Description

PGA suture  is a synthetic absorbable sterile surgical suture composed of homopolymers of glycolide (100%). PGA suture is undyed or dyed violet with D&C violet #2 and coated. PGA  meets all requirements established by the United States Pharmacopeia (U.S.P.) for synthetic absorbable surgical sutures.

Indications

PGA  is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures.

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PGA  elicits 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  PGA synthetic absorbable suture occurs by means of hydrolysis, where the polymer degrades to either glycolic acid or glycolic and lactic acids which are 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  PGA retains approximately 73% of its original tensile strength at two weeks post implantation, with approximately 33% remaining at three weeks. Absorption of  PGA synthetic absorbable surgical suture is essentially complete between 60 and 90 days.

Contraindications

This suture, being absorbable, should not to be used where extended approximation of tissue is required.

Warnings

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 absorbable sutures before employing PGA 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 contaminated or infected wounds. The use of this suture may be inappropriate in   elderly, malnourished, or debilitated patients, or in patients  suffering from cancer, anemia, obesity, diabetes, infection, or other 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 the abdomen, chest, joints, or other sites which may undergo expansion, stretching, or distension, 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 irritation and should be snipped off or remove 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 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 Reactions

Adverse effects associated with the use of this device include wound dehiscence, failure to provide adequate 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 cancer, anemia, obesity, diabetes, infection, or other conditions which may delay wound healing, enhanced bacterial infectivity, 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 erythema at the wound site.

How Supplied

PGA synthetic absorbable suture is available in sizes U.S.P. 6-0 through 2 (metric sized 0.7-3.0). The suture is supplied sterile in “pre-cut” lengths (non-needled) or attached to various needle types in one dozen boxes.

Figures In U.S.P Standard:

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