Standard guidelines for the use of dermal fillers

Introduction ^[1],[2]

Dermal fillers are substances used in soft tissue augmentation to enhance or replace volume that is lost in any part of the skin or subcutaneous fat. Fillers form an effective tool in rejuvenation, either as a stand-alone treatment or in combination with other procedures such as Laser resurfacing or botulinum toxin. ^[1] The use of dermal fillers in soft tissue augmentation is undergoing a renaissance period with many new filler materials appearing in the market. The practice of soft tissue augmentation was started by Neuber in 1893, who took fat from the arms and transplanted it into facial defects. In 1899, paraffin was used and was later given up due to foreign body granulomasor paraffinomas. In the 1940s and 1950s, silicone was used extensively until the commissioner of the US-Food and Drug Administration (US-FDA) declared the use of injectable silicone to be illegal. The field of softtissue augmentation underwent a revolutionary change in the early 1970s when researchersat Stanford University worked on the use of animal and human collagen as implant materials. The search for an ideal, permanent dermal filler is still ongoing and no single,currently available filler meets all expectations of the physician.

Rationale and Scope

With an increasing number of filler materials flooding the market place, any physician practicing soft tissue augmentation should possess a thorough knowledge of the filler material, including the mode of action of every material, its technique of injection, its limitations, advantages and disadvantages. These guidelines provide a minimal framework for reference to the practicing dermatologist. The field of fillers is a rapidly evolving one, with new fillers being introduced every year but no controlled, long-term data for long-term efficacy and longevity. These guidelines are therefore based on available data and experience of the task force members.

Dermal Fillers-Materials, Characters, Types and Classification

Dermal filler products possess a number of attributes: substances, substance source, compounds, performance, duration and mechanism of action, consistency, approved indication(s), and substantiation. Preferences of patients and providers may differ. With temporary fillers, per injection costs are less and complications are minor and rare. However, long-term maintenance costs are higher due to the necessity of repeated injections. With longer-duration fillers, the time-and-cost horizon is shortened but any complication can potentially be more significant. A balance is achieved when all factors are taken into consideration and tempered by the provider′s expertise and the patient′s expectations and acceptance of potential outcomes. While the perfect filler is yet to be available, characteristics of optimal filler are listed in [Table - 1].

Types of Fillers ^[3],[4],[5]

Fillers can be classified based on different criteria:

1) Based on longevity: Fillers are classified as temporary, semipermanent, and permanent depending on the longevity of action, as shown in [Table - 2].

2) Based on site of placement

• Dermal
• Subdermal
• Supraperiosteal

3) Based on origin of filler material

• Heterograft
• Allograft
• Autograft
• Synthetic material

[Table - 3] summarizes different fillers, site of placement, injection technique and their approval status from FDA.

Various brands are available in different parts of the world and it is therefore not possible to list every brand of filler available in the market. Annexure 1 shows different brands that are available. New fillers are introduced every year and it is therefore recommended that the physician seek full information from the manufacturer /distributor before using a filler.

Task Force Recommendations: Level D

1. As mentioned above, it is generally recognized that permanent and semipermanent fillers have potentially more adverse effects than temporary fillers. It would therefore, be more prudent on the part of the treating physician to use a temporary filler, at least initially, as a first injection. However, if a patient chooses to opt for a semipermanent or permanent filler for cost considerations or for longevity of results, these may be administered after duly explaining all aspects about their potential adverse affects, and recording the facts in the informed consent form.
2. In general, it is not advisable to inject different fillers in the same site in the same individual.
3. Controlled data for the longevity of the filler materials published by the manufacturing company may not always be available. Both this and the fact that individual results may vary should be explained to the patient.
4. Fillers from different countries are available in India and many of these may not have received approval from the drug authorities. It is therefore, not always possible to use only FDA-approved fillers in our country. In view of these facts, full information about the filler and its approval status should be sought from the distributor to learn about the filler substance. Moreover, every country has its own approval system and this should be taken into consideration.

Indications: Level C^[3]

1. Facial lines (wrinkles, folds)
2. Lip enhancement
3. Facial deformities
4. Depressed scars
5. Breast, buttock augmentation
6. Periocular melanoses, sunken eyes
7. Dermatological diseases-angular cheilitis, scleroderma, AIDS lipoatrophy
8. Earlobe plumping, earring ptosis
9. Hand, neck, dιcolletι rejuvenation

Of these, the most common indications of fillers are wrinkles, scars, lips, and lipoatrophy.

Informed consent should be taken after proper counseling of the patient. The consent form should include full details about the filler (chemical nature and source) to be administered, indication for which the filler is being used, expected longevity of results, its approval status, possible side effects and the cost.

Preoperative Preparation: Level C^[6]

1. History taking should include history of medications used, history of allergies, e.g ., the chances of bruising might increase in a patient on anticoagulant therapy.
2. Clinical examination, particularly of the area being injected.
3. Counseling as mentioned above.
4. Preoperative photograpy is preferable.
5. Informed consent should be taken as mentioned above.

Intraoperative Procedure: Level C^[6]

1. Clean the area to be injected and the surrounding skin with antiseptic.
2. Anesthesia (Patient comfort technique) may be needed in certain situations and in sensitive patients. Dental block (infraorbital) is preferred for lips and nasolabial folds.
3. Injection: Different techniques such as layering, tunneling, serial puncture and cross-hatching have been described. The choice of the technique depends on the physician. Volumes of injection at different sites are shown in [Table - 4]; however, this would vary depending on the depth of the fold / line / defect.

Postprocedural Precautions and Advice

• Avoid exposure to extreme cold or heat
• Avoid massaging treated areas for six hours
• Avoid strenuous physical activity for six hours
• Sleep with the head elevated for one night
• Pain medication can be taken if needed
• Resume skin care products such as retinoids, alphahydroxy acids the day after the procedure.

Complications: Level C ^{[7],[8],[9],[10]}

Complications are infrequentand usually minor; usually, permanent and long-term fillers have greater risk for complications. These include:

Immediate complications

1. Pain
2. Bruising
3. Erythema
4. Asymmetry, bumpiness, lumpiness
5. Anaphylaxis
6. Edema
7. Acneiform eruptions

Late complications

1. Inflammatory nodule
2. Tyndall effect
3. Allergic reactions
4. Vascular occlusion
5. Granulomas

Conclusion

In a short span of time, fillers have come to play an important role in the nonsurgical management of ageing skin. The technique is a safe, simple and effective modality, when used by a properly trained physician. Proper knowledge of the anatomy of the area of injection, aesthetic sense and proper patient selection are essential. Fillers can also be combined with other aesthetictreatments such as Botox, microdermabrasion, peels, thread-lifts, and Laser resurfacing. As in all aesthetic techniques, proper patient counseling with respect to achievable results is important.

Acknowledgment

The author is are indebted to Dr Apratim Goel for her inputs while preparing these guidelines