Polyester suture is nonabsorbable sterile
surgical suture composed of Polyethylene terephthalate. It is prepared from
fibers of high molecular weight, long-chain, polyesters having recurrent
aromatic rings as an integral component.
Suture characteristics include: braided
uncoated white (undyed) or green (DC #6 Green dyed) and braided silicone
(biologically inert, nonabsorbable) coated, white (undyed) or green (DC #6 Green
dyed).
The product meets all requirements
established by the United States Pharmacopeia (U.S.P.) for nonabsorbable
surgical sutures.
Polyester Suture is indicated for use in
general soft tissue approximation and/or ligation, including use in
cardiovascular, ophthalmic and neurological procedures.
Polyester Surgical Suture elicits a
minimal acute inflammatory reaction in tissues, which is followed by gradual
encapsulation of the suture by fibrous connective tissue. Polyester Surgical
Suture is not absorbed, nor is any significant change in tensile strength
retention known to occur in vivo.
None known.
DO NOT RESTERILIZE. 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 nonabsorbable sutures before employing Polyester 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 contaminated or infected
wounds.
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 techniques 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 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, infected wounds, minimal acute inflammatory tissue reaction, and pain, edema and erythema at the wound site.
Polyester surgical suture is available in
U.S.P. sizes 7-0 through 5 (metric 0.5 through 7). The suture is supplied
sterile in pre-cut lengths, both nonneedled and affixed to various needle types
in one dozen boxes.