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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: "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 pelvic floor reconstruction and the implantation of nonabsorbable meshes and biologic materials.The physician is advised to consult the medical literature regarding techniques, complications, and hazards associated with the intended procedures.Description: the avaulta plus¿ biosynthetic support system utilizes a nonabsorbable monofilament, polypropylene mesh to provide long-term reinforcement for support structures.Additionally, the avaulta plus¿ biosynthetic support system features a porous, acellular, ultra-thin sheet of crosslinked collagen attached to the polypropylene mesh which serves to establish a protective barrier between mucosal tissue and the polypropylene mesh and contains apertures uniformly sized to allow the ingrowth of host tissue and capillary vessels.The monofilament, polypropylene mesh used in the avaulta plus¿ biosynthetic support system has a soft knit in the central section for compliant organ support and host tissue ingrowth, and a strong knit in the lateral sides to provide improved strength for tension-free fixation of the mesh.The open knit design offers multidirectional strength and elasticity that allows the synthetic mesh to be trimmed at the physician¿s discretion without unraveling and to adapt to various body stresses.The pre-attached collagen sheet on the avaulta plus¿ biosynthetic support system covers the soft-knit central section of the mesh to provide both a thin collagen plane for ingrowth of native tissue as well as a protective mucosal tissue barrier.The lateral segments of the avaulta plus¿ biosynthetic support system are not covered to maximize mesh fixation immediately post-implantation.As a convenience to the physician, the avaulta plus¿ biosynthetic support system consists of a pre-cut graft for vaginal wall prolapse repair and an introducer needle to help facilitate placement of the graft.The graft may be further trimmed by the physician to achieve the desired geometry for the procedure.The instrumentation included in the avaulta plus¿ biosynthetic support system features a unique, patent-pending flexible snare system designed to minimize tissue trauma during implantation and allow for easier tip exteriorization and mesh arm capture.Indications: avaulta plus¿ biosynthetic support system is indicated for tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor in vaginal wall prolapse where surgical treatment is intended either as mechanical support or bridging material for the fascial defect.Contraindications: avaulta plus¿ biosynthetic support system is contraindicated for patients who are pregnant or may become pregnant, have a urinary tract infection, have an infection in the operative field, or patients in a period of growth because the mesh may not stretch significantly.Avaulta plus¿ biosynthetic support system with acellular dermal tissue has material derived from a porcine source and should not be used in patients with known sensitivity to porcine material.Warnings: - the implant procedure and the instrumentation associated with the surgical placement of the avaulta plus¿ biosynthetic 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 avaulta plus¿ biosynthetic 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: - 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 infected or contaminated wounds.- postoperative bleeding may occur in some patients and must be controlled prior to patient release.- the avaulta plus¿ biosynthetic support system implantation procedures require diligent attention to anatomical structures and care to avoid puncture of large vessels, nerves, bladder, bowel, urethra, rectum, or any viscera during introducer passage.- the avaulta plus¿ biosynthetic support system is provided in a sterile blister tray within a sterile pouch.The sterile blister tray may be placed in the sterile field.- the introducers provided with the anterior and posterior support systems are provided in a sterile blister tray.Transfer the introducer to the sterile field using aseptic techniques.Do not place the tray in the sterile field.- check the integrity of the packaging before use.Do not use the mesh or introducers if the packaging is opened or damaged.- as for any implantable material, it is recommended to open the blister tray at the time of implantation.- the avaulta plus¿ biosynthetic support system is intended as a single-use device.Do not re-sterilize any portion of the avaulta plus¿ biosynthetic support system.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 reactions: complications associated with the proper implantation of the avaulta plus¿ biosynthetic support system 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, rejection of biologic materials, pain, dyspareunia, scarification, contraction, device migration and failure of the procedure resulting in recurrence of vaginal wall prolapse.- urinary incontinence (stress and urge).Implant procedures: preparation of avaulta plus¿ biosynthetic mesh for implantation: at the time of implantation, avaulta plus¿ biosynthetic support system mesh must be hydrated.To hydrate, place the avaulta plus¿ biosynthetic support system mesh into the blister tray or other sterile dish and completely immerse in a sterile physiological solution for at least 3 minutes.Avaulta plus¿ biosynthetic support system mesh is more easily trimmed prior to hydration, but may be trimmed after hydration if desired, to approximate the total vaginal length over which the graft will provide support.If necessary, the proximal portion of the graft (apical extension) may be removed.Caution: the mesh should not be trimmed to a width less than 1 cm in order to maintain sufficient strength and prevent unraveling.Implantation technique for the avaulta plus¿ biosynthetic anterior support system: ¿ note: when using the avaulta plus¿ biosynthetic support system, the tissue layer of the graft may be oriented to face the vaginal mucosal tissue or the visceral side at the discretion of the physician.To help facilitate the desired orientation, the colored markers on the arms should be positioned on the patient¿s right side for the tissue layer to be positioned on the vaginal mucosal side.Conversely, the arm markers should be oriented on the patient¿s left side for the tissue layer to face the visceral side.¿ proximal end with apical flap positioned at vaginal apex.¿ proximal arms (long arms with pointed ends) passed through inferior medial aspect of obturator