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The device was not returned for evaluation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: ¿caution: federal (usa) law restricts this device to sale by or on the order of a physician.This product is intended for use only by physicians trained in the surgical procedures and techniques required for the treatment of female stress urinary incontinence and the implantation of nonabsorbable meshes.The physician is advised to consult the medical literature regarding techniques, complications, and hazards associated with the intended procedures.Description: the align® to trans-obturator urethral support system (align® to urethral support system) is a suburethral sling device intended for the treatment of female stress urinary incontinence.The system consists of stainless steel trans-obturator introducers and a polypropylene mesh sling implant encased in a protective sheath with green guide tubes at each end of the sheath.Connectors are attached to the distal ends of the guide tubes, and are designed to attach to the tip portion of the introducer needles.The device is terminally sterilized by ethylene oxide.Indications for use: the align® to urethral support system is indicated for the treatment of female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.Contraindications: the align® to urethral support system is contraindicated for patients experiencing any of the following conditions: pregnancy, urinary tract infection, anticoagulant therapy, and/or infection in the operative field.Warnings: the implant procedure and the instrumentation associated with the surgical placement of the align® to urethral support system carry an inherent risk of infection and bleeding, as do similar urological procedures.The use of surgical staples, clips, screws, or other non-suture attachment mechanisms not supplied with the align® to urethral support system can damage the implant.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: the usual precautions associated with urological procedures should be followed: based on physician experience and training, a thorough assessment of each patient should be made to determine their suitability for the implant procedure.Additional consideration should be given to use of the implant 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 contaminated or infected wound sites, when the align® to urethral support system is used.Postoperative bleeding may occur in some patients and must be controlled prior to patient release.The implant procedure requires diligent attention to anatomical structures and care to avoid puncture of large vessels, nerves, bladder, bowel, urethra and any viscera, during introducer passage.Due to anatomical distortion that can be caused by pelvic organ prolapse, if the patient requires cystocele repair, it should be performed prior to the implantation of the sub-urethral sling.Proper placement of the sling implant at the mid-urethra requires that it lie flat with minimal or no tension under the urethra.The align® to urethral support system is intended as a single-use device.Do not re-sterilize any portion of the align® to urethral support system.Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural 5 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.Patients should be advised that pregnancy following a sling implant procedure may negatively affect the success of the previous implant procedure and incontinence may recur.The safety and effectiveness of the align® to urethral support system implant procedure has not been established for the treatment of stress urinary incontinence in males and children under the age of 18.Cystoscopy can be considered at the physician¿s discretion.Check the integrity of the packaging before use.Do not use the align® to urethral support system if the packaging is opened or damaged.As for any implantable material, it is recommended to open the package at the time of implantation.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 align® to urethral support system may include, but are not limited to: postoperative hematoma, seroma, abscess or fistula formation, or scarring which may occur following the implant procedure.Urinary retention, bladder outlet obstruction and other voiding 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, 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 incontinence.Implant procedure: align® to urethral support system may be implanted using local, regional, or general anesthesia.Operative preparation: position the patient in a dorsal lithotomy position with hips in flexion and the buttocks even with the edge of table.Insert foley catheter and drain the bladder until empty.Place allis clamps on the vaginal mucosa overlying the urethra.One clamp is placed approximately 1cm from the external urethral meatus and the other at the urethrovesical junction.Inject solution (i.E., 1% lidocaine with epinephrine) into the vaginal mucosa and periurethral tissue if desired.Make a small vertical incision in the anterior vaginal wall beginning approximately 1cm under the urethral meatus.Gently free the urethra from the anterior vaginal wall.Dissect laterally in a 45° angle toward the ischiopubic ramus bone using scissors