| SURGEASY BRAIDED SILK |
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COATED, NONABSORBABLE SURGICAL SUTURES
DESCRIPTION:
BRAIDED BLACK SILK is 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. BRAIDED BLACK SILK sutures are processed to remove the natural waxes and gums. BRAIDED BLACK SILK suture is dyed black and coated uniformly with silicone to reduce capillarity, and to increase surface lubricity, to enhance handling, ease passage through tissue and knot run-down properties. BRAIDED BLACK SILK sutures are dyed black with Logwood extract to enhance visibiity in tissue.
BRAIDED BLACK SILK meets all requirements established by the United States Pharmacopeia (U.S.P.) for Nonabsorbable Surgical Suture.
INDICATIONS:
BRAIDED BLACK SILK is indicated for use in general soft tissue approximation and for ligation, including use in cardiovascular, ophthalmic and neurological procedures.
ACTIONS:
BRAIDED BLACK SILK elicits an acute inflammatory reaction in tissues, which is followed by gradual encapsulation of the suture by fibrous connective tissue. While BRAIDED BLACK SILK is not absorbed, progressive degradation of the proteinaceous silk fiber in-vivo may result in gradual loss of all of the suture's tensile strength within one year.
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, BRAIDED BLACK SILK should not be used where permanent retention of tensile strength is required, as in fixation of vascular prostheses.
WARNING:
Do not resterilize. Discard open, unused sutures.
Prolonged contract of this or any other suture with salt solutions, such as those found in urinary or biliary tracts, may result in calculus formation.
Users should be familiar with surgical procedures and techniques involving nonabsorbable sutures before employing BRAIDED BLACK SILK 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 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, enhanced bacterial infectivity, acute inflammatory tissue reaction, and pain, edema, and erythema at the wound site.
HOW SUPPLIED:
BRAIDED BLACK SILK sutures are available dyed black with Logwood extract and uniformly coated with silicone, in U.P.S. sizes 9-0 through 2 (metric sizes 0.3 - 5.0) in a variety of lengths, with or without permanently attached needles. BRAIDED BLACK SILK sutures are supplied sterile in one and three dozen boxes.
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