1. ARTISYN^® Instructions for Use. Somerville, NJ: Ethicon, Inc. 2015

2. Amarasinghe C. Surgeon design validation completion report. ARTISYN^® Y-Shaped Mesh. DVCR0000031 version A. June 20, 2012

3. Cobb WS, Burns JM, Peindl RD, et al. Textile Analysis of Heavy Weight, Mid-Weight and Light Weight Polypropylene Mesh in a Porcine Ventral Hernia Model. J Surg Res. 2006;136(1):1-7

ARTISYN™ Y-Shaped Mesh
ESSENTIAL PRODUCT INFORMATION

INDICATIONS
ARTISYN™ Y-Shaped Mesh is indicated for use as a bridging material for sacrocolposuspension/sacrocolpopexy (laparotomy or laparoscopic approach) where surgical treatment for vaginal vault prolapse is warranted.

CONTRAINDICATIONS
•    ARTISYN™ Y-Shaped Mesh should not be used in infants, children, pregnant women, or in women planning future pregnancies, because the mesh will not stretch significantly as the patient grows.
•    ARTISYN™ Y-Shaped Mesh should not be used in the presence of active or latent infections or cancers of the vagina, cervix, or uterus.
•    ARTISYN™ Y-Shaped Mesh must always be separated from the abdominal cavity by peritoneum. 
•    ARTISYN™ Y-Shaped Mesh must not be used following planned intraoperative or accidental opening of the gastrointestinal tract. Use in these cases may result in contamination of the mesh, which could lead to infection that may require removal of the mesh.

WARNINGS
•    Patients who are on anticoagulation agents and undergoing surgery using ARTISYN™ Y-Shaped Mesh must have their anticoagulation therapy carefully managed.
•    A digital rectal examination may be performed to detect possible rectal perforation.
•    Cystoscopy may be performed to confirm bladder integrity or to detect possible bladder or ureteral perforation.
•    Postoperatively, the patient should be advised to refrain from intercourse, heavy lifting, and/or exercise (e.g., cycling, jogging) until the physician determines when it is suitable for the patient to return to her normal activities.
•    Use ARTISYN™ Y-Shaped Mesh with care, and with attention to patient anatomy and to proper dissection technique, to avoid damage to vessels, nerves, bladder, bowel, and vaginal wall.
•    The safety and effectiveness of this product has not been validated in
clinical trials.
•    Reuse of this device (or portions of this device) may create a risk of product
degradation and cross-contamination, which may lead to infection or
transmission of bloodborne pathogens to patients and users. 

PRECAUTIONS
•    Users should be familiar with surgical procedures and techniques involving pelvic floor repair and synthetic meshes before employing ARTISYN™ Y-Shaped Mesh.
•    Avoid placing excessive tension on the mesh implant during placement.
•    This product should only be used under the prescription of a licensed healthcare practitioner.
•    In patients with compromised immune systems or other conditions that could compromise healing, the risks and benefits should be weighed carefully.
•    Vaginal or urinary tract infection should be treated and alleviated prior to implantation.
•    Acceptable surgical practice should be followed for ARTISYN™ Y-Shaped Mesh as well as for the management of infected or contaminated wounds. If ARTISYN™ Y-Shaped Mesh is used in contaminated areas, it must only be with the understanding that subsequent infection may require its removal.
•    Prolapse repair may unmask pre-existing incontinence conditions.
•    Prophylactic antibiotics can be administered according to the surgeon’s usual practice.
•    The use of this product with tissue adhesives is not recommended, as data are not currently available.

ADVERSE REACTIONS
•    Potential adverse reactions are those typically associated with surgery employing implantable materials of this type, bleeding including hemorrhage or hematoma, urinary incontinence, urge incontinence, urinary frequency, urinary retention or obstruction, voiding dysfunction, acute  and/or chronic pain, wound dehiscence, nerve damage, recurrent prolapse, inflammation, adhesion formation, fistula formation, contracture, scarring and mesh extrusion, exposure, or erosion into the vagina or other structures or organs.
•    As with any implant, a foreign body response may occur.  This response could result in extrusion, erosion, exposure, fistula formation and/or inflammation. 
•    Potential adverse reactions are those typically associated with pelvic organ prolapse repair procedures, including pelvic pain or pain with intercourse, which in some patients may not resolve
•    Dissection for pelvic floor repair procedures has the potential to impair normal voiding for a variable length of time.
•    Excessive contraction or shrinkage of the tissue surrounding the mesh, vaginal scarring, tightening and/or shortening may occur.
•    As with all surgical procedures, there is a risk of infection.  As with all foreign bodies, ARTISYN™ Y-Shaped Mesh may potentiate existing infection.
•    Punctures or lacerations of vessels, nerves, structures, or organs, including the bladder, urethra or bowel, may occur and may require surgical repair.
•    Neuromuscular problems, including acute and/or chronic pain in the groin, thigh, leg, pelvic and/or abdominal area may occur
•    These adverse reactions may require surgical treatment.
•     As with any surgery, one or more revision surgeries may be necessary to treat these complications.
•    ARTISYN™ Y-Shaped Mesh is a permanent implant that integrates into the tissue. In cases in which the ARTISYN™ Y-Shaped Mesh needs to be removed in part or whole, significant dissection may be required.

OTHER ADVERSE REACTIONS
•    Seroma
•    Adhesion formation
•    Atypical vaginal discharge
•    Exposed mesh may cause pain or discomfort to the patient’s partner during intercourse
•    Death

Consult your doctor to discuss the potential benefits and risks of your treatment options and whether ARTISYN™ Y-Shaped Mesh is appropriate for you.

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