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ADDENDUM THREE P/N 03-3318R6
SILK SUTURE - Non-Absorbable Surgical Suture, USP 2-0 Braided, Black
Description
Silk suture (Black, White) is a non-absorbable, sterile, surgical suture composed of an
o
rganic protein called fibroin. This protein is derived from the domesticated species
Bombyx mori, (B. mori) of the family Bombycidae. In the United States, Silk suture is
provided dyed (black) or undyed (white). The pigment for the black dyed suture is
Hematein (Logwood Tree) Black. Silk suture is coated with fully refined paraffin. Silk
suture is available as either braided or twisted monofilament strands. The product meets
all the requirements established by the United States Pharmacopeia (USP) for
Non-absorbable Surgical Suture.
R
x Only
Indications
Silk suture is indicated for use in general soft tissue approximation and/or ligation,
including use in ophthalmic procedures.
Actions
Silk suture elicits an acute inflammatory reaction in tissues, which is followed by gradual
encapsulation of the suture by fibrous connective tissue. While Silk suture is not
absorbed, progressive degradation of the proteinaceous silk fiber in vivo
may result in
gradual loss of the suture's tensile strength over time.
Contraindictions
The use of this suture is contraindicated in patients with known sensitivities or allergies to
Silk. Due to the gradual loss of tensile strength which may occur over prolonged periods
in vivo
, Silk suture should not be used where permanent retention of tensile strength is
required.
Warnings
Do not resterilize. Discard open, unused sutures and associated surgical needles. Do
not reuse. Do not use if package is damaged.
Users should be familiar with surgical procedures and techniques involving Silk sutures
before employing Silk sutures, for wound closure, as risk of wound dehiscence may vary
with the site of application and the suture materiel used. Physicians should consider the
in vivo
performance (under ACTIONS section) when selecting a suture for use in patients.
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 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.
Acceptable surgical practice should be followed with respect to drainage and closure of
infected or contaminated wounds.
Caution: Refer to accompanying documents.
Proofed by: Date:
Dimensions checked: Copy checked:
RC041264
McGaw Park, IL
Richard Cisneroz
04-05-12
361-26801
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