Sutures were among the first devices made of synthetic absorbable polymers (including PCL), with the advantage of reproducible slow degradation in biological tissue. doi:10.1080/00914037.2015.1103241, 21. conducted by the manufacturer, more than 490000 syringes were used from the launch of the product in 2009 to December 2016, with a low complication rate of 0.049% (one event per 2055 syringes). Synthetic biodegradable polymers as orthopedic devices. Mrs Marie-Odile Christen reports personal fees from Sinclair Pharma, outside the submitted work. Forehead and dorsal nasal injections are the area leading the most to vascular complications. and subcutaneous level of other facial areas, also prevent bruising. Woodruff MA, Hutmacher DW. DEXLEVO, a company from South Korea, had invented the world's first liquid polymer filler, also known as GOURI. PCL is biodegradable and bioresorbable. doi:10.1097/PSN.0000000000000053, 126. J Cosmet Laser Ther. , In aging, affecting fat, bone, muscles, and ligaments, loss of collagen, its disorganization and fragmentation play a central role in the associated skin changes52 with also changes in other components of the ECM.53,54 The fragmentation of the collagen fibers impairs its interaction with the fibroblasts, inducing modification of the cell morphology, thus reducing mechanical forces. 10 Available from: https://www.plasticsurgery.org/documents/News/Statistics/2018/plastic-surgery-statistics-report-2018.pdf. 61. doi:10.1097/PRS.0b013e31818236d7, 115. The deposits placed on the supraperiosteal plane did not exceed 0.2mL/injection point; in the subcutaneous plane, the amount for each linear thread placed by cannula did not exceed 0.1mL/cm. Wounds caused by disease and trauma can lead to a loss of function, which can be debilitating and even cause death. 12 Adv Mater Res. Malar edema can result from lymphatic compression 11. 2013;39(6):915922. Compared to other domains, tissue engineering and esthetics have dramatically expanded in recent years, leading to both major biomedical advances and futuristic perspectives. Polycaprolactone, a well-known polymer, has several specific and interesting properties: it is biocompatible, slowly biodegradable and bioresorbable. 2011;1(1):2226. doi:10.1111/jocd.2013.12.issue-1, 81. de Melo F, Nicolau P, Piovano L, et al. Vigorous massage, with injection of a saline solution with or without lidocaine, or subcision is used in early nodules following injection. 23 Topical report. The PCL-filler is presented in 1mL sterile syringe. Mrs Marie-Odile Christen reports personal fees from Sinclair Pharma, outside the submitted work. Clin Cosmet Investig Dermatol. A total of 5595 syringes were used in the 1111 treatments. Szojkaa A, Lalha K, Andrewsa SHJ, Jomhaa NM, Osswalda M. Biomimetic 3D printed scaffolds for meniscus tissue engineering. Figure 4 summarizes the proposed treatment guidelines for the management of those side effects. 0344. doi:10.3390/ma10010029, 50. doi:10.1111/j.1524-4725.2009.01348.x, 120. , In one study, a foreign body reaction was observed in one patient 3years after treatment. Of these, 17 did not develop malar edema and had a mean injection amount in the medial midface of 9.3mL. This phase shows a controlled, and predictable first-order linear pattern, dependent on the water permeability and length of the polymer. - Injection related reactions, include itching, discoloration or tenderness may occur at the site of the injection. 86. Comparative Evaluation of Physical Characteristics and Preclinical Data of a Novel Monodisperse Polycaprolactone Microspheres Filler. 2017;75:160166. Mogosanu GD, Grumezescu AM. It is indicated for subdermal implantation in the face for long-lasting correction of facial wrinkles, aging signs or any facial age-related conditions, and for hand rejuvenation. Unable to load your collection due to an error, Unable to load your delegates due to an error. 2019;20:2126. doi:10.3390/ijms2009212652. C, Gradualonset and lasting edema mainly involving her cheeks and right forehead began 10mo after injection. J Biomater Sci Polym Ed. Up to May 2019, the patients in this group had been followed for at least 1year. In the decade since the PCLbased dermal filler was launched, it has shown advantages over the polyllactic acid (PLLA)based injectable because its results are immediately visible, as well as over HA and CaHAbased fillers because it confers stable and durable results. In 2009, the PCL-filler received CE marking, as a Class III medical device. doi:10.1038/sj.bdj.2015.914, 38. In the collagen stimulators, the polymer-based products have the longest action duration. In contrast, histopathology of a nodule reveals an overabundance of product; this is distinct from a granuloma, which shows an overabundance of host tissue reaction to a small amount of product, indicating an immune origin that depends on the host's