ETHILON Black Monofilament Nylon Suture 10 0 BV130 5, 30 cm (Box of 12)
ETHILON
Medical deviceNonabsorbable surgical suture (wound closure)
Certifications
- CE Marked sterile single Use medical device for wound closure (surgical suture), as supplied in European and UK markets.
- Designed and manufactured to comply with applicable ISO standards for sterile surgical sutures and single Use medical devices, as specified by Ethicon.
- Meets pharmacopoeial requirements (e.g., USP) for nonabsorbable surgical sutures for ETHILON Nylon Suture product range.
- Subject to relevant regulatory approvals or registrations for medical devices in the jurisdictions where marketed (e.g., EU/UK, FDA 510(k) clearance for the ETHILON suture family in the United States).
- CE Marked sterile single Use medical device for wound closure (surgical suture), as supplied in European and UK markets.
- Designed and manufactured to comply with applicable ISO standards for sterile surgical sutures and single Use medical devices, as specified by Ethicon.
- Meets pharmacopoeial requirements (e.g., USP) for nonabsorbable surgical sutures for ETHILON Nylon Suture product range.
- Subject to relevant regulatory approvals or registrations for medical devices in the jurisdictions where marketed (e.g., EU/UK, FDA 510(k) clearance for the ETHILON suture family in the United States).
Nonabsorbable surgical suture (wound closure)
Description
ETHILON Black Monofilament is a sterile, nonabsorbable, black nylon (polyamide) microsurgical suture in size 10-0 with a 30 cm filament, supplied with an attached BV130-5 3/8 circle taper point micro-needle. It is used for very fine soft tissue approximation and ligation, including ophthalmic, cardiovascular, neurological and other microsurgical procedures, and is supplied as a box of 12 individually packaged sutures.
Bnefits
- Nonabsorbable monofilament nylon suture designed for minimal tissue reactivity and smooth passage through tissue.
- Very fine 10-0 diameter and BV130-5 micro-needle configuration suitable for delicate microsurgery and ophthalmic procedures.
- High initial tensile strength with reliable knot security during the critical wound healing period.
- Black coloration enhances visibility of the suture against tissue.
- Monofilament construction reduces tissue drag and may reduce the risk of bacterial wicking compared with braided sutures.
- Supplied sterile and single-use in individually packaged foils for infection control.
Indications
- General soft tissue approximation and/or ligation where a nonabsorbable monofilament suture is appropriate.
- Cardiovascular soft tissue repair and anastomoses, according to surgeon preference.
- Ophthalmic surgery including corneal, scleral, and other delicate ocular tissues where very fine sutures (10-0) are required.
- Neurological and microsurgical procedures involving small vessels and delicate neural tissues.
- Plastic and reconstructive procedures, including fine skin closure in areas where precise wound edge approximation and minimal scarring are desired.
- Use in patients where a nonabsorbable suture is preferred and later removal is feasible or where a long-lasting but not necessarily permanent support is required.
Composition
- Sterile surgical monofilament suture composed of long-chain aliphatic polyamides (Nylon 6 and Nylon 6,6) or equivalent polyamide composition specified for ETHILON Nylon Sutures.
- Black dye to enhance visibility in tissue (meets applicable pharmacopoeial requirements for nonabsorbable sutures).
- Attached stainless steel atraumatic needle: BV130-5, 3/8 circle taper point micro-needle (approximately 6.5 mm needle length, for microsurgery).
Formulation
- Nonabsorbable, synthetic monofilament polyamide (nylon) suture, size USP 10-0, black.
- Length 30 cm filament with permanently attached BV130-5 3/8 circle taper point needle.
- Supplied sterile, intended for single use only.
Packaging
- Box of 12 individually packaged sterile sutures.
- Each sterile foil pack contains one ETHILON black monofilament nylon suture (USP 10-0, 30 cm) with one BV130-5 3/8 circle taper point micro-needle attached.
- Outer carton labeled with product name, size (10-0), length (30 cm), needle code (BV130-5), lot number, and expiry date.
Usage
- For use only by trained healthcare professionals experienced in surgical suturing techniques.
- Select ETHILON Black Monofilament 10-0 BV130-5 based on the specific procedure, tissue type, and required suture size as determined by the surgeon.
- Open the sterile pack immediately before use, maintaining aseptic technique; do not use if the package is opened or damaged.
- Load the BV130-5 needle securely into an appropriate needle holder, avoiding repeated bending or crushing of the needle or suture.
- Approximate tissues without excessive tension to avoid tissue ischemia or tearing, using appropriate suture patterns for the procedure.
- Tie secure knots according to standard surgical technique, taking care to avoid over-tightening in delicate tissues.
- Cut suture ends to the desired length and manage wound care according to local protocol.
- Where the suture is intended for removal (e.g., skin closure), remove at a time determined by the surgeon based on wound location, healing, and patient factors.
- Do not resterilize unused sutures; discard any opened but unused packs in accordance with local regulations.
- Follow the full Instructions for Use and package insert supplied by the manufacturer for detailed indications, contraindications, warnings, and precautions.
Contraindications
- Not recommended where permanent suture retention with maintained tensile strength is required, as nylon loses tensile strength in vivo over time.
- Avoid use in the urinary or biliary tracts where the presence of a nonabsorbable foreign body may lead to calculus formation.
- Relative contraindication in infected or heavily contaminated wounds where a nonabsorbable monofilament suture may not be the preferred choice, according to surgical judgment.
- Known hypersensitivity or allergy to nylon (polyamide) or any component of the suture or needle.
- Use with caution in patients or anatomical sites where nonabsorbable sutures are generally contraindicated.
Adverse Effects
- Local tissue inflammatory response at the suture site, typically minimal but potentially more pronounced in sensitive individuals.
- Infection at the wound or suture site, particularly if aseptic technique is not strictly followed or in contaminated wounds.
- Scar formation, hypertrophic scarring, or keloid formation depending on patient-related and wound-related factors.
- Suture extrusion, granuloma formation, or foreign-body reaction.
- Suture breakage or knot slippage, especially if improperly handled or tied.
- Allergic or hypersensitivity reactions to the suture material or associated components, although these are uncommon.
Storage Conditions
- Store in a clean, dry place at controlled room temperature, typically 15–25 °C, or within the range stated on the product packaging.
- Protect from excessive heat, moisture, and direct sunlight.
- Keep in original packaging until time of use to maintain sterility.
- Do not use the product after the expiry date printed on the packaging.
- Do not use if the sterile pack is opened, torn, or otherwise compromised; dispose of such packs according to local regulations.
- Do not attempt to resterilize any unused sutures.
Duration
Single-use surgical device; duration of tissue support and the timing of suture removal (if applicable) are determined by the surgical procedure, tissue type, and clinical judgment. While the suture is nonabsorbable, in vivo tensile strength gradually decreases over time, so it should not be used where permanent tensile support is required.
Onset
Immediate mechanical approximation and ligation of soft tissues upon correct placement and knot tying.
