SILK
NONABSORBABLE, SURGICAL SILK SUTURE, USP/ EP/TS5505

DESCRIPTION
Silk suture is a nonabsorbable, sterile, surgical suture composed of an organic protein called fibroin. This protein is derived from the domesticated species Bombyx mori (B. mori) of the family Bombycidae. Silk sutures are processed to remove the natural waxes and gums. Above USP 7/0 it is braided. USP7/0 and 8/0 are available braided or twisted. Silk suture is dyed and coated with a paraffin wax or silicone. Black dye is Hematein HCK (C.I.-color index no. 75290). SILK suture is also available in its natural color, ivory. Virgin silk suture is available in which the sericin gum is not removed and serves to hold the filaments together. Virgin silk is coloured blue by Methylene Blue (C.I.# 52015) or black by Hematein.
SILK suture meets requirements established by the United States Pharmacopoeia (U.S.P.) for Nonabsorbable Surgical Suture Monogram and the requirements of Braided Silk Suture Monogram established by European Pharmacopoeia (E.P.).
INDICATIONS
SILK suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurosurgical procedures.
Silk suture is for single use only.
ACTIONS
SILK suture elicits an acute inflammatory reaction in tissue, which is followed by a gradual encapsulation of the suture by fibrous connective tissue. While silk sutures are not absorbed, progressive degradation of the proteinaceous silk fiber in vivo may result in gradual loss of all of the suture's tensile strength over time.
CONTRAINDICATIONS
The use of this suture is contraindicated in patients with known sensitivities or allergies to silk.
Due to the gradual loss of tensile strength which may occur over prolonged periods in vivo, silk should not be used where permanent retention of tensile strength is required.
WARNINGS
Users should be familiar with surgical procedures and techniques involving nonabsorbable sutures before employing SILK suture for wound closure, as risk of wound dehiscence may vary with the Site of application and the suture material used.
As with any foreign body, prolonged contact of any suture with salt solutions, such as those found in the urinary or biliary tracts, may result in calculus formation.
Do not  resterilize. Discard opened packages and unused sutures. Acceptable surgical practice should be followed for the management of infected or contaminated wounds.
Skin sutures which remain in place for periods of longer than seven days may cause localised topical irritation and the extended portion of suture may be snipped off after five to seven days.
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 and square ties with additional throws as warranted by surgical circumstance and the experience of the surgeon.
ADVERSE REACTIONS
Adverse effects associated with the use of this device include wound dehiscence, gradual loss of all tensile strength over time, allergic response in patients that are known to be sensitive to silk, calculi formation in urinary and biliary tracts when prolonged contact with salt solutions such as urine and bile occurs, infection, acute inflammatory tissue reaction and transitory local irritation at the wound site.
HOW SUPPLIED
SILK sutures are available in U.S.P. sizes 10/0 thru 5 (metric sizes 0.2 - 7.0) in a variety of lengths and affixed to needles or non-needled.
SILK sutures are available in one, two, and three dozen boxes.
SILK suture is supplied sterile.
STORAGE
Store below 25oC, Keep away from, sunlight.
Protect from humidity.
Do not use after expiry date.

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