CE Marked injectable medical device (Pluryal Silk listed with CE 0373 in Pluryal injectables summary).
Manufactured in Europe under an ISO 13485 Certified quality management system for medical devices.
Production carried out according to Good Manufacturing Practice (GMP) standards for sterile injectable products.
CE Marked injectable medical device (Pluryal Silk listed with CE 0373 in Pluryal injectables summary).
Manufactured in Europe under an ISO 13485 Certified quality management system for medical devices.
Production carried out according to Good Manufacturing Practice (GMP) standards for sterile injectable products.
Formulation and manufacturing processes designed to ensure sterility, pyrogen Free status and biocompatibility of polynucleotide gels.
Part of the Pluryal Densifiers range, supported by ex vivo and clinical trials demonstrating increased collagen density in the dermis and improved peri Orbital skin appearance.
Description
Pluryal Silk 2ml is a polynucleotide-based dermal filler and skin densifier from the Pluryal Densifiers range, designed to rejuvenate and repair delicate areas of the face and body, particularly the eye contour, peri-oral region and thin skin. Composed of highly purified polynucleotides in an isotonic injectable gel, it works by ‘densifying’ the skin: stimulating fibroblast activity, boosting collagen and elastin production, and improving hydration, elasticity and firmness. Pluryal Silk is used to smooth fine lines around the eyes and mouth, improve skin texture and tone, reduce signs of fatigue, and help reduce acne scars and stretch marks (including postpartum stretch marks on the abdomen and other body areas). The product is supplied as 2 ml total volume with needles, and is injected intradermally in the mid to deep dermis.
Bnefits
Improves skin hydration and elasticity due to a high purity of polynucleotides that bind water and support dermal matrix function.
Densifies and tightens the skin by stimulating fibroblasts and boosting collagen and elastin production.
Reduces signs of ageing and fatigue, particularly fine lines and crepey skin around the eye contour and peri-oral area.
Improves overall skin texture and firmness, leaving the skin smoother, softer and more supple.
Helps even skin tone and improves the appearance of dull, devitalised skin.
Promotes cellular regeneration and repairs the skin’s metabolism and structure in delicate facial and body areas.
Reduces the appearance of acne scars and postpartum or other stretch marks when used in appropriate protocols, often in combination with EBD or peeling treatments.
Acts as a ‘skin healer’ and is presented as an ideal alternative or complement to traditional fillers and botulinum toxin for fine lines in certain indications.
Minimally invasive with short downtime and natural-looking results when performed by trained injectors.
Part of the Pluryal Densifiers family of polynucleotide-based injectables, supported by ex vivo and clinical data on improved collagen density and peri-orbital skin appearance.
Indications
Aggressed or tired skin requiring repair of texture and colour.
Formulation and manufacturing processes designed to ensure sterility, pyrogen Free status and biocompatibility of polynucleotide gels.
Part of the Pluryal Densifiers range, supported by ex vivo and clinical trials demonstrating increased collagen density in the dermis and improved peri Orbital skin appearance.
Fine lines and early signs of ageing on the face, especially around the eyes and mouth.
Peri-orbital area: eyelids, dark circles, crow’s feet, lower eyelid region.
Peri-buccal area: fine lines around the mouth, smoker’s lines, perioral wrinkles.
Neck and décolletage: thin, fragile skin with loss of elasticity and texture irregularities.
Face in general for improved hydration, elasticity and tone.
Hands and body areas with stretch marks or skin laxity (e.g. abdomen including postpartum stretch marks, chest, inner thighs, buttocks).
Acne scars and other superficial textural irregularities, often in combination with adjunctive treatments (e.g. peels, EBD).
Skin preparation and biorevitalisation prior to other aesthetic procedures (e.g. lasers, peels, fillers) where improved skin quality is desired.
Composition
Polynucleotides 7.5 mg/ml (15 mg per 2 ml total): highly purified, natural DNA fragments of fish origin (e.g. salmon), fully biodegradable and biocompatible, with trophic effects on fibroblasts.
Isotonic gel vehicle including: water for injections, sodium chloride, sodium monohydrogen phosphate dihydrate and sodium dihydrogen phosphate dodecahydrate (buffered solution).
No added lidocaine; analgesia is managed separately according to clinic protocol.
Formulation
Sterile, pyrogen-free, viscoelastic isotonic gel for intradermal injection.
Polynucleotide concentration: 7.5 mg/ml (denoted as PNs or PDRN-like polynucleotides).
Non-cross-linked injectable biostimulatory gel, not a traditional BDDE-crosslinked HA filler.
Designed for mid to deep dermal injection using fine needles (e.g. 27G or 30G), depending on area and technique.
Presented in a pre-filled glass syringe, ready for use after aseptic needle attachment.
Packaging
LPG Clinics presentation: pack contains 2 x 1 ml pre-filled syringes (total 2 ml) and 2 needles 27G x 1/2" (13 mm).
Pluryal official injectables overview: Pluryal Silk packaging described as 2 x 1.1 ml syringes (marketed as 2 ml total) with CE 0373 marking.
Sterile blister packaging with outer carton labelled with product name, batch number, lot, and expiry date.
Single-patient, single-use medical device with traceability labels included for patient records.
Usage
Pluryal Silk is a medical injectable device and must only be used by appropriately trained and qualified healthcare or aesthetic practitioners experienced in intradermal injection of polynucleotide gels.