and checking the depth digitally.This procedure is repeated on the contralateral side.Prior to making the skin incisions, identify the obturator fossa by grasping the insertion of the adductor longus at its insertion to the pubic tubercle.By rocking a thumb under the adductor longus insertion, the superior medial portion of the obturator fossa is identified.The site for the skin incisions will be located just inferior to this location, and lateral to the bony edge.Make two small skin incisions laterally at the level of the clitoris in the fold of the thigh, facing the medial part of the obturator foramen.Introducer insertion and implant placement: insert the hook or halo introducer into one of the skin incisions perpendicular to the perineum to puncture the obturator membrane immediately adjacent to the ischiopubic ramus.When the obturator membrane has been perforated (noted by a distinctive pop), orient the handle at a 45° angle relative to the patient¿s sagittal plane.Keeping the introducer handle close to the patient, rotate the handle to pivot the introducer tip towards the urethra.Place the index finger of the opposite hand in the ipsilateral dissection pouch to ensure that the introducer does not perforate the vagina or go above the vaginal dissection.Guide the introducer behind the ischiopubic branch to meet the tip of the surgeon¿s index finger.If the introducer needle tip can not be located, gently retract the introducer needle and slowly advance until it can be located.Guide the introducer tip with the index finger towards the vaginal incision until the tip is exteriorized at the level of the vaginal incision.Ensure that contact is maintained between the surgeon¿s index finger and the introducer tip until the tip is exteriorized.Grasp the connector between the thumb and index finger as indicated by the arrows in the image below.Attach the connector to the introducer tip by pushing it straight onto the needle.Detectable feedback of the connection will alert the physician that the connector has been properly engaged.Gently apply traction on the handle to draw the guide tube back through the skin incision.The tube may be cut with scissors or the connector can be detached from the introducer or may be left attached if desired.Take care to ensure that the sheath assembly is not twisted and that the green tab is facing outward and is positioned suburethrally.Repeat steps 1-6 on the patient¿s contralateral side using the second introducer.The two ends of the green guide tube are used to draw the protective sheath through the obturator membranes into position, placing the green mid-point tab loosely under the mid-urethra.In order to remove the sheath, it is first necessary to grasp the two sides of the mid-point tab and peel them away from the center of the sheath as indicated by the arrows.The tab will then slide off of the two proximal ends of the sheath.Place a blunt instrument between the urethra and the mesh while adjusting and positioning the sling.When the appropriate tension is attained, remove the sheath to fully expose the mesh by pulling gently on both lateral ends of the sheath.Keep the blunt instrument in place under the urethra when removing the two ends of the sheath to ensure that over-tightening of the mesh does not occur.Cut the exposed mesh strips at the level of the subcutaneous tissue and close each skin incision.Close the vaginal incision.Note: the halo system comes with right-hand and left-hand introducers designed for each side of the patient.Note: if an introducer needle(s) need to be re-passed, follow the steps outlined below: measure roughly 1.0" behind the connector toward the sheath and make a cut across the green guide tube.A hollow opening should now be visible inside of the green guide tube.Locate the slit opposite the d-window on the side of the connector.While grasping the connector between the thumb and index finger as before, apply force perpendicular to needle shaft to free needle through the slit.Slide the connector mechanism off of the introducer needle tip.Follow the introducer insertion steps outlined above to re-pass the introducer needle.Once the needle has been re-passed, push the green guide tube onto the introducer tip.Ensure that tube has been inserted completely onto the introducer tip and is securely attached.Follow the implant placement steps outlined above to complete the procedure.Supply the align® to urethral support system is intended as a single-use, disposable device.Do not resterilize any portion of the align® to urethral support system.The device is terminally sterilized by ethylene oxide.The align® to urethral support system is supplied as a complete operative kit consisting of two stainless steel hook and/or halo trans-obturator introducers and a polypropylene mesh implant sling encased in a protective sheath with green guide tubes and connectors at each end.Storage store at ambient temperature.Do not use the device past the last day of the labeled month of expiration.Upon receipt of shipment, ensure that the packaging is not open or damaged and retains its sealed integrity.Do not use the device if the integrity of the packaging appears compromised." (b)(4).
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