Pending 510(k), Not available for sale within the United States
Caution: Federal law restricts this device to sale and use by, or on the order of, a physician.
DURAMESH™ is an Investigational Device. DURAMESH™ is not yet approved for sale in the Unites States. DURAMESH™ is being provided for INVESTIGATIONAL USE ONLY.
DURAMESH™ Suturable Mesh is regulated by the US Food and Drug Administration as a surgical suture.
DURAMESH™ is a sterile non-absorbable suturable mesh made from multiple polypropylene filaments. The polypropylene (blue) is a synthetic, non-absorbable monofilament, composed of isotactic polypropylene polymer. DURAMESH™ is sterilized using ethylene oxide gas. DURAMESH™ is provided dyed (blue). The pigment for the blue dye is Phthalocyaninato (2- ) Copper and is uniform in appearance.
DURAMESH™ Suturable Mesh is indicated for general soft tissue approximation and/or ligation. Its mesh body permits tissue ingrowth and incorporation.
DURAMESH™ is contraindicated for use in skin or other epithelial surfaces such as bowel, viscera or bladder mucosa.
DURAMESH™ is contraindicated for use in the treatment of pelvic organ prolapse.
DURAMESH™ is contraindicated for use in intracranial surgery or spinal surgery as a dural substitute.
DURAMESH™ is contraindicated for use in the treatment of stress urethral incontinence.
DURAMESH™ is contraindicated for use if there is a sensitivity or allergy to polypropylene.
DURAMESH™ Suturable Mesh is sterilized by ethylene oxide gas.
DURAMESH™ should be stored in a clean, dry location at room temperature in its original packaging.
DURAMESH™ Suturable Mesh is supplied sterile and is available in 2-0, 0, Number 1, and Number 2 sizes each with a length of approximately 36 inches. For the DURAMESH™ 0, Number 1, and Number 2 needles are available in two sizes, small and large. Each box contains one DURAMESH™. Each DURAMESH™ is packaged within a sterile protective medical grade outer tube. The sterile protective tube is fixed to a sterile card. The sterile needle is located underneath a protective needle flap, with the sharp tip stuck into a piece of protective foam, covered by a folded piece of medical grade paperboard.
SURGICAL EQUIPMENT REQUIRED (not included)
Sterile needle driver, sterile tray large enough to hold the sterile card, sterile surgical scissors, sterile gloves.
Animal studies show that implantation of DURAMESH™ elicits a minimal inflammatory reaction in tissues and permits the ingrowth of fibrovascular tissue. The implant is not absorbed, nor is it subject to degradation or weakening by the action of tissue enzymes.
DURAMESH™ Suturable Mesh meets performance requirements per USP as follows:
USP 871 – Sutures-Needle Attachment
USP 881 – Tensile Strength
DURAMESH™ does not meet USP 861 – Sutures-Diameter
|Duramesh Size||Inner Diameter (mm)||Average Outer Diameter (mm)||Average Width when Flattened (mm)||Average Depth when Flattened (mm)|
SIZE AND NEEDLE CHOICE
Selection of a particular size of DURAMESH™ and specific needle choice will depend on the quality of the tissues and the surgical procedure. The surgeon should rely on his or her training, education, and experience for size selection. The surgeon should be guided by the USP designation, namely that a 2-0 DURAMESH should be selected as a substitute for a 2-0 standard suture, and similarly for the 0, Number 1 and Number 2 DURAMESH™ sizes.
INSTRUCTIONS FOR OPENING
When preparing to use DURAMESH™, remove the Tyvek pouch from the protective outer box.
DO NOT PLACE Tyvek pouch on the sterile tray, as the outside of the Tyvek pouch is NOT STERILE.
To open, peel open the Tyvek pouch. Take care to expose but not contaminate the inner sterile card and protective tube.
After the Tyvek pouch is opened, use sterile gloves to grasp the inner card holding DURAMESH™, and place on the sterile tray.
When the surgeon is ready to use DURAMESH™, open the needle flap to reveal the needle and the foam protector housing the sharp needle tip.
With a sterile needle driver, grasp the needle at approximately one-third to one-half the distance from the swaged end to the needle tip.
With the needle driver grasping the needle, gently and carefully pull DURAMESH™ out of its protective tube in a slow but deliberate motion.
