Rohrich et al proposed that complications should be classified as early, late, and delayed, and roughly defined as less than 14days, 14days to 1year, and more than 1year, respectively. On histology examination, numerous colonies of Streptococcus parasanguinis were identified; infection might be suspected as the cause of the reported complication. doi:10.1101/cshperspect.a015370, 56. doi:10.1007/s00266-016-0658-1, 128. Antibiotics has been recommended as part of the treatment.99,123,124 also refer to Table 2. Adverse event rates, for the PCL-based products, were similar. The most frequent locations were the cheek, lips and NLFs. The safety profile of the PCL-based collagen stimulator is good. A biodegradable levonorgestrel-releasing implant made of PCL/F68 compound as tested in rats and dogs. Polycaprolactone facial volume restoration of a 46-year-old Asian women: a case report. Up to May 2019, the patients in this group had been followed for at least 1year. 2015;34(7):11631172. Labet M, Thielemans W. Synthesis of polycaprolactone: a review. There were no cases of intravascular injection, nodules/granulomas, or infection. The collagen deposit leads to the prolongation of the sustained effect. The rheological properties with high elasticity (G value around 1000 Pa) contribute to the optimal network formation and placement in the tissue with even distribution of the microspheres, avoiding migration. Furthermore, the mean amount delivered by needle in this nonmalar edema group was 3.2mL, while a mean of 6.1mL was delivered by cannula. Polycaprolactone (PCL) fillers, a biodegradable polymer, not only naturally maintain the volume of the skin, but also stimulate collagen production by microsphere. doi:10.1080/10717540050120160, 25. Neocollagenesis was significantly increased by 50% in the new PCL and pre-existing PCL groups at 8 weeks (p value < 0.001). 2017;12:8. doi:10.1002/biot.201600734, 39. 2015;23(4):447458. 23. One covers the period of 20142016130 showing swelling and infection the most common, more serious events include vascular compromise, resulting in necrosis and blindness; the second from 2013 to 2017131 evidenced swelling, nodules and pain as the most frequent. J Dent Res. eCollection 2022. de Melo F, Nicolau P, Piovano L, Lin SL, Baptista-Fernandes T, King MI, Camporese A, Hong K, Khattar MM, Christen MO. The preparation and evaluation of poly(e-caprolactone) microparticles containing both a lipophilic and a hydrophilic drug. Gritzalas K. Preliminary results in using a new dermal filler based on poly-caprolactone. this site will not function whilst javascript is disabled. Complications in the cosmetic dermatology patient: a review and our experience (part I). Polycaprolactone-based materials in wound healing applications Collagen production was confirmed for the first time in humans on biopsies taken at 13 months after injection of the M-product at the level of the temple of patients willing to undergo temple-lifting surgery.61 In a recent study, collagen production was further evidenced in humans on temple biopsy, after treatment with the M-product using a different injection technique. which can mimic properties of the native skin extracellular matrix (ECM) 8,9,10. doi:10.1016/j.progpolymsci.2010.04.002, 8. Lemperle G, Gauthier-Hazan N. Foreign body granulomas after all injectable dermal fillers: part 2. Lemperle G, Duffy DM. J Ultrasound Med. Vijayavenkataraman S, Fuh JYH, Lu WF. MEDICAL DEVICE MATERIAL PERFORMANCE STUDY Polycaprolactone (PCL) Safety Profile Report Details Date of Submission December 2, 2021 Prepared For U.S. FDA Center for Devices and Radiological Health. Though PCL suffers from the limitation of being . Preliminary Characterization of a Polycaprolactone-SurgihoneyRO The clinical presentation involves swelling, festoons, and yellow deposits in the lower eyelids. sharing sensitive information, make sure youre on a federal These adverse events include but are not limited to infection, minimal acute inflammatory tissue reaction (redness, swelling, rash, oedema, erythema, lumps/nodules etc. government site. doi:10.1002/0471440264.pst658, 10. This can make patients hesitate before undergoing future treatments (Figure1). It has also better viscoelastic properties