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RRS Silisorg

RRS Silisorg

RRS

Injectable Aesthetic Treatment
  • Class III CE Marked medical device for dermal implantation / mesotherapy.
  • Manufactured under European medical device regulations and quality management systems.
  • Silanol Based dermal implant with documented in vitro data supporting effects on hyaluronic acid, collagen and elastin production in human fibroblasts.
Mesotherapy / Organic Silicon Skin Booster

Description

RRS Silisorg is a CE Class III silanol-based mesotherapy medical device developed by Skin Tech Pharma Group to revitalise stressed, sagging and lax skin. It contains high-concentration organic silicon (methylsilanetriol mannuronate) in an isotonic biorevitalising buffer enhanced with polyphenols and an antioxidant (resveratrol). By stimulating fibroblasts, RRS Silisorg promotes the reorganisation and synthesis of collagen and elastin fibres, increases skin volume and firmness, and reduces the appearance of wrinkles and tissue laxity. It is designed for injection by trained professionals in body areas prone to sagging or structural weakening, such as neck, upper back, upper arms, legs, inner thighs and ankle area.

Bnefits

  • Revitalises stressed and devitalised skin by stimulating fibroblast activity and extracellular matrix renewal.
  • Promotes reorganisation and synthesis of collagen and elastin fibres, improving skin firmness and elasticity.
  • Increases skin volume in treated areas, helping to reduce the appearance of wrinkles and laxity.
  • Organic silicon supports dermal restructuring and connective tissue strengthening.
  • Polyphenols and resveratrol provide antioxidant protection, helping to combat oxidative stress in skin tissues.
  • Improves tissue tone and tension in sagging areas of the body and neck.
  • Can be used as a standalone mesotherapy treatment or to potentiate the effects of other RRS products.
  • Suitable for a wide range of treatment areas, including neck, upper back, upper arms, legs, inner thighs and ankle area.
  • Class III CE medical device with documented in vitro data showing support of hyaluronic acid, collagen and elastin production in human skin fibroblasts.

Indications

  • Stressed, devitalised or photoaged skin on the body and neck.
  • Mature, tired and sagging skin requiring firming and biorevitalisation.
  • Loss of tissue tone and elasticity in areas such as neck, upper back, upper arms, legs, inner thighs and ankles.
  • Superficial wrinkles and fine lines associated with reduced dermal support.
  • Supportive treatment in protocols targeting cellulite, skin laxity and connective-tissue weakening.
  • Adjunctive mesotherapy component in combined protocols with other RRS products for scalp, face and body, where indicated.

Composition

  • Organic Silicon (Methylsilanetriol mannuronate) 1000 mg / 5 ml
  • Biorevitalisation solution 0.25 mg / 5 ml
  • Isotonic buffer solution (Sodium Chloride, Citric Acid, Sodium Hydroxide)
  • 5 polyphenols (including resveratrol and viniferin derivatives) in the biorevitalising cocktail
  • 1 antioxidant: resveratrol

Formulation

  • Sterile, pyrogen-free Class III CE medical device based on organic silicon (silanol).
  • Injectable mesotherapy solution supplied in glass ampoules containing 5 ml each.
  • Silanol (methylsilanetriol mannuronate) as organic silicon source for connective tissue restructuring.
  • Polyphenol and antioxidant-enriched biorevitalising buffer to provide additional antioxidant and skin-supportive effects.
  • Isotonic aqueous solution, without added lidocaine.

Packaging

  • Box containing 12 ampoules x 5 ml each (total 60 ml).
  • Each ampoule is single-use, sterile and intended for one session/patient as per protocol.
  • Outer carton labelled with product name, batch number, expiry date and CE Class III marking.
  • Professional Instructions for Use (IFU) included in the packaging.

Usage

  • For professional use only; RRS Silisorg must be administered exclusively by a qualified physician or suitably trained medical professional in an appropriate clinical setting.
  • Inspect outer packaging and ampoules before use; do not use if the protective packaging is damaged or if there is visible leakage or particulate matter.
  • Check the expiry date on ampoules and packaging; do not use expired product.
  • Cleanse and disinfect the treatment area according to aseptic technique guidelines.
  • Inject into the dermis or superficial subcutaneous tissue using a 30G or 32G needle, bevel down, following recommended mesotherapy techniques (e.g. microdeposit or nappage).
  • Average recommended volume: approximately 5 ml per treatment area, as per the chosen protocol and patient needs.
  • Initial treatment course: 4–6 sessions, one session per week.
  • Maintenance: booster courses can be repeated approximately every 4 months, 1–3 times per year depending on skin maturity and clinical response.
  • Indicated treatment areas include neck, upper back, upper arms, legs, inner thighs and ankle area; may also be used on other body or scalp areas as part of tailored protocols.
  • Do not reuse opened ampoules; discard any unused solution after each session.
  • Dispose of all ampoules, needles and syringes in appropriate sharps containers according to local regulations.

Contraindications

  • Known hypersensitivity or allergy to organic silicon (methylsilanetriol mannuronate), resveratrol, other polyphenols or any excipient in the formulation.
  • Active skin infections, inflammatory dermatoses or open wounds in the intended treatment area.
  • History of severe allergic reactions or anaphylaxis to injectable mesotherapy products.
  • Uncontrolled diabetes, significant systemic illness or conditions that impair wound healing, unless carefully assessed by the treating physician.
  • Autoimmune diseases or patients under immunosuppressive therapy, unless the risk–benefit profile is specifically evaluated and accepted.
  • Patients with a history of acute rheumatic fever, endocarditis or recurrent angina, as noted in device IFU precautions.
  • Use in pregnancy or breastfeeding is not recommended due to lack of specific safety data.
  • Use in children or adolescents under 18 years of age.
  • Do not inject into blood vessels, bones, tendons, muscles, ligaments or organs other than skin and superficial subcutaneous tissue.
  • In cases of existing permanent implants in the area, the manufacturer recommends transdermal use only (e.g. roller protocols) rather than injection.

Adverse Effects

  • Transient injection-site reactions such as redness, swelling, tenderness, pain, itching or small papules are common and usually resolve spontaneously.
  • Bruising or haematomas may occur, especially in patients on anticoagulant or antiplatelet medication.
  • Temporary induration, nodules or unevenness at injection sites, generally resolving with time or gentle massage.
  • Rarely, infection or abscess formation at the injection site requiring medical treatment.
  • Hypersensitivity or allergic reactions, which may present as persistent erythema, oedema, pruritus or induration.
  • Very rare but serious complications if inadvertently injected intravascularly, including vascular compromise and tissue necrosis; these require immediate emergency management.
  • Post-inflammatory hyperpigmentation in predisposed individuals if aftercare is not properly followed.

Storage Conditions

  • Store between 2°C and 35°C, as indicated in the IFU.
  • Do not expose to direct light; keep ampoules in the original carton until use.
  • Do not freeze and do not heat the product.
  • Use immediately after opening an ampoule; do not re-sterilise or reuse any leftover solution.
  • Keep out of the reach of children.

Duration

Typical protocol involves 4\u20136 initial weekly sessions. To maintain results, booster treatment cycles are recommended approximately every 4 months (1\u20133 times per year), with exact frequency adjusted according to individual skin condition and maturity.

Onset

Clinical revitalisation and improved tissue tone generally become noticeable after the initial course of 4\u20136 weekly treatments, with some patients perceiving increased firmness and skin vitality earlier. Continued improvement may be observed over subsequent weeks as collagen and elastin restructuring progresses.

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