SENTESORB POLYGLYCOLICACID (PGA) SUTURE
ABSORBABLE, SURGICAL, BRAIDED, SYNTHETIC SUTURES,  USP/EP/TSEK

DESCRIPTION
SENTESORB Surgical Polyglycolic acid (PGA) suture; synthetic, sterile, absorbable, is  homopolymer of glycolic acid. The chemical formulation is; C21 H15 O3 C28 H22 O2 N2.
Sentesorb,  is coated with newly developed coating material (US Patent # 5609609 3/11/97); involving the mixture of calcium stearate (C36H70CaO4), polycaprolactone and sucrose fatty acid esters
The suture and coating materials are inert, noncollagenous, nonantigenic, and non-pyrogenic.
Coloured violet (Antraquinone dye-Solvent violet 13 D&C Violet no.2 C.I. 60725) to enhance visibility in tissue.
INDICATIONS
SENTESORB suture is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures. SENTESORB suture is for single use only.
ACTIONS
PGA suture elicits a minimal acute inflammatory reaction in tissue and ingrowth of fibrous connective tissue. Progressive loss of tensile strength and eventual absorption of PGA suture occurs by means of hydrolysis gradually and decreases the strength in the the body. After hydrolysis its executed from the body as carbon dioxide and water. Absorption begins as a loss of tensile strength followed by a loss of mass. PGA suture retains approximately 75% of the original tensile strength at two weeks post implantation. At three weeks, approximately 50% of the original strength is retained for sizes 6-0 and larger, and approximately 40% of its original strength is retained for sizes 7-0 and smaller. All of the original tensile strength is lost between four and five weeks post implantation. In 100 days it is totally absorbed.
CONTRAINDICATIONS
This suture, being absorbable, should not be used where extended approximation of  tissue is required.
WARNINGS
Skin sutures which must remain in place longer than 7 days may cause localized irritation and should be snipped off or removed as indicated.
Under some circumstances, notably orthopaedic procedures, immobilization of joints by external support may be employed at the discretion of the surgeon.
Consideration should be taken in the use of absorbable sutures in tissues with poor blood supply, as suture extrusion and delayed absorption may occur. Users should be familiar with surgical procedures and techniques.
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.  Do not desterilize. Discard open packages and unused sutures.
PRECAUTIONS
Skin sutures which must remain in place longer than 7 days may cause localized irritation and should be snipped off or removed as indicated. Under some circumstances, notably orthopaedic procedures, immobilization of joints by external support may be employed at the discretion of the surgeon.
Consideration should be taken in the use of absorbable sutures in tissues with poor blood supply, as suture extrusion and delayed absorption may occur.
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.
PGA sutures, which are treated to enhance handling characteristics, requires the accepted surgical technique of flat and square ties with additional throws as warranted by surgical circumstance and the experience of the surgeon.
Avoid prolonged exposure to elevated temperatures.
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 conditions which may delay wound healing, infection minimal acute inflammatory tissue reaction, localized irritation when skin sutures are left in place for greater than 7 days suture extrusion and delayed absorption in tissue with poor blood supply, calculi formation in urinary and biliary tracts when prolonged contact with salt solutions such as urine and bile occurs, and transitory local irritation at the wound site.
HOW SUPPLIED
SENTESORB sutures are available  braided, dyed (violet) strands in sizes 10-0 thru 4 (metric sizes 0.2  6.0), in a variety of lengths, with a variety of needles. SENTESORB sutures are available in one, two, and three dozen boxes. SENTESORB suture is supplied sterile.
STORAGE
Store below 25oC, Keep away from, sunlight. Protect from humidity.
Do not use after expiry date.