USE CAUTION when pulling DURAMESH™ out of its protective tube so that it does not come into contact with items outside the sterile field as each DURAMESH™ is approximately 36 inches in length.
INSTRUCTIONS FOR PROPER USE
DURAMESH™ should remain housed within its protective tube until the surgeon is ready to use it.
When the surgeon is ready, grasp the needle with the needle driver and pull the DURAMESH™ slowly and deliberately out of its protective tube.
BE CAREFUL of DURAMESH springing out of the protective tube, as it could encounter items outside the sterile field.
Each DURAMESH™ should be visually inspected and examined prior to implantation and continuously monitored throughout the surgical procedure to ensure that both its structural integrity and sterility have not been compromised in any way.
AVOID CRUSHING OR CRIMPING THE DURAMESH™ BODY when handling it with forceps, clamps, or needle drivers. Crushing or crimping the DURAMESH™ body may adversely affect the tensile strength of the device.
DURAMESH™ may kink when removed from its package or during normal use. Kinking is acceptable and does not affect performance.
In contrast, a DURAMESH™ which appears crushed, crimped, damaged or compromised in any other way should NOT be implanted.
DURAMESH™ is designed to self-orient and flatten naturally when implanted.
DO NOT TWIST DURAMESH™ during implantation as that may affect performance.
DO NOT EXCESSIVELY TENSION DURAMESH™ during implantation as that may affect performance.
DO NOT PASS DURAMESH™ THROUGH ITSELF, either to create a knot or for any other purpose, as this could damage the integrity of the product.
DURAMESH™ should be passed through tissues SLOWLY & DELIBERATELY to minimize possible damage to the tissues. Passage through tissues is easiest if slight tension is maintained on both the leading and trailing ends.
KNOT security requires the accepted surgical technique of at least one flat square tie, with one additional throw for security. Knot testing with DURAMESH demonstrates that even a single well-done square knot will resist untying. Additional throws are acceptable as warranted by surgical circumstance and surgeon training. If the surgeon fails to alternate direction of the knots, at least 5 slip throws are required to prevent knot failure and are not recommended. Failure to adequately secure DURAMESH™ Suturable Mesh 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. Knot tying should be slow and deliberate to maintain the individual filaments’ integrity and avoid separation. DURAMESH™ Suturable Mesh is cut with standard surgical scissors 2-3 mm from a surgical knot.
Surgeons are encouraged to space DURAMESH™ in terms of the amount of surgical "bite" and the spacing between bites as per their years of training, education, experience, and evaluation of the tissues. For laparotomy closure, experimental data using a porcine abdominal wall suggests optimal placement of DURAMESH™ to be one-cm bites with one-cm travels. Draw the suture slowly and deliberately through the tissues to avoid local tissue trauma with passage of the device. To avoid damaging needle points and swage areas, grasp the needle in an area one-third (1/3) to one-half (1/2) of the distance from the needle swaged end to the needle tip. Reshaping needles may cause them to lose strength and be less resistant to bending and breaking. Users should exercise caution when handling surgical needles to avoid inadvertent needle sticks. Discard used needles in designated “sharps” containers.
DO NOT USE if the DURAMESH™ box is open, broken, perforated, torn, or damaged, as sterility may be compromised.
DO NOT USE if the Tyvek pouch or seal is open, broken, perforated, torn or damaged, as sterility may be compromised.
DO NOT USE after the expiration date noted on the label.
DO NOT USE elements of the packaging for the surgical procedure or for other purposes for which the packaging was not designed.
AFTER USE, DISCARD all unused product properly as potentially biologically hazardous and according to local institutional requirements.
DO NOT REUSE, REPROCESS, OR RE-STERILIZE THIS DEVICE. Each package of DURAMESH™ is intended for use in one patient, on a single occasion only. Do not reuse once the product has been removed from its packaging and/or is in contact with a patient. Reuse or reprocessing may cause contamination, device failure, patient infection or other surgical complications.