immune status or incidents that cause changes in immune status. To prevent nodules (in addition to avoiding injection of the product in the lips and the periorbital area), the recommended techniques to be used are linear threading, fanning, and crosshatching in the subcutaneous plane and injection of only small bolus (no more than 0.2mL) supraperiosteally. The short second phase starts when the polymer is more highly crystalline and reaches a chain length of a low molecular weight of around 30005000 Da, allowing the small fragments to diffuse through the polymer matrix. The Skin Deep ingredient hazard score, from 1 to 10, reflects known and suspected hazards linked to the ingredients. This is part of biomaterial biocompatibility.6567 The type and degree of the reaction between material and host depend among others on the properties of the implant: composition, size, shape, surface, roughness, porosity. 1994;11:381393. 2017;4(3):63. 2016;65(5):255265. WSRS and GAIS results were significantly improved at 6, 9 and 12 months.76 These studies provide a proof of concept, demonstrating longer duration for the M- than the S-product5,75 and longer action duration of the S-product than a hyaluronic acid filler.76 A recent European, multicentric clinical study was conducted, including 90 patients with moderate to severe NLFs followed for 18 months after single injection and no touch-up. J Microencapsul. The CMC gel is resorbed in 23 months. As for any product, safety is based on the safety of the components and the finished product. The PCL-filler is made of PCL microspheres of 2550 m size which protects them from phagocytosis.67 Not only the size but also the shape has been shown to greatly influence the tissue reaction.68 The shape, round or irregular determines the degree of reaction. Full resolution can be expected within several days to 1week, without any intervention required. 2014;77(4):046603. doi:10.1088/0034-4885/77/4/046603, 74. doi:10.1007/s00266-017-0798-y, 89. A panel of physicians recommended prophylaxis with anti-inflammatory enzymes (Wobenzym Vital 2 capsules per 12 hrs; bromelain 300 mg/kg, divided in 3 doses); arnica/gelsemium 45 pills per 24 hrs for 34 days; cold compresses (for about 5 mins) and anti-inflammatory drugs (NSAIDs and streptokinase/streptodornase) for treatment of moderate cases.105. HHS Vulnerability Disclosure, Help Aesthetic Plast Surg. The reaction regressed after 1month of treatment using oral doxycycline. Swelling, erythema, and induration limited to the injection site immediately after injection, 72h after brow lift and nasal bridge, mild swelling, and edema were seen at the injection site. PCL is biocompatible and biodegradable. 4. doi:10.1055/s-0036-1592340. 2015;94(9 Suppl 2):S153S157. Urdiales-Glvez F, Delgado NE, Figueiredo V, et al. Collagen, the most predominant protein in human body and skin and a major component of the extracellular matrix (ECM) has not only an essential structural role of support but is a functional protein interacting at different cellular levels. Porous functionally graded scaffolds of poly ( - ScienceDirect - Rare but serious adverse events associated with the intravascular injection of soft tissue fillers in the face have been reported and include temporary or permanent vision impairment, blindness, cerebral ischemia or cerebral hemorrhage, leading to stroke, skin necrosis, damage to underlying facial structures, nausea and vomiting, lack of ocular movement, significant skin changes, ptosis, exotropia and neurological complications. Together, these clinical studies demonstrated the long-term efficacy of the PCL-filler in different area and conditions and improved skin quality. Between April 1, 2015 and May 31, 2018, a total of 1111 PCLbased filler (EllansS) treatments were performed using a total of 5595 syringes (1mL/syringe). Dr Franco Vercesi is the International Key Opinion Leader for Sinclair Pharma. These usually resolve spontaneously within several days after the injection. J Eur Acad Dermatol Venereol. 2015;8:56715701. Skin Res Technol. Fitzgerald R, Bertucci V, Sykes JM, Duplechain JK. Edema/swelling was usually of mild or moderate intensity and spontaneously resolved in a few days. doi:10.1126/scitranslmed.aad3106. The PCL-based collagen stimulator is composed of PCL microspheres suspended in a carboxymethyl-cellulose gel carrier providing immediate and sustained volumizing effects when injected; the morphology, the biocompatibility of the PCL microspheres embedded with the collagen fibers produced all contribute to the creation of a unique 3D scaffold for a sustained effect. 2006;27(9):17351740. 