Polycaprolactone-based dermal filler complications: A retrospective study of 1111 treatments

Abstract

Background: Aging signs can be corrected through volume restoration in multiple soft tissue layers and in the supraperiosteal plane using hyaluronic acid (HA) or nonhyaluronic acid (non-HA) fillers. The non-HA bioresorbable polycaprolactone (PCL)-based filler with collagen-stimulating properties has a proven safety profile, but rare potential complications such as nodules and granuloma can occur. Furthermore, PCL-based fillers cannot be immediately removed by injection of an enzyme. These potential drawbacks have yet to be described in the literature.

Aims: The author performed 1111 treatments between 2015 and 2018. This study aims to review and analyze these treatments to ascertain the complication rates of the PCL-based filler. Suggestions for complication prevention and management are also discussed.

Methods: 780 patients treated with the PCL-based filler were reviewed by the physician between April 2015 and May 2018. During this period, 5595 syringes were used in 1111 treatments. All complication data were acquired by phone interviews, reports by patients, or observation at follow-up visits. Complications were subdivided into early-onset (occurring up to 2 weeks after treatment) and late-onset events (occurring more than 2 weeks to years after treatment).

Results: Among the 1111 treatments, there were 50 cases (4.5%) of edema that lasted longer than 2 weeks, 30 cases (2.7%) of bruising, 8 cases (0.72%) of malar edema, 5 cases (0.45%) of temporarily palpable lumps and 2 cases (0.18%) of discoloration. There were no cases of intravascular injection, nodules/granulomas, or infection.

Conclusion: The complication rate of the PCL-based filler was found to be low, and there were no cases of intravascular injection, nodules, and/or granulomas during the 3-year observation. Longer-lasting edema was associated with a higher injection volume and malar edema was related to lymphatic compression.

Keywords: PCL; collagen stimulator; complications; dermal filler; neocollagenesis; polycaprolactone; safety; volume restoration.

FIGURE 1

Bruising of large areas after treatment

FIGURE 2

Swelling, erythema, and induration limited to the injection site immediately after injection

FIGURE 3

72 h after brow lift and nasal bridge, mild swelling, and edema were seen at the injection site. More evident edema was seen in the regions neighboring the injection site

FIGURE 4

A, A 23‐year‐old female with a history of allergic rhinitis asked to beautify her profile. B, Her forehead, nose, medial maxilla, and medial cheek fat pads were treated using 5 mL Ellansé‐S uneventfully. Favorable improvement was observed 2 mo after treatment. C, Gradual‐onset and lasting edema mainly involving her cheeks and right forehead began 10 mo after injection. D, Malar edema resolved after two sessions of intralesional injection, with 1 mg/cm² triamcinolone covering the whole involved area—0.1 mL at each injection point (1 mL of 10 mg/mL triamcinolone was prepared by mixing 0.5 mL of 40 mg/mL triamcinolone with 0.5 mL of 2% lidocaine and 1 mL of normal saline). This was combined with mechanical disruption using a 22‐G cannula. Injections were carried out 1 mo apart

FIGURE 5

Microscopic image 13 mo after PCL treatment showing PCL microspheres with collagen deposition and a mild fibroblastic and histiocytic tissue response. Martin's Trichrome (MT) staining (×200 magnification). With permission from J Cosmet Laser Ther 2015;17:99‐101 Taylor & Francis

FIGURE 6

A yellowish hue was observed in a 64‐y‐old female on each side of the lid‐cheek junction 10 mo after <0.05 mL of the material was placed too superficially