than other biodegradable polymers, and is thus easy to manufacture and manipulate, allowing a large range of structures (microspheres, fibers, micelles, films, nanofibers, foams, etc.). Complications of hyaluronic acid fillers and their managements. Biotechnol J. Polycaprolactone (PCL) fillers can improve skin texture and quality through dermal thickening and inducing neocollagenesis. Skin is a hierarchical and multi-cellular organ exposed to the external environment with a key protective and regulatory role. Cancer Chemother Pharmacol. Efficacy and Safety of Polycaprolactone in Treating Nasolabial Folds: A Prospective, Multicenter, and Randomized Controlled Trial. doi:10.1016/j.asj.2006.04.002. Rep Prog Phys. Long clinical experience in daily practice worldwide for 10 years has confirmed the volumizing and rejuvenating effect found in the clinical studies, with immediate and sustained effects. doi:10.1055/s-0036-1592340. 2014;34(3):108111. Furthermore, PCL-based fillers cannot be immediately removed by injection of an enzyme. and subcutaneous level of other facial areas, also prevent bruising. Eur Cell Mater. Terms & Conditions *Individual results may vary, multiple sessions may be required depending on the individual. Dordunoo SK, Jackson JK, Arsenault LA, Oktaba AMC, Hunter WL, Burt HM. Communication at the World Expert meeting (WEM) 2018; October 10; 2018; Barcelona, 78. 2011;4(12):3236. 2013;3(1):1926. Furthermore, the present study lacked a histological analysis, so no objective diagnosis was made of late but extremely rare events such as xanthelasmalike reaction. Bulk reprints for the pharmaceutical industry. . 1. doi:10.1097/PRS.0000000000001760, 95. Federal government websites often end in .gov or .mil. Biomaterials for hollow organ tissue engineering. doi:10.1097/PRS.0000000000003309, 107. All complication data were acquired by phone interviews, reports by patients, or observation at followup visits. The amount injected was determined by the surface area to be treated (0.2mL/cm2). 21 The safety of the PCL filler observed in the clinical studies is confirmed by the post-market surveillance (PMS) data based on the long clinical experience worldwide. CMC has been classified as GRAS (Generally Recognized As Safe) substance by the Food and Drug Administration (FDA), CMC and PCL successfully used for decades in humans in FDA-approved safe-to-use resorbable devices. Cole MA, Quan T, Voorhees JJ, Fisher GJ. 2016;9:3. doi:10.1186/s13069-016-0040-6. Huang L, Wang L, He J, et al. doi:10.1684/ejd.2017.3089. Comparative study of rheological properties and preclinical data of porous polycaprolactone microsphere dermal fillers. Collagen decrease is accompanied by an increase in metalloproteinase levels. In this comparative study, we ascertained the efficacy of a novel composite scaffold using aloe vera and polycaprolactone (A-PCL) as a carrier for Wharton's jelly mesenchymal stem cells . 2016;138(2):215e227e. J Clin Aesthet Dermatol. The Skin Deep ingredient hazard score, from 1 to 10, reflects known and suspected hazards linked to the ingredients. Treatment options. A new technique for nodules/granuloma treatment was developed in recent years as an option before surgery: the intralesional laser treatment (ILT) to help remove the product; the area is treated by local introduction of a micro-optic laser fiber several times at different places in the target area.119121 Several hundred cases involving different types of fillers, especially permanent dermal fillers were treated by ILT.119,120 This technique applied to the PCL filler showed benefit in the very few treated cases given the extremely low AE incidence.121 The physicochemical properties of the PCL polymer, with a low melting point, should make it particularly sensitive to this technique. Summary A 46-year-old Asian women was treated with a next-generation bioresorbable biostimulatory polycaprolactone (PCL)-based dermal filler to restore facial volume loss. No language restrictions were applied. 