| SURGEASY MONO NYLON |
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NONABSORBABLE SURGICAL SUTURES, U.S.P.
DESCRIPTION:
MONOFILAMENT NYLON is a nonabsorbable, sterile surgical monofilament suture composed of the long-chain aliphatic polymers Nylon 6 and 6,6. MONOFILAMENT NYLON sutures are dyed black or blue to enhance visibility in tissue.
MONOFILAMENT NYLON meets all requirements established by the United States Pharmacopeia (U.S.P.) for Nonabsorbable Surgical Suture.
INDICATIONS:
MONOFILAMENT NYLON is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
ACTIONS:
MONOFILAMENT NYLON elicits a minimal acute inflammatory reaction in tissue, which is followed by gradual encapsulation of the suture by fibrous connective tissue. While it is not absorbed, progressive hydrolysis of the nylon in-vivo may result in gradual loss of up to 20% of its tensile strength per year.
Contraindications:
Due to the gradual loss of tensile strength, which may occur over prolonged periods in-vivo, MONOFILAMENT NYLON should not be used where permanent retention of tensile strength is required, as in fixation of intraocular lenses or synthetic vascular grafts.
Warnings:
Do not resterilize. Discard open, unused suture.
Prolonged contract of this or any other suture with salt solutions, such as those found in the urinary or biliary tracts, may result in calculus formation.
Users should be familiar with surgical procedures and techniques involving nonabsorbable sutures before employing MONOFILAMENT NYLON for wound closure, as risk of wound dehiscence may vary with the site of application and the suture material used.
As any foreign material in the presence of bacterial contamination may enhance bacterial infectivity, acceptable surgical practice must be followed with respect to drainage and closure of infected or contaminated wounds.
Precautions:
In handling this or any other suture material, care should be taken to avoid damage from handling. Avoid crushing or crimping damage due to application of surgical instruments such as forceps or needle holders.
As with any suture material, adequate knot security requires the accepted surgical technique of flat, square ties, with additional throws as warranted by surgical circumstance and the experience of the surgeon. The use of additional throws may be particularly appropriate when knotting monofilaments.
Adverse Reactions:
Adverse effects associated with the use of this device include: wound dehiscence, gradual loss of tensile strength over time, calculi formation in urinary and biliary tracts when prolonged contact with salt solutions such as urine and bile occurs, enhanced bacterial infectivity, minimal acute inflammatory tissue reaction, pain, edema and erythema at the wound site.
How Supplied:
MONOFILAMENT NYLON sutures are available as sterile, monofilament strands in U.S.P. sizes 6-0 through 2 (metric sizes 0.7 - 5.0) in a variety of lengths, with or without permanently attached needles. MONOFILAMENT NYLON sutures are available in one and three dozen boxes.
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