UM-978

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Indications, Safety, and WarningsIndications
Biosyn™ sutures are indicated for use in general soft tissue approximation and/or ligation. The intended purpose of the suture is soft tissue approximation and/or ligation.ActionsBiosyn™ sutures elicit 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 Biosyn™ sutures occurs by means of hydrolysis where the suture is broken down to glycolic acid, dioxanoic acid, propane diol, and carbon dioxide which are subsequently absorbed and metabolized by the body.Absorption begins as a loss of tensile strength without appreciable loss of mass. Studies in indicate tensile strength averages for Biosyn™ sutures are approximately 75% of United States Pharmacopeia (USP) and European Pharmacopoeia (EP) minimum knot strength at two weeks and approximately 40% of USP and EP at three weeks post-implant. Absorption of Biosyn™ sutures is essentially complete between 90 and 110 days.ContraindicationsThis suture, being absorbable, should not be used where extended approximation of tissue is required. Biosyn™ sutures should not be used on cardiovascular or neural tissues.Warnings

This device is provided sterile for single-use only. Sterile unless sterile barrier system(s) has been opened or damaged. Visually inspect the package before use. Do not reuse, reprocess, or resterilize this device. Reuse, reprocessing and/or resterilization may compromise the structural integrity of the device or may create the risk of contamination, patient infection, permanent impairment or life-threatening injury.

Discard open, unused sutures in accordance with end user’s sharps containment, handling, and disposal procedures.

Dispose of used sutures in accordance with the end-user’s medical and biological waste disposal requirements. “Sharps” should be disposed of in accordance with end user’s sharps containment, handling, and disposal procedures. Use caution during handling and disposal to avoid injury.

Before employing Biosyn™ sutures for wound closure, healthcare professionals should consider the characteristics of the wound and absorption profile of the suture as the risk of wound dehiscence may vary with the site of application and the suture material used.

As with any foreign body, prolonged contact of any suture with salt solutions may result in calculus formation.

Acceptable surgical practice must be followed with respect to drainage and closure of contaminated or infected wounds.

The use of this suture may be inappropriate for patients with any conditions which, in the opinion of the surgeon, may cause or contribute to delayed wound healing.

The use of supplemental nonabsorbable sutures should be considered by the surgeon in the closure of sites subject to expansion, stretching or distention, or requiring additional support.

Suture failure may result in bleeding, wound dehiscence, or infection.

This device contains nickel that may cause allergic reaction.

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