2016;9(11):15. The skin is always exposed to various types of damages (Yao et al. Sun J, Vijayavenkataraman S, Liu H. An overview of scaffold design and fabrication technology for engineered knee meniscus. doi:10.1002/adhm.201500168, 37. CMC is a well-known non-toxic cellulose derivative extensively used. Plast Surg Nurs. Dawood A, Marti Marti B, Sauret-Jackson V, Darwood A. 1 Uitto J. It exerts a dual effect, an immediate volumizing effect by the CMC gel and a sustained effect thanks to collagen production and unique scaffold formation with the microspheres. Polycaprolactonebased dermal filler complications: A retrospective In the present retrospective study, no hand treatments were performed, so the complications discussed below are associated with placement in the subcutaneous or supraperiosteal level of the facial areas. The excellent mechanical properties and low immunogenicity of PCL makes it an ideal biomaterial candidate for 3D printing of bone implants. Finally, the present review illustrates the interest in the well-known polymer, polycaprolactone, as a material in tissue engineering, besides its key role, in a new expanding domain in esthetics, by the use of the PCL-based rejuvenating filler, which opens up new perspectives. Depleted collagen, elastin and hyaluronic acid lead to lines, wrinkle sand . Recommendations for PCL filler complication treatment are provided (Figure 4). Find answers to yours questions, if you still need more information contact us. Intralesional Laser therapy (ILT) among others is an interesting option that is being further worked out. Inclusion in an NLM database does not imply endorsement of, or agreement with, Injections were carried out 1month apart, until the complete resolution was reached. The opinions expressed in all articles published here are those of the specific author(s), and do not necessarily reflect the views of Dove Medical Press Ltd or any of its employees. It is difficult to have access to PMS data of the different fillers, as they are generally not published. 2013;291(1):157165. The complication rate of the PCLbased filler was found to be low, and complications were mild in nature. J Cosmet Dermatol. The two share a common approach based on biomaterials, especially polymers. New Engl J Med. Vigorous massage, with injection of a saline solution with or without lidocaine, or subcision is used in early nodules following injection. doi:10.1056/NEJMc1206319, 42. J Eur Acad Dermatol Venereol. Satisfaction evaluated by the physicians and the subjects was high. Ferneini EM, Beauvais D, Aronin SL. It follows a kinetic law whereby length continuously and linearly decreases with time (t) via chain scission: Mn = Mn,o x ekt where t = time, Mn = molecular weight, and k = the average rate constant for chain scission. A review of biofilms and their implications on clinical practice. Chem Soc Rev. Reinke JM. 119. PCL filler safety has been particularly studied showing a good safety profile. Product presentations, Ellans-S, -M, -L are available differing in their duration of action. Blunt cannulas, which are commonly used in the treatment of the forehead, Polycaprolactone - an overview | ScienceDirect Topics Subcell Biochem. They mainly comprised edema/swelling (0.02%) or lumps/nodules (0.023%) (Figure 3). Reproduced with permission from the communication Experts round table: preventing and treating complications: case studies. The author declares no conflicts of interest. Ma G, Song C, Sun H, Yang J, Leng X. Mondal D, Griffith M, Venkatraman SS. Povolotskiy R, Oleck NC, Hatzis CM, Paskhover B. Dove Medical Press is part of Taylor & Francis Group, the Academic Publishing Division of Informa PLC Further, only one clinician carried out the injections, although this may have improved the consistency and reproducibility of the technique and may be a good control variable. J Oral Maxillofac Surg. 35. 2015;7(285):285ra64. dorsal hands, All injections can potentially cause bruising, but the complication is observed more frequently after injection into the subdermal planes using fanning and threading techniques. These usually resolve spontaneously within several days after the injection. Biomaterials. Model is not an actual patient. 2015;14(1):2732. Epub 2021 Jul 23. It is also interesting to continue elucidating the mechanism underlying the improvement in skin quality reported by many physicians as well as in clinical studies. Lee JM, Kim YJ. doi:10.3390/ma10010029, 50. 