No long-term clinical studies have been conducted to evaluate the physiological impact of DURAMESH™. It is the responsibility of the surgeon to advise patients or their representatives, prior to implantation, of all warnings and precautions associated with the use of DURAMESH™ including possible associated surgical risks and potential outcomes. Patients should be instructed to immediately report any unusual overlying wound appearance or drainage, or any signs of infection at the surgery site that occur at any time after the implantation. Patients with compromised immune systems and/or pathology should be considered carefully as surgery candidates, as alternatives exist. Patients should provide their informed consent only after reviewing the risk-benefit analysis of the given procedure, along with options for alternate repairs. A thorough assessment of each patient should be made to determine the suitability for the use of DURAMESH™. The patient should be counseled as to alternative sutures and/or mesh use. Counseling should include but not be limited to a discussion that DURAMESH™ is a permanent prosthetic implant, and that some complications associated with prosthetic implants may require additional surgery. Counseling should include the possibility of debilitating chronic pain, and of repeat surgery including implant removal that may not resolve these complications. Serious adverse tissue responses or infection may require removal of the implant, either in part or in whole, and this may require dissection and/or multiple surgical procedures. Informed patient consent should be obtained prior to surgery regarding possible surgical complications and outcomes.
DURAMESH™ Suturable Mesh is a permanent implant and should only be used by surgeons familiar with the surgical procedures and techniques that require a permanent implant of this type. User should be familiar with surgical procedures and techniques involving non-absorbable sutures and non-absorbable meshes before using DURAMESH™. No long-term clinical outcome studies have been conducted with DURAMESH™. New products such as DURAMESH™ Suturable Mesh should not be assumed to have equal or improved safety and efficacy unless and until such long-term, peer-reviewed, and evidence-based clinical data is available. As such, DURAMESH™ Suturable Mesh should be reserved for high-risk individuals in whom the benefit of a permanent prosthetic implant may justify the risks as compared to existing mesh products, sutures, and other tissue approximation devices. Patients should provide their informed consent only after reviewing the risks and benefits of the procedure, as well as alternatives. Certain additional considerations should be used prior to implantation of DURAMESH™ Suturable Mesh and should be discussed with patients or their representatives:
Carefully weigh and consider the risk/benefit balance of DURAMESH™ use in patients with any significant co-morbidities including but not limited to, obesity (BMI >30), age over 30, history of smoking, diabetes, immunosuppression, malnourishment, poor tissue oxygenation (such as COPD), pre- or post- operative radiation, hypertension, drug abuse, lung disease, ascites, infection, cancer, renal disease, inflammatory bowel disease, liver disease, prior hernia, prior transplant, cardiovascular disease, prior wound complications, Elixhauser comorbidities: >1, hyperlipidemia, anemia, or recent weight loss.
DURAMESH™ should not be put in direct contact with bowel, viscera, or bladder.
For general soft tissue approximation and/or ligation, the risk of suture pull-through or dehiscence may vary with the site of application, the quality of tissues, the tension applied, and the size of suture material used.
Use Good Surgical Practice during the procedure.
DURAMESH™ may be used in both interrupted as well as running fashion. Tension and placement are application-dependent; however, caution and sound clinical judgment should be used so as not to over-tension DURAMESH™ when approximating tissues.
Careful use in areas where pressure can cause discomfort due to knot palpability, such as the plantar feet and the perineum, is advised.
Re-exploration through an area previously closed with DURAMESH™ will require the division of the implant. Removal of the implant at the time of re-exploration and subsequent surgery will require the excision of local tissue that has grown into and incorporated the implant.
Applicable surgical practices must be followed with respect to closure of infected or contaminated wounds. Placement of DURAMESH™ in a contaminated surgical field can be performed, but doing so is based on the surgeon's judgment, training, and experience. There is an increased risk that the implant will need to be removed in these situations.
Placement of DURAMESH™ in a contaminated field may potentiate an existing infection. Whenever clinical circumstances require implantation in a site that is contaminated or infected, appropriate local and/or systemic anti-infective measures should be taken.
Poor general medical condition or any pathology that would limit the blood supply and compromise healing should be considered when selecting patients for implantation of DURAMESH™ as such conditions may compromise a successful clinical outcome.
Prior to DURAMESH™ implantation, the use of pre-habilitation protocols should be considered, when appropriate.
Prior to DURAMESH™ implantation, standard bioburden-reducing techniques are recommended to minimize contamination levels at the surgical site including, but not limited to, appropriate drainage and debridement of contaminated soft tissue, negative pressure therapy, and/or appropriate pre- and post-operative antimicrobial therapy.
