DemeSILK ™ Multifilament (Non-absorbable)

Suture Material

DemeTECH Silk Nonabsorbable Suture is a nonabsorbable, sterile, 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. The braided sutures with or without attached needles,. The product is available in several suture lengths and attached needle types. DemeTECH Silk Nonabsorbable Suture meets all requirements established by the United States Pharmacopeia for Nonabsorbable Surgical Sutures.

INTENDED USE

The DemeTECH Nonabsorbable Silk Suture with and without needles is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures. Product is intended for long term use over 30 days.

ACTIONS

The DemeTECH Silk Nonabsorbable Suture elicits an acute inflammatory reaction in tissues, which is followed by gradual encapsulation of the suture by fibrous connective tissue. While DemeTECH Silk Nonabsorbable Suture 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. The DemeTECH Silk Nonabsorbable Suture is available in various sizes. The suture is supplied sterile in pre-cut lengths both with and without affixed needles of various straight and curved needle types and supplied in cartons of one dozen.

Characteristics

DemeTech’s Silk suture is a non-absorbable, sterile, surgical suture composed of an organic protein called fibroin. DemeTech’s silk sutures are processed to remove the natural waxes and gums from its origin. As Silk is a natural fiber, it does illicit an acute inflammatory reaction, which is followed by gradual encapsulation of the suture by fibrous connective tissue (occurring usually in 14-21 days). While DemeTech’s silk sutures are not considered absorbable sutures, progressive degradation of its fibers results in the gradual loss of tensile strength within the first year.

• 1 Raw silk is produced by a silkworm larva’s cocoon. These natural waxes and gums are removed prior to the braiding process, allowing fora tighter, more compact braid.
• 2 DemeTech’s Silk suture is dyed black for easier visibility in tissue.
• 3 DemeTech’s Silk suture is non-absorbable and multifilament in nature.
• 4 Although DemeTech classifies its silk suture as a non-absorbable suture, it loses most of its tensile strength in one year.

WARNINGS:

• 1 Do not resterilize. Discard open, unused sutures.
• 2 Prolonged contact of this or any other suture with salt solutions, such as those found in the urinary of biliary tracts, may result in calculus formation.
• 3 Users should be familiar with surgical procedures and techniques involving nonabsorbable sutures before employing the DemeTECH Silk Nonabsorbable Suture for wound closure, as risk of wound dehiscence may vary with the site of application and the suture material used.
• 4 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.
• 5 Do not reuse. The reuse of single-use devices can cause cross contamination and affect the device safety, performance and effectiveness, exposing patients and staff to unnecessary risk. The design and material used are not compatible with conventional cleaning and sterilization procedures.

PRECAUTIONS

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. 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 particularly appropriate when knotting monofilaments.

ADVERSE REACTIONS

Adverse effects associated with the use of this device include: wound dehiscence, gradual loss of tensile strength over time, allergic response in patients that are known to be sensitive to silk, calculi formation in urinary and biliary tracts when prolonged contact with salt solutions such as urine and bile occurs, enhanced bacterial infectivity, acute inflammatory tissue reaction, pain, edema, and erythema at the wound site.

DELIVERY FORM:

The DemeTECH Silk Nonabsorbable Suture is available in sizes various sizes. The suture is supplied sterile in pre-cut lengths both with and without affixed needles of various straight and curved needle types and supplied in cartons of one dozen.