Nasolabial Fold and Cheek Filler: What the Label Covers, Its Limits and Risks

What is nasolabial fold filler, and what does the label cover

Nasolabial fold filler is an absorbable filler a doctor injects to make the line from the nose to the corner of the mouth look shallower, and some brands' labels cover that use [1][3][6]. The nasolabial fold is a skin fold that starts beside each side of the nose and ends at the corner of the mouth [7].

Thailand's food and drug regulator (Thai FDA, อย.) says fillers are used to fill or soften wrinkles and deep lines on the face, and lists the cheek fold (ร่องแก้ม), cheek (โหนกแก้ม), forehead, under-eye, nose, chin and lips as examples [6]. The US FDA says absorbable fillers are approved for moderate to severe facial wrinkles and folds, such as nasolabial folds, in adults over 21 [1].

As an example of label wording, one hyaluronic acid filler (Juvéderm Ultra XC) is labeled for injection into the mid to deep dermis to correct moderate to severe facial wrinkles and folds, such as nasolabial folds [3]. Naming it does not mean it is better than other brands.

Labels differ by brand. The US FDA says each product was approved for specific areas of the face and hands [1], and Thai FDA says suitable areas, amount and technique for each filler are set out in its label and package insert [6]. This article gives no amounts or injection points, because the doctor sets them. For the full overview of fillers, see [[what-is-filler]].

How cheek filler differs from nasolabial fold filler

Cheek filler restores midface volume lost with age; one brand's label covers deep injection in adults over 21 for that volume deficit, and it does not list nasolabial folds [2]. The Juvéderm Voluma XC label published by the FDA lists the cheek, chin and temple [2].

The US FDA says augmenting the cheeks, lips, chin and back of the hand is an approved use of absorbable fillers [1]. So the goals differ: a fold treatment makes a skin line shallower, while cheek filler restores volume.

In that brand's pre-approval trial, 85.6% of treated people improved by at least one grade on a midface volume scale at month 6 [2]. The maker designed and funded the study [8], so read it as data for one brand, not an average for all fillers.

A global expert consensus warns that building the midface up to a youthful convexity may look acceptable at rest but can cause unwanted effects in motion, such as the midface pushing against the lid-cheek junction when smiling, or a visible ledge between the cheek and lower face. It advises assessing patients before, during and after injection, at rest and in animation [5].

Limits of nasolabial fold and cheek filler

Absorbable fillers are not permanent, and labels carry brand-specific limits, such as cannula safety at the cheek not being established in Fitzpatrick skin types V and VI [1][2]. The US FDA says some fillers are absorbed over time, so repeat treatment may be needed, and how long results last depends on the filler and the injection site [1].

In the cheek trial behind the Voluma XC label, 85.2% of treated people were still improved by at least one grade at month 12 and 67.1% at month 24 [2]. This figure is for one brand and was produced by its maker [8]. It is not a middle value for every filler. For how long fillers last, read [[filler-aftercare-lumps-duration]].

The US FDA approves permanent fillers only for nasolabial folds and cheek acne scars [1]. It says removing filler may be difficult or impossible, especially permanent fillers and those not made of hyaluronic acid [1].

The hyaluronic acid filler labels cited here say they should be used by trained, experienced health care professionals [2][3]. The US FDA says filler injection is a medical procedure, not a cosmetic treatment, and warns against injecting yourself or buying filler online, because it may be counterfeit or unapproved [1].

Risks of nasolabial fold and cheek filler

Common effects are swelling, bruising, redness, pain and lumps; the rare serious risk is filler entering a blood vessel, which can cause tissue death or vision problems [1][6]. Thai FDA lists itching, pain, swelling, tightness, redness and warmth, bruising, infection, lumps, and skin at the injection site turning paler or darker [6]. The US FDA says the most concerning risk is unintentional injection into a blood vessel, which can cause tissue death, vision abnormalities including blindness, and stroke [1].

In the cheek trial behind the Voluma XC label, 265 participants kept diaries. 98.1% reported at least one response at the injection site, including swelling in 85.7% and lumps in 81.1%, mostly mild to moderate [2]. The trial diary listed each symptom for every participant to rate, which is part of why the figures look high [2].

A pooled analysis of facial hyaluronic acid filler trials found swelling reported in 17.1% at the nasolabial fold versus 73.4% at other sites, and lumps in 2.9% versus 32.1% [4]. Results varied widely between studies, and products and techniques differed. It shows only that, in those trials, the fold was swollen and lumpy less often than other sites. It does not mean the site is risk-free [4].

The Voluma XC label says vision abnormalities have been reported after injection into the nose, glabella, periorbital area and/or cheek, with onset from immediate to 1 week after injection [2]. So the eye warning is not limited to the area around the eyes. Signs that need urgent care are in [[filler-aftercare-lumps-duration]].

Some lumps appear late. In the cheek trial behind the same label, two participants developed lumps or nodularity about 7 months after injection, were treated with medicines and hyaluronidase, and recovered [2]. An expert consensus says delayed-onset nodules can appear from 4 weeks to 1 year or even longer [9].

Questions and checks before you see a doctor

Check the registration number on the box, photograph it, and ask whether the filler's label covers the area to be injected [1][6]. The list below comes from advice by Thai FDA, the US FDA and expert groups. It does not recommend any place or doctor.

• Ask to see the product box and its Thai FDA registration number, and photograph it before treatment. You can check the number on the Thai FDA website or by scanning the QR code Thai FDA publishes [6].
• Ask whether it is an absorbable or a permanent filler, and whether its label covers the area to be injected [1].
• Ask about the doctor's training and experience injecting fillers in the face, which the US FDA advises you to ask [1].
• Ask whether there is a plan for a blocked blood vessel, for example hyaluronidase on hand and a route to an eye specialist, which an expert group says injectors should prepare [10].
• Ask for written aftercare instructions and a contact number [10].
• Never inject yourself and never buy filler online [1].