Instructions for Use
COATED, BRAIDED SILK SUTURE
NONABSORBABLE SURGICAL SUTURES, U.S.P.
Description
SILK is nonabsorbable steril e, surgical suture composed of an organic protein called fibroin. This protein is derived
from the domesticated species Bombyx mori (B. mori) of the family Bombycidae. SILK sutures are processed
to remove the natural waxes and gums. SILK suture is dyed black and coated uniformly with silicone to reduce
capillarity, and to increase surface lubricity, to enhance handling, ease passage through tissue and knot run-down
properties. SILK sutures are dyed black with Logwood extract to enhance visibilit y in tissue.
SILK meets all requirements established by the United States Pharmacopeia (U.S.P.) for Nonabsorbable Surgical
Suture.
Indications
SILK is indicated for use in general soft tissue approximation and/or ligat ion, including’ use in cardiovascular,
ophthalmic and neurological procedures.
Actions
SILK elicits an acute inflammatory re action in tissues, which is followed by gradual encapsulation of the suture
by fibrous connective tissue. While SILK is not absorbed, progressive degradation of the proteinaceous silk fiber
in-vivo may result in gradual loss of all of the suture’s tensile strength within one year.
Contraindications
The use of this suture is contraindicated in pat ients with known sensiti vities or allergies to silk. Due to the gradual
loss of tensile strength, which may occur over prolonged periods in-vivo, SILK should not be used where permanent
retention of tensile strength is required, as in fixation of vascular prostheses.
War ning s
Do not resterilize. Discard open, unused sutures.
Prolonged contract of this or any other suture with salt solutions, such as those found in urinary or biliary tracts,
may result in calculus formation.
Users should be familiar with surgical procedures and techniques involving nonabsorbable sutures before
employing SILK for wound closure, as risk of wound dehiscence may vary with the si te of application and the suture
materia l used.
As any foreign material in the presence of bacterial contamination may enhance bacterial infectivity, acceptable
surgical practice must be followed with respect to drainage and closure of infected or contaminated wounds.
Precautions
In handling this or any other suture materia l, care should be taken to a void damage from handling. Avoid crushing
or crimping damage due to application of surgical instruments such as forceps or needle holders.
As with any suture material, adequate knot security requires the accepted surgical technique 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 part icularly appropriat e when knotting monofilaments.
Adverse Reactions
Adverse effects associated with the use of this device include: wound dehiscence, gradual loss of all tensile
strength over time, allergic response in patients that are known to be sensitive to silk, calculi format ion in urinary
and biliary tracts when prolonged contact wi th salt solutions such as urine and bile occurs, enhanced bacterial
infectivi ty, acute inflammatory tissue reaction, and pain, edema, and erythema at the wound site.
How Supplied
SILK sutures are available dyed black with Logwood extract and uniformly coated with silicone, in U.P.S. sizes 3-0
through 4-0 (metric s izes 0.3 - 5.0) in a variet y of lengths, with permanently attached needles. These sutures are
supplied sterile in one dozen boxes.
CAUTION
Federal (USA) law restricts this device t o sale by or on the order of a dentist or physician.
Manufactured for:
Miltex, Inc.
589 Davies Drive
York, PA 17402 USA
800-645-8000
www.miltex.com
Copyright © 2010 Integra LifeSciences Corporation
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