13 The intracellular degradation of poly(epsilon-caprolactone). Goldberg D, Guana A, Volk A, Daro-Kaftan E. Single-arm study for the characterization of human tissue response to injectable poly-L-lactic acid. doi:10.1097/PRS.0000000000002350, 121. The injection technique used in the present study involved volume placement in multiple anatomical layers. This is the first and currently the sole collagen stimulator that is made of PCL. Ultrasound-assisted management of filler-related complications: Report of a successful treatment of delayed-onset nodules related to polycaprolactone-based filler. Efficacy study of the new polycaprolactone 2012;49:3543. Polycaprolactone Electrospun Nanofiber Membrane with Skin Graft Plast Reconstr Surg. Schelke LW, Decates TS, van der Lugt CIM, Pelzer L, de Mey G, Velthuis PJ. 2013;3(1):1926. To this end, we prepared a bi-layer construct where the top layer acts as bandage, and the bottom layer acts as a dermal equivalent graft. 2017;31(3):405413. Furthermore, the present study lacked a histological analysis, so no objective diagnosis was made of late but extremely rare events such as xanthelasmalike reaction. 16 doi:10.1001/archderm.144.5.666, 71. 22. Clin Cosmet Investig Dermatol. Polycaprolactonebased dermal filler complications: A retrospective 9 Interestingly, ultrasonographic characteristics have been defined, allowing clinicians to identify and localize the PCL filler during injection and in case of complications. Its specific physicochemical and mechanical properties, viscoelasticity and ease of shaping led to the production of PCL-based products with various shapes and durations dependent on its biodegradation kinetics. 2008;7(2 Suppl):S12S16. To conclude, complications caused by dermal fillers are rare and mostly minor and injection-related but physicians have to be aware of the risk and be able to manage and treat adverse events, particularly the severe ones. Using hyaluronic acid (HA) or nonHA fillers, aging signs can be corrected through volume restoration in multiple soft tissue layers and at the supraperiosteal level. Neocollagenesis after injection of a polycaprolactone based dermal filler in a rabbit. doi:10.2147/CCID.S145195, 82. ELLANS | Dermal Fillers for Natural Collagen Stimulation Intralesional laser treatment for dermal fillers complications. Carreras N, Acua V, Mart M, Lis MJ. With permission from J Cosmet Laser Ther 2015;17:99101 Taylor & Francis. A 10-point plan for avoiding hyaluronic acid dermal filler-related complications during facial aesthetic procedures and algorithms for management. Recently published experts' recommendations on injection modalities and techniques should help further optimize treatment outcome and safety. Labet M, Thielemans W. Synthesis of polycaprolactone: a review. Ortiz AE, Ahluwalia J, Song SS, Avram MM. Among the PCL drug release systems, the biodegradable contraceptive capsule Capronor made of PCL containing levonorgestrel has particularly been investigated regarding its design and long-term experimental (up to 2 years) and clinical development, providing important information on the global safety of PCL and confirming the PCL slow degradation process and the long-term safety of those drug release systems17 Many other drugs have been encapsulated in PCL microspheres, in particular: anticancer,24,25 antipsychotic,26 non-steroidal anti-inflammatory,27,28 anti-hypertensive drugs29 and, others. Dr Franco Vercesi is the International Key Opinion Leader for Sinclair Pharma. Clin Cosmet Investig Dermatol. This indicates that an increased filler amount delivered in the deep fat plane by cannula could confer a higher risk of compromised lymphatic drainage (Figure4). 2011;4(12):3236. ELLANS can be applied with an anesthetic cream or local anesthetic injection to ensure totally pain-free administration. Reproduced with permission from the communication, MeSH Figure 4 Proposed treatment guidelines for PCL filler complications. Research is ongoing to optimize adverse-event treatment, taking advantage of the physicochemical properties related to PCL. Extracellular matrix regulation of fibroblast function: redefining our perspective on skin aging. 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. It is a very promising therapeutic approach which has now become a reality.3439. Injectable products to fill wrinkles; July 2012. As with any transcutaneous injection, infection is always possible, even if the rate with the PCL-based collagen stimulator is extremely low. The other one, a case of induration of mild intensity on both nasolabial folds, disappeared spontaneously. Clin Rev Allergy Immunol. doi:10.1097/PRS.0b013e3181858f4f, 116. 