can occur, leaving a blue-colored tinge over the affected area. Some have success in treating this complication by puncturing the skin with a 20 G needle and expressing the filler with a comedone extractor.

Conclusion

In conclusion, fillers have become increasingly popular in skin of color. But we need more studies to examine the clinical efficiency and safety of these non-surgical procedures on ethnic skin.

Patient satisfaction is extremely substantial. To date, there is no increased incidence of post-inflammatory hyperpigmentation, keloids or hypertropic scars, or hypersensitivity reactions in the studies documented in the literature. More studies must be performed on patients of color in order to develop consensus guidelines on what injection techniques and filler choices are best for different patient skin types. It might be that injectable fillers are equally safe in all skin types but, side effects might develop or appear differently in darker skin. Therefore, physicians should fully understand the management of adverse events in darker skin prior to injecting a patient with skin of color and adhere to meticulous injection techniques.

Patient 1: Post 1 month Restylane® Patient 1: Baseline Restylane®
Patient 2: Post 3 months Radiesse® Patient 2: Baseline Radiesse®
Patient 3: Post 3 months Radiesse® Patient 3: Baseline Radiesse®
Patient 4: Post 3 months Radiesse® Patient 4: Baseline Radiesse®


References

  1. The American Society for Aesthetic Plastic Surgery. Cosmetic Surgery National Data Bank Statistics. http://www.surgery.org/download/2008stats.pdf. Accessed 16th April 2009.
  2. The American Society for Aesthetic Plastic Surgery. http://www.surgery.org/download/2008Top5_Surg_NonSurg.pdf.  Accessed 16th April 2009.
  3. Grimes PE, Few JW. Injectable fillers in skin of color. In: Procedures in Cosmetic Dermatology Series: Soft Tissue Augmentation. Edited by Jeffrey S. Dover. Philadelphia, PA: Saunders Elsevier, 2007:143-150.
  4. Odunze M, Cohn A, Few JW. Restylane and people of color. Plast Reconstr Surg. 2007;120:2011-2016.
  5. Grimes PE. Fillers in darker racial ethnic groups. Poster presented at the 2005 Annual Meeting of the American Academy of Dermatology; New Orleans, LA.
  6. Grimes PE. Structural and physiologic differences in the skin of darker racial ethnic groups. In: Cosmetic surgery in Darker Racial Ethnic Groups. Edited by PE Grimes. London: Lippincott, 2007:15-26.
  7. Grimes PE, Taylor SC, Grekin SD, et al. Safety and effectiveness of low concentration hyaluronic acid fillers in skin of color. Poster presented at the 2007 American Academy of Dermatology Meeting; New York, NY.
  8. Grimes PE, Thomas JA, Murphy DK, Walker PS. Efficacy and safety of novel hyaluronic acid-cased fillers and cross-linked bovine collagen in Caucasians and persons of color. Poster presented at the 2006 Annual Meeting of the American Academy of Dermatology; San Diego, CA.
  9. Baumann LS, Shamban AT, Lupo MP, et al. JUVEDERM vs. ZYPLAST Nasolabial Fold Study Group. Comparison of smooth-gel hyaluronic acid dermal fillers with cross-linked bovine collagen: a multicenter, double-masked, randomized, within-subject study. Dermatol Surg 2007;33:S128-135.
  10. Taylor S, Burgess C. Assessment of adverse experiences, keloid formation and pigmentary changes in subjects with Fitzpatrick skin types 4, 5, or 6 injected with hyaluronic acid gel dermal fillers. Paper presented at the 2007 American Society of Plastic Surgeons Conference; Baltimore, MD.
  11. Marmur E, Taylor S, Grimes P, et al. Six-month safety results of calcium hydroxylapatite (Radiesse) for treatment of nasolabial folds in Fitzpatrick skin types of IV-VI. Dermatol Surg, in press.
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