Frequently Asked Questions
Other questions?
Certifications
Does DURAMESH have FDA 510(K) clearance?
Yes, DURAMESH has FDA 510(K) clearance and is available for sale in the United States.
Does Mesh Suture, Inc have ISO:13485 Certification?
Yes, Mesh Suture, Inc. has a EN ISO 13485:2016 and ISO 13485 certification.
Does DURAMESH have CE Mark?
Yes, DURAMESH has CE Mark and is available for sale in the EU. It has also been registered with the MHRA and is for sale in the UK.
Technical
What size should I use?
Surgeons should rely on their training, education and surgical experience for size selection. DURAMESH complies with USP except for diameter. For further assistance, please email info@meshsuture.com.
How many knots should I tie?
Knot security requires the accepted surgical technique of at least 4 alternating throws. A fifth or sixth throw can be placed for additional security. The surgeon should also crimp each throw. The initial 2 throws can be square, surgeon's, or granny without a change in knot security. If the surgeon fails to alternate direction (or cross) the free ends of the suture creating a multiple slip knot, at least 5 throws are required to prevent knot slippage and are not recommended.
Failure to adequately secure DURAMESH can result in dehiscence and additional surgical procedures. The knot should remain buried in soft tissues, and not immediately under the dermis, to avoid palpability and possible later knot removal. The knot should NOT be placed intra-abdominally. Knot tying should be slow and deliberate to maintain the individual filaments’ integrity and avoid stripping. DURAMESH is cut with standard surgical scissors at least 3 mm from the surgical knot.
Consult the DURAMESH Instructions for Use.
Can I pass DURAMESH through itself to avoid tying a knot?
No, do not pass DURAMESH through itself to create a knot or for any other purposes.
Is DURA MESH absorbable?
DURAMESH is made of polypropylene and is non-absorbable. If you are interested in an absorbable mesh suture, please email info@meshsuture.com.
Can I use DURAMESH robotically?
Yes, each USP size of DURAMESH has a needle that fits through an 8mm trocar.
Does DURA MESH unravel when it is cut?
No, DURAMESH does not unravel when cut. Watch DURAMESH in action in this laparotomy video.
Can I use DURA MESH running or interrupted?
DURAMESH can be used either in running or interrupted suturing patterns, and with small or large bites, providing surgeons with the versatility to use their preferred suturing method.
What is the difference between DURA MESH and a standard suture?
DURAMESH has greater surface area than a standard suture, which allows it to minimize tension at the suture-tissue interface and reduce suture pull-through. With its innovative linear mesh design, DURAMESH allows fibrovascular ingrowth post-implantation unlike standard suture.
Where can I use DURAMESH?
Please consult the DURAMESH Instructions for Use for complete product information prior to use. DURAMESH non-absorbable polypropylene mesh suture is indicated for general soft tissue approximation and/or ligation in clean (CDC Class I) wounds, including tendon repair and midline laparotomy where the bowel is not entered. DURAMESH is not for use in the skin or other epithelial surfaces, cardiovascular, ophthalmic, and/or neurological procedures.
Consult the DURAMESH Instructions for Use.
Where can’t I use DURAMESH?
Please consult the DURAMESH Instructions for Use for complete product information prior to use. DURAMESH is contraindicated for and should NOT BE USED in the following applications:
- Skin and other epithelial tissues
- CDC Class IV (infected/dirty) wound
- Treatment of pelvic organ prolapse
- Treatment of stress urethral incontinence
- Intracranial surgery or spinal surgery as a dural substitute
- A sensitivity or allergy to polypropylene
Ordering
How can I order DURAMESH?
For U.S. customers: Email sales@meshsuture.com.
For customers outside the U.S., please contact your local distributor to see if they offer DURAMESH, or email info@meshsuture.com for more information.
What is the minimum order quantity?
DURAMESH can be ordered in a minimum quantity of one 5-pack which is comprised of 5 individual boxes of the same size.