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| SURGEASY BRAIDED PGA |
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ABSORBABLE SURGICAL SUTURES, U.S.P.
DESCRIPTION:
BRAIDED POLYGLYCOLIC ACID SUTURE is a synthetic absorbable braided sterile, surgical suture composed of homopolymers of glycolide (100%).
BRAIDED POLYGLYCOLIC ACID SUTURE sutures are dyed with D&C violet #2 and coated. SURGEASY BRAIDED PGA sutures are also available un-dyed (white).
BRAIDED POLYGLYCOLIC ACID SUTURE meets all requirements established by the United States Pharmacopeia (USP) for Synthetic Absorbable Surgical Sutures.
INDICATIONS:
BRAIDED POLYGLYCOLIC ACID SUTURE is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not cardiovascular and neurological procedures.
ACTIONS:
BRAIDED POLYGLYCOLIC ACID SUTURE elicits a minimal acute inflammatory reaction in tissues, which is followed by gradual encapsulation of the suture by fibrous connective tissue. Progressive loss of tensile strength and eventual absorption of BRAIDED POLYGLYCOLIC ACID SUTURE Synthetic Absorbable Sutures occurs by means of hydrolysis, where the polymer degrades to glycolic acid, which is subsequently absorbed and metabolized by the body. Absorption begins as a loss of tensile strength without appreciable loss of mass. Implantation studies in animals indicate that BRAIDED POLYGLYCOLIC ACID SUTURE retains approximately 70% of its original tensile strength at two weeks post implantation, with approximately 30% remaining at three weeks. Absorption of BRAIDED POLYGLYCOLIC ACID SUTURE Synthetic Absorbable Suture is essentially complete between 60 to 90 days.
CONTRAINDICATIONS:
This suture, being absorbable, should not be used where extended approximation of tissue is required.
WARNING:
Do not re-sterilize. Discard open, unused sutures. Store at room temperature. Avoid prolonged exposure to elevated temperatures.
As with any foreign body, prolonged contact 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 absorbable sutures before employing BRAIDED POLYGLYCOLIC ACID SUTURE Synthetic Absorbable Suture for wound closure, as risk of wound dehiscence may vary with the site of application and the suture material used.
Acceptable surgical practice should be followed with respect to drainage and closure of infected or contaminated wounds.
The use of this suture may be inappropriate in elderly, malnourished, or debilitated patients, or in patients suffering from conditions, which may delay wound healing.
As this is an absorbable suture material, the use of supplemental non-absorbable sutures should be considered by the surgeon in the closure of sites, which may undergo expansion, stretching or distention or, which may require additional support.
PRECAUTIONS:
Under some circumstances, notably orthopedic procedures, immobilization by external support may be employed at the discretion of the surgeon.
Skin sutures, which must remain in place longer than seven (7) days may cause localized in irritation and should be snipped off or removed as indicated.
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.
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, failure to provide wound support in closure of the sites where expansion, stretching or distension occur, failure to provide adequate wound support in elderly, malnourished or debilitated patients, or in patients suffering from conditions, which may delay wound healing, wound infection, minimal acute inflammatory tissue reaction, localized irritation when skin sutures are left in place for greater than seven (7) days, calculi formation in urinary and biliary tracts when prolonged contact with salt solutions such as urine and bile occurs, and pain, edema and transitory local irritation.
HOW SUPPLIED:
BRAIDED POLYGLYCOLIC ACID SUTURE are available as sterile, un-dyed (natural) or dyed with D&C violet #2 and coated uniformly, in U.S.P. sizes 6-0 through 2 (metric sizes 0.7 - 5.0), in a variety of lengths, with and without permanently attached needles. BRAIDED POLYGLYCOLIC ACID SUTURES are available in one and three dozen boxes.
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