MONOPLENE  POLYPROPYLENE SUTURE
NONABSORBABLE SURGICAL SUTURE, U.S.P/ Eur.Ph./TSEK

DESCRIPTION
MONOPLENE polypropylene suture (clear or pigmented) is a monofilament, nonabsorbable, sterile surgical suture composed of an isotactic crystalline stereoisomer of polypropylene, a synthetic linear polyolefin. The suture is pigmented blue (C.I.-color index no. 73000) or black  to enhance visibility.

INDICATIONS
MONOPLENE suture is indicated for use in general soft tissue approximation and /or ligation, including use in cardiovascular, ophthalmic, and neurosurgical procedures. MONOPLENE suture is for single use only.

ACTIONS
MONOPLENE suture elicits a minimal acute inflammatory reaction in tissue, which is followed by gradual encapsulation of the suture by fibrous connective tissue. MONOPLENE suture is not absorbed, nor is it subject to degradation or weakening by the action of tissue enzymes. As a monofilament, MONOPLENE suture, resists involvement in infection and has been successfully employed in contaminated and infected wounds to eliminate or minimize later sinus formation and suture extrusion. The lack of adherence to tissues has facilitated the use of MONOPLENE suture as a pull-out suture.

CONTRAINDICATIONS
None known.

WARNINGS
Users should be familiar with surgical procedures and techniques involving nonabsorbable sutures before employing MONOPLENE suture for wound closure, as risk of wound dehiscence may vary with the site of application and the suture material used.
Do not resterilize. Discard opened packages and unused sutures.
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.
Acceptable surgical practice must be followed for the management of infected or contaminated wounds. PRECAUTIONS
In handling this 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 of single suture strands. The use of additional throws is particularly appropriate when knotting polypropylene sutures.

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, infection, minimal acute inflammatory tissue reaction, and transitory local irritation at the wound site.

HOW SUPPLIED
MONOPLENE sutures pigmented or clear, are available as sterile strands in U.S.P. sizes 11/0 thru 3 (metric sizes 0.1  6.0).
MONOPLENE sutures are available in a variety of lengths, with permanently attached needles.
MONOPLENE sutures are available in one, two, and three dozen boxes.

STORAGE
Store below 25oC, Keep away from, sunlight.
Protect from humidity.
Do not use after expiry date.