2019;39(12):NP484NP494. caused by the filler and can occur both superficially and deeply in the malar septum: a band of connective tissue that divides the superficial suborbicularis oculi fat into superficial and deep compartments. Pharm Res. PCL can save lives. For the superficial and deep fat placements, a retrograde fanning technique was performed using 25G, 40mm cannulas. Late and delayed complications may be secondary to granuloma and biofilm formation, respectively. The original characteristics as well as the efficacy, duration of action and safety of the PCL filler are described below with a special focus on safety. Furthermore, PCL-based fillers cannot be immediately removed by injection of an enzyme. The author performed 1111 treatments between 2015 and 2018. without placement of the product in any contraindicated areas, such as the periorbital area, lips, and labella. Gels. See this image and copyright information in PMC. Aesthet Surg J. What is GOURI and what is PCL? , Its specific physicochemical and mechanical properties, viscoelasticity and ease of shaping led to the production of PCL-based products with various shapes and durations dependent on its biodegradation kinetics. 2017;10(1):pii:E29. Prevention of adverse events also depends on post-procedural care. , Heimowska A, Morawska M, Bocho-Janiszewska A. Biodegradation of poly(-caprolactone) in natural water environments. 2015;17:113141. Classification of the complications by the author. These potential drawbacks have yet to be described in the literature. We can employ temporary products which remain in the skin for between 3-8 months; we can use collagens or hyaluronic acids (which are simply fillers - the injected volume is the only effective change); or we can apply durable products, which have lasting effect from 18 months to 2 years,* such as ELLANS, a Polycaprolactone-based filler (with a secondary action that stimulates the natural production of collagen for more enduring results). The supraperiosteal placement was carried out by vertical puncture using 27G, 1in needles. Tracheal suspension by using 3-dimensional printed personalized scaffold in a patient with tracheomalacia. Complications in the cosmetic dermatology patient: a review and our experience (part I). 2 J Control Release. indicating an inflammatory/infectious cause. The PCL microspheres contribute to longterm volume by stimulating new collagen production. Nodule formation is always associated with the injection technique of the practitioner; in most cases too much material has been injected at a single point, or product has been placed in a hypermobile depth level. Early complications generally consisted of acute inflammation, infection, or ischemiarelated problems. Tissular induction and the role of collagens: from development to senescence. The present article provided additional safety information in a large population of 780 patients and 1111 treatments that were followed up for 3years. doi:10.1093/jb/mvw082, 73. Safety was followed up for 30months in a recent European multicenter clinical trial involving 90 subjects. doi:10.1016/j.jaad.2017.08.026, 110. Eur J Aesth Med Dermatol. J Oral Maxillofac Surg. government site. Although the PCL-filler is not known to be associated with granuloma (incidence rate of 0.002%), it is important to provide information on the treatment recommended by a group of experts, that can be used by physicians to handle this complication, given the seriousness for their patients. Possible causes. doi:10.1097/PRS.0000000000004428, 122. Huang L, Wang L, He J, et al. Collagen decrease is accompanied by an increase in metalloproteinase levels. J Drugs Dermatol. doi:10.1002/(ISSN)1097-4636, 69. doi:10.1111/dsu.12164 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. In the present article, the complications were classified as early (occurring up to 14days after treatment) and late (occurring weeks to years after treatment) (Table3). 3D printing and 3D bioprinting in pediatrics. Epub 2019 Jul 26. Kim JH, Ahn DK, Jeong HS, Suh IS. On histology examination, numerous colonies of Streptococcus parasanguinis were identified; infection might be suspected as the cause of the reported complication. Graivier MH, Bass LM, Lorenc ZP, Fitzgerald R, Goldberg DJ, Lemperle G. Differentiating nonpermanent injectable fillers: prevention and treatment of filler complications. Agence Nationale de Scurit du Mdicament et des Produits de sant (ANSM). Register your specific details and specific drugs of interest and we will match the information you provide to articles from our extensive database and email PDF copies to you promptly. doi:10.2147/CCID.S180904, 105. Use of the PCLbased dermal filler has not been limited to the subcutaneous and supraperiosteal levels of the face; increase in skin thickness was shown in a studyusing a particular not recommended dermal injection technique. Waller JM, Maibach HI. 2015;219(11):521529. ), pain (which may be temporary or persistent in nature), transient haematoma or bruising. The power is in the results, see them for yourself - here. 119. Dove Medical Press is part of Taylor & Francis Group, the Academic Publishing Division of Informa PLC doi:10.1001/archderm.143.2.155, 70. resulting in necrosis and visual symptoms. 