Prior to DURAMESH™ implantation, ensure that the patient understands the postoperative risks and complications of mesh surgery as well as limited long-term outcomes data.
These precautions and instructions are designed to serve as a general guideline only. They are not intended to supersede institutional protocols or sound professional clinical judgement concerning patient care.
POST-OPERATIVE CARE RECOMMENDATIONS:
Proper post-operative care may include the use of appropriate drainage and negative pressure therapy. Aseptic technique should be practiced to minimize contamination of the surgical wound. If an infection develops, treat the infection promptly and swiftly. If the infection remains unresolved, device removal may be required. If infection or any other post-surgical complications occur, consideration should be given for implant removal.
PATIENT RECORD LABEL
Patient record labels identifying the type, size, and lot number of the implant are included inside each DURAMESH™ package. This patient record label should be affixed to, or its information otherwise noted, in the patient’s permanent medical record to identify each implanted device.
POTENTIAL ADVERSE EVENTS
Potential adverse events are those associated with surgery using implantable synthetic mesh materials. As with all foreign bodies and permanent prosthetic implants, there is a potential for chronic infection. Local irritation at the surgery site and/or foreign body response with scarring or pain may occur. Complete failure of the surgical procedure is also a risk. Informed patient consent should be obtained prior to surgery regarding possible surgical complications and outcomes, including, but not necessarily limited to, the following potentially severe complications that are known to arise in connection with synthetic mesh implantation: swelling, bruising, inflammation, wound or surgical site infection, erosion, migration, bowel or other adhesions, bowel obstruction, hernia formation or recurrence, exposure, tearing, perforation, erosion, pain both acute and chronic, viscus perforation, scarring, allergic and/or foreign body reaction, abscess formation, bleeding, chronic inflammation and/or discharge, allergic or other immune response, tissue sloughing or necrosis, failure of the implant, delayed wound healing, organ damage, nerve damage, blood vessel damage, fistula formation, hematoma, seroma, limitation of joint motion, need for blood transfusion, palpability of knots, painful knots, scarring and/or tissue contracture, and wound dehiscence.
TO REPORT ADVERSE EVENTS:
In the U.S. Adverse events potentially attributed to DURAMESH™ must be reported promptly to your local DURAMESH™ representative. Alternatively, please call Mesh Suture Inc. at 1-844-347-2600.
Outside the U.S. Adverse events potentially attributed to DURAMESH™ use must be reported to your local DURAMESH™ Marketing Authorization Holder. Contact details for Marketing Authorization Holder can be found at meshsuture.com/complaints.
TO REPORT PRODUCT COMPLAINTS
Mesh Suture requests that physicians notify the company of any problems, complaints, or adverse events which may occur in connection with the use of DURAMESH™. Please use the contact information above.
FOCUSED ON PATIENT SAFETY
Mesh Suture is focused on product and patient safety and conducts comprehensive safety monitoring and evaluations throughout all stages of our product lifecycle. We are also committed to the safe and efficacious use of our products. If you experience any unanticipated side effects or have a complaint about DURAMESH™, please contact us immediately.
PRODUCT ORDERING INFORMATION
Can be obtained through the company website meshsuture.com.
Literature references are available through the company website meshsuture.com
SURGEON TRAINING AND EDUCATION
Training videos can be obtained or requested through the company website meshsuture.com.
SYMBOLS USED FOR LABELING
PATENT AND TRADEMARK NOTICES
For patent information visit meshsuture.com/patents. The absence of a product name from this list or U.S. Patent number as associated with any listed product does not constitute a waiver of Mesh Suture Inc.’s patent, trademark, or other intellectual property rights concerning their products. Additional patents may be pending or issued in the U.S. and elsewhere. DURAMESH™ is a registered trademark of Mesh Suture Inc. © Mesh Suture Inc. 2019. All Rights Reserved.
Manufactured for Mesh Suture Inc. by:
Surgical Specialties Mexico, S. DE R.L. DE C.V.
Corredor Tijuana – Rosarito 2000, #24702-B
Ejido Francisco Villa, Tijuana
B.C., C.P. 22235 Mexico
2514 AP The Hague