2017;9(7):Pii.a023234. At 24 months patient satisfaction was high (81.5% for PCL-M and 72.4% PCL-S).5,75 Another study, a randomized, prospective, blinded, split-face single center study was aimed at comparing PCL-S to a hyaluronic acid filler in 40 subjects followed up to 12 months. 2018;11:603611. In skin collagen type-I (85%) and type-III (10%) are predominant. The mean total facial injection volume in these eight patients was 22mL, with a mean of 11.7mL in the medial part of the midface. Anyway, infection has to be ruled out, or else antibiotherapy should be initiated. The physician should closely follow the effect of the complication treatment. The mouse full-thickness skin injury closure experiments were performed to assess the wound-healing properties of the as-fabricated electrospun fibrous scaffolds. 2017 Nov 8;10:431-440. doi: 10.2147/CCID.S145195. doi:10.1177/1090820X13493638, 90. At 24 months PCL-M was more effective than PCL-S, showing sustained improvement for the entire 2 years study period. Or L, Eviatar JA, Massry GG, Bernardini FP, Hartstein ME. 130. doi:10.1177/1553350616681889, 40. (. Ortiz AE, Ahluwalia J, Song SS, Avram MM. Schelke LW, Decates TS, van der Lugt CIM, Pelzer L, de Mey G, Velthuis PJ. , 3D printing of scaffolds for tissue regeneration applications. New collagen fibers were demonstrated by specific stainings and immunohistochemistry at 1-year post-treatment. J Dermatol Dermatol Surg. 3 Ellans contains Polycaprolactone (PCL) microspheres an effective and safe component to use over long periods, closing the gap between surgical and non-invasive treatments. Several features of , 2015;17:113141. 111. 2023 Jun;39(3):300-306. doi: 10.1055/a-1954-3986. J Biomater Sci Polym Ed. 2018;141(6):13611369. 2017;75:160166. A pore way to heal and regenerate: 21st century thinking on biocompatibility. 13 The degradation of poly (DL-lactide), poly (epsilon-caprolactone), and their copolymers in vivo. Figueiredo VM. Biomaterials. Finally, in terms of safety in the context of clinical practice, recent recommendations and reviews on the prevention and management of adverse events related to soft tissue fillers were also selected. All rights reserved. Porous functionally graded scaffolds of poly ( - ScienceDirect Specifically, 1mL of 10mg/mL triamcinolone was prepared by mixing 0.5mL of 40mg/mL triamcinolone with 0.5mL of 2% lidocaine and 1mL of normal saline solution. Research is ongoing to optimize adverse-event treatment, taking advantage of the physicochemical properties related to PCL. 61. J Cosmet Laser Ther. Am J Cosmet Surg. Plastic surgery statistics report; 2018. In vivo stimulation of de novo collagen production caused by cross-linked hyaluronic acid dermal filler injections in photodamaged human skin. IntroductionCalcium Hydroxylapatite (CaHA) is a common dermal filler used in aesthetic medicine for volumizing and contouring. Age and skin structure and function, a quantitative approach (II): protein, glycosaminoglycan, water, and lipid content and structure. doi:10.1016/j.jaad.2017.08.026, 110. Ultrasound to improve the safety of hyaluronic acid filler treatments. Sustainable drug release from polycaprolactone coated chitin doi:10.1001/jamaoto.2013.5644, 41. Aesthetic Plast Surg. 2015;219(11):521529. Signorini M, Liew S, Sundaram H, et al. doi:10.1002/(ISSN)1097-4636, 69. Identification and complications of cosmetic fillers: sonography first. The precise mechanism of xanthelasmalike reaction is unclear; it may involve the binding and internalization of lowdensity lipoprotein by macrophages because it shares common microscopic features with that process. 1985;19(4):437444. Top, Copyright 2023 Dove Press Ltd Zopf DA, Flanagan CL, Wheeler M, Scott J, Hollister SJ, Green GE. Treatment of soft tissue filler complications: expert consensus recommendations. In respect of PCL properties and past, present and future applications in the biomedical field, given the numerous publications, the search focused on reviews and recent publications illustrating some of these biomedical applications. 2009;38(12):34843504. Foreign body granulomas after all injectable dermal fillers: part 1. Malar edema can result from lymphatic compression Finally, skin replicas were used to calculate total wrinkle area (mm 2).