Integra LifeSciences Sutures, Coated, Braided Polygycolic Acid, Absorbable - Manual

COATED, BRAIDED POLYGYCOLIC ACID SUTURE
ABSORBABLE SURGICAL SUTURES, U.S.P.
Description
PGA suture is a synthetic absorbable braided sterile, surgical suture composed of homopolymers of glycolide
(100%).
PGA sutures are dyed with D&C violet # 2 and coated. PGA sutures are also available un-dyed (white).
PGA meets all requirements established by the United States Pharmacopeia (USP) 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 cardiovascular and neurological procedures.
Actions
PGA 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 PGA
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 PGA retains approximately 70%
of its original tensile strength at two weeks post implantation, with approximately 30% remaining at three weeks.
Absorption of PGA 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.
Warnings
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
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 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
Instructions for Use