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. Complications of hyaluronic acid fillers and their managements. J Cosmet Dermatol. The treatments of granuloma after injection with another polymer-based collagen stimulator (Polylactic acid PLLA), often reported before the proposed dilution protocol, are detailed in the American and European recommendations,113,118 and follow similar modalities. JAMA Otolaryngol. doi:10.1097/DSS.0000000000001202, 123. 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. Or L, Eviatar JA, Massry GG, Bernardini FP, Hartstein ME. Fundamental investigations of its mechanism of action should provide new insight into its effects, in relation to collagen stimulation and 3D-scaffold formation. 2022 Feb;46(1):429-436. doi: 10.1007/s00266-021-02470-6. Several clinical studies assessed the efficacy and duration of action of the PCL-based collagen stimulator; the S and M products were commonly used in those studies. The .gov means its official. Front Cell Dev Biol. The excellent mechanical properties and low immunogenicity of PCL makes it an ideal biomaterial candidate for 3D printing of bone implants. From 48hours to a few days after injection, diffuse facial edema of varying severity is the most common persistent reaction (Figure3), with reduced induration and usually without erythema. At 12 months the efficacy outcomes on GAIS showed improvement in 90% and 91.4% of patients, respectively. 3D bioprinting and the current applications in tissue engineering. All the treatments reviewed in the present article were carried out by a single boardcertified dermatologist in his private practice. Interestingly, PCL is a known polymer belonging to the aliphatic polyesters, extensively investigated and used; it presents the advantage of a slower degradation than polylactic acid (PLLA) or polyglycolic acid (PGA), which both belong to the same chemical family.6,7. Its safety has been investigated in clinical studies and vigilance surveys. All five patients were instructed to wait another 2weeks before seeking any further intervention, and all of the palpable but nonvisible lumps had resolved without any intervention 2weeks after the time of the report. Treatment options for dermal filler complications. Overcorrection should be avoided. Zhang ZZ, Wang SJ, Zhang JY, et al. Intralesional microinjection of corticosteroids (various can be used) is the standard treatment in case of non-response to massage or with later onset. sharing sensitive information, make sure youre on a federal Semin Plast Surg. Hyaluronic acid-based products simply improve volume in the short-term. The copolymer of polycaprolactone and polyglycolide enters into the composition of the well-known monofilament suture Monocryl (Ethicon, Inc.; Somerville, New Jersey, USA), widely used in several surgery fields for many years.23 It maintains high tensile strength and induces minimal tissue reaction after implantation in favor of its safety. Guarino V, Gentile G, Sorrentino L, Ambrosio L. Polycaprolactone: synthesis, properties, and applications. Subdermal filler injections can volumize and treat wrinkles but cannot directly change dermal thickness. Bezwada RS, Jamiolkowski DD, Lee IY, et al. Finally, the most severe immediate-onset reactions of dermal fillers are vascular impairment events, reported at an extremely low rate for dermal fillers but that are devastating. J Control Release. 2016;40(4):549555. A collagen (CG) gel was combined without and with an electrospun . The author declares no conflicts of interest. These adverse events include but are not limited to infection, minimal acute inflammatory tissue reaction (redness, swelling, rash, oedema, erythema, lumps/nodules etc. Reinke JM. At each point, 0.1mL was injected, associated with mechanical disruption using a 22G cannula. Please enable it to take advantage of the complete set of features! J Drugs Dermatol. 2020 The Author(s). In skin collagen type-I (85%) and type-III (10%) are predominant. DeLorenzi C. Complications of injectable fillers, part 2: vascular complications. Historically, the successive dermal fillers made available were all designed to provide improved safety and longer action duration: collagens (with safety problems) and free hyaluronic acids (disappearing very rapidly in vivo, as collagens), cross-linked hyaluronic acids (with improved duration) and collagen stimulators (with the longest action duration). In one analysis of cases induced by dermal fillers, one case of xanthelasmalike reaction using PCLbased filler was cited, showing that this is an extremely rare reaction. 2018;90:169190. 2022 Jan 3;14(1):182. doi: 10.3390/polym14010182. Its safety has been investigated in clinical studies and vigilance surveys. Figueiredo VM. 103. Christen MO, Meadows J Ellans: science and safety update. Keywords: The efficacy of polycaprolactone filler injection on enlarged facial
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