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The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use states the following: "alyte y-mesh graft instructions for use caution: federal (usa) law restricts this device to sale by or on the order of a physician.The alyte® y-mesh graft is intended for use only by physicians who are trained in the surgical procedures and techniques required for pelvic floor reconstruction (including abdominal sacrocolposuspension / sacrocolpopexy) and the implantation of non-absorbable meshes.The physician is advised to consult the medical literature regarding techniques, complications, and hazards associated with the intended procedures.Description the alyte® y-mesh graft utilizes a variable knit lightweight/ultra-lightweight non-absorbable monofilament polypropylene mesh.The y-mesh configuration is designed such that the surgeon will be able to alter/trim the graft to different sizes as required to fit each patient¿s anatomical requirements without unraveling.Indications for use the alyte® y-mesh graft 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 the use of the alyte® y-mesh graft is contraindicated for patients who are pregnant or may become pregnant, or those with a systemic infection or infection in the operative field.Warnings ¿ the effectiveness of this product has not been validated by a prospective randomized clinical trial.¿ the implant procedure carries an inherent risk of infection and bleeding, as do similar urological procedures.¿ after use, the product and its packaging should be treated as a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable local, state, and federal laws and regulations.Precautions ¿ based on physician experience and training, a thorough assessment of each patient should be made to determine their suitability for a synthetic mesh procedure.Additional consideration should be given to the use of alyte® y-mesh graft in patients with a compromised immune system, any condition that would compromise healing, or any patient with a history of prior abdominal or pelvic surgeries.Consideration should also be given to the ability of the patient to tolerate the surgical procedure.¿ accepted surgical practice and precautions must be followed for the management of infected or contaminated wounds.¿ postoperative bleeding may occur in some patients and must be controlled prior to patient release.¿ sutures should not be placed in the mesh edge.Sutures should be placed a minimum of 1cm from any mesh edge.¿ inadequate suturing of the graft material to the pelvic tissues may lead to failure of the repair, additional complications and recurrence of prolapse.¿ check the integrity of the packaging before use.Do not use the mesh if the packaging is opened or damaged.¿ as for any implantable material, it is recommended to open the package at the time of implantation.¿ the alyte® y-mesh graft is intended as a single-use device.Do not re-sterilize any portion of the alyte® y-mesh graft.Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient.¿ post-operatively the patient should be advised to refrain from heavy lifting, exercise (e.G.Cycling, jogging) and/or intercourse until the physician determines it is suitable for the patient to return to normal activities.Adverse events complications associated with the proper implantation of the alyte® y-mesh graft may include, but are not limited to those typically associated with surgically implantable materials including: ¿ postoperative hematoma, seroma, abscess or fistula formation, or scarring which may occur following the implant procedure.¿ urinary retention, bladder outlet obstruction and other voiding and defecatory dysfunctions.These conditions may be associated with over-correction/too much tension placed on the implant.¿ perforations or lacerations of vessels, nerves, bladder, bowel, urethra, rectum, or any viscera, which may occur during the implantation procedure.¿ irritation at the operative wound site which may elicit a foreign body response that leads to wound dehiscence, inflammation and/or infection.¿ extrusion through vaginal epithelium or erosion into surrounding viscera and/or mucosa.¿ inflammation, sensitization, pain, dyspareunia, scarification, contraction, device migration and failure of the procedure resulting in recurrence of vaginal wall prolapse.¿ urinary incontinence (stress and urge).Mesh characteristics a/p flaps sacral flap test method pore size (mm) 2.78 x 1.33 1.96 x 1.06 width and height of the pore was measured using an optical measuring system pore area (mm2) 2.34 1.28 measured using a optical measuring system mesh density (g/m2) 17.67 (ultra-light weight)* 35.55 (light weight)* weight (g) divided by area (m2) of a 4 x 9 cm section of mesh mesh thickness (mm) 0.29 0.40 measured using a thickness gage tensile strength (lbs) 5.9 12.1 measured using a tensile test system on a 12 mm x 100 mm mesh strip pulled at 4 inches per minute device stiffness ¿ machine direction (mg) 7.2 17.2 astm d 6125-97 device stiffness ¿ cross direction (mg) 3.4 6.2 astm d 6125-97 suture pull-out ¿ machine direction (lbs) 3.0 4.7 a 2-0 surgical suture is placed through the mesh 6 ¿ 8 mm from the edge and the ends tied off.The suture loop is pulled through the mesh until the suture or the mesh breaks.Suture pull-out ¿ cross direction (lbs) 2.8 4.5 a 2-0 surgical suture is placed through the mesh 6 ¿ 8 mm from the edge and the ends tied off.The suture loop is pulled through the mesh until the suture or the mesh breaks.Mesh ball burst testing (lbs) 17.1 35.4 measured using a modified version of astm d 3787-07.The steel ball was 3/8 inch in diameter instead of 1 inch as specified in the astm to facilitate testing of smaller samples.Note: variability between test methods and/or equipment between different manufacturers may result in values that are not readily comparable.*note: reference: earle, db and mark, la.Prosthetic material in inguinal hernia repair: how do i choose? surg clin n.Am 88 (2008): 179-201.Procedure: use of y shaped configuration for sacrocolposuspension / sacrocolpopexy procedures note: standard operative technique for a sacrocolposuspension / sacrocolpopexy procedure should be followed when using the alyte® y-mesh graft.1.Using your preferred procedural methodology (laparotomy or laparoscopic approach), prepare the patient anatomy for attachment of the alyte® y-mesh graft to the anterior and posterior vaginal walls, and the anterior longitudinal ligament overlying the sacral promontory.2.Determine the length of anterior wall that is to be covered by a vaginal flap of the alyte® y-mesh graft.Trim one vaginal flap to this length and designate this as the ¿anterior¿ flap.3.Determine the length of the posterior wall that is to be covered by the other vaginal flap of the alyte® y-mesh graft.Trim the remaining vaginal flap to this length and designate this as the ¿posterior¿ flap.4.If necessary, the width of the vaginal flaps can be further tailored to patient anatomy with the aid of the blue lateral markings.These markings are visual guides that may be used when trimming to facilitate mesh symmetry.5.Introduce the graft into the pelvic cavity, ensuring that the ¿anterior¿ and ¿posterior¿ flaps are oriented to the corresponding anatomy.Position the graft such that the apex of the vaginal flaps is aligned with the apex of the vagina.The blue midline marker may be used as a visual aid in lengthwise orientation of the mesh to the vagina.Note: the order of attachment ie.Anterior before posterior/posterior before anterior, is at the discretion of the implanting physician.6.Using a recommended minimum of 4 permanent sutures, attach the ¿anterior¿ flap of the alyte® y-mesh graft to the anterior wall of the vagina.Ensure that sutures are placed a minimum of 1cm from any mesh edge.7.Using a recommended minimum of 4 permanent sutures, attach the ¿posterior¿ flap of the alyte® y-mesh graft to the posterior wall of the vagina.Ensure that sutures are placed a minimum of 1cm from any mesh edge.8.Ensuring appropriate tension, attach the sacral section of the alyte® y-mesh graft to the anterior longitudinal ligament at the level of the sacral promontory using 2 permanent fixation points.9.Trim any excess sacral mesh proximal to the sacral attachment points.10.Reperitonealization of the graft is recommended.Sterilization technique alyte® y-mesh graft is a single-use device.The implant is sterilized by ethylene oxide.Do not resterilize.Copyright © 2011 c.R.Bard, inc.All rights reserved." patient codes: (b)(4).
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