| SURGEASY POLYPROPYLENE |
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NONABSORBABLE SURGICAL SUTURES
DESCRIPTION:
POLYPROPYLENE is nonabsorbable sterile, surgical suture (pigmented) composed of Polypropylene, a synthetic linear polyolefin. The suture is pigmented blue to enhance visibity in tissue.
POLYPROPYLENE meets all requirements established by the United States Pharmacopeia (USP) for Nonabsorbable Surgical Suture.
INDICATIONS:
POLYPROPYLENE is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
ACTIONS:
POLYPROPYLENE elicits a minimal acute inflammatory reaction in tissues, which is followed by gradual encapsulation of the suture by fibrous connective tissue. POLYPROPYLENE is not absorbed, nor is any significant change in tensile retention known to occur in-vivo.
CONTRAINDICATIONS:
None Known.
WARNING:
Do not resterilize. Discard open, unused sutures.
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 nonabsorbable sutures before employing POLYPROPYLENE 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, 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, and pain, edema, and erythema at the wound site.
HOW SUPPLIED:
POLYPROPYLENE sutures are available sterile, dyed with Copper Phthalocyanine blue 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. POLYPROPYLENE sutures are available in one and three dozen boxes.
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