Before treatment, perform a full medical history and examination, identify indications (e.g. peri-orbital fine lines, peri-oral lines, acne scars, stretch marks), and rule out contraindications. Obtain informed consent and document baseline appearance.
Cleanse and disinfect the treatment area thoroughly. Apply topical anaesthetic if needed, according to clinic protocol.
Attach a sterile 27G or 30G needle to the pre-filled syringe under aseptic conditions and expel any air bubbles before injection.
Recommended injection level (per Pluryal injectables summary): mid to deep dermis. Adjust depth depending on area (more superficial in very thin skin, slightly deeper in thicker areas).
Use suitable injection techniques such as microbolus (microdroplet), linear threading, fanning or cross-hatching, following manufacturer training guidance and the anatomy of the treatment area.
Typical treatment protocol described by distributors: 3 to 5 sessions spaced 1–2 weeks apart (e.g. every 14 days) for an initial course, depending on indication and skin condition.
Maintenance: repeat treatment cycle or perform single maintenance sessions approximately every 3–6 months to maintain results; some wholesalers also reference visible result longevity of around 2–3 months without ongoing maintenance.
Indicated treatment zones include: eye contour (periorbital region), face, peri-oral area, neck, décolletage, hands and selected body areas with stretch marks or lax skin; adapt dose and technique to thickness and sensitivity of each area.
Inject slowly with minimal pressure, aspirating where appropriate and constantly monitoring for pain, blanching or other signs of vascular compromise. Stop immediately and follow standard emergency protocols if vascular events are suspected.
After injection, gently smooth the treated area if necessary; avoid aggressive massage that could displace the product or increase bruising.
Provide post-treatment advice: avoid makeup on treated areas for several hours; avoid intense heat/cold (sauna, steam room, sunbeds), strenuous exercise and alcohol for 24 hours; protect treated zones from UV exposure with broad-spectrum sunscreen.
Schedule follow-up appointments to evaluate response and decide on further sessions or maintenance, documenting lot numbers, injected volumes and any adverse events carefully.
Always refer to the latest official Pluryal Silk professional documentation and injectables summary from MD Skin Solutions for detailed, updated guidance on indications, techniques, protocols and safety.
Contraindications
Hypersensitivity or known allergy to polynucleotides or any excipients in the formulation (e.g. buffer components).
History of severe allergic reactions or anaphylaxis to injectable biostimulators or similar products.
Active skin infections, inflammatory conditions or lesions at or near the intended injection sites (e.g. bacterial infection, herpes simplex, dermatitis).
Autoimmune diseases or immunodeficiency disorders where injectable biostimulators may be inadvisable, unless assessed and cleared by a specialist.
Known tendency to hypertrophic or keloid scarring in the proposed treatment area.
Bleeding disorders or current significant anticoagulant/antiplatelet therapy that increases bleeding risk, unless evaluated and approved by a prescribing physician.
Pregnancy and breastfeeding, which are commonly regarded as contraindications or strong precautions for elective aesthetic injectable procedures.
Severe systemic illness or uncontrolled chronic disease where non-essential aesthetic procedures are inappropriate.
Any additional contraindications or warnings specified in the official Pluryal Silk Instructions for Use and local regulatory or professional guidelines.
Adverse Effects
Typical transient injection-site reactions such as redness, swelling, tenderness, pain, warmth, itching, bruising or slight bleeding.
Small nodules, papules or irregularities at injection points that usually resolve as oedema subsides and the gel integrates into the dermis.
Temporary asymmetry or contour irregularities immediately after treatment, which generally improve as swelling decreases or with subsequent adjustment.
Local hypersensitivity or inflammatory reactions, potentially presenting as prolonged erythema, swelling, induration or discomfort; these should be evaluated and managed by a clinician.
Risk of infection at injection sites if aseptic technique is not strictly followed, requiring appropriate medical treatment.
As with all injectable dermal products, very rare but serious complications related to inadvertent intravascular injection or vascular compromise are possible, potentially leading to ischaemia, necrosis or, in high-risk areas, visual disturbances; these situations require immediate recognition and emergency management according to established filler/biostimulator complication algorithms.
Any other adverse reactions described in the official Pluryal Silk professional documentation and injectables summary, which practitioners must review before use.
Storage Conditions
Store at controlled room temperature as indicated on the packaging, typically between 2°C and 25°C.
Protect from direct sunlight and do not expose to excessive heat or freezing; do not freeze the product.
Keep syringes in their original blister and outer carton until use to maintain sterility and traceability.
Do not use if the packaging, blister, syringe or needle is damaged or if sterility appears compromised.
Do not use after the expiry date printed on the package.
Discard any remaining product after use; Pluryal Silk syringes are intended for single-patient, single-use only.
Duration
Distributor and clinic information generally report results lasting up to about 6 months when treatment is repeated every 6 months; some wholesalers specify visible improvements lasting approximately 2\u20133 months with regular maintenance, with actual duration varying according to age, skin condition, lifestyle and injection technique.
Onset
Improved hydration, texture and a fresher appearance are often noticeable within days to weeks after treatment; fine lines and skin density typically show progressive improvement over the course of 3\u20135 sessions, with cumulative and long-lasting effects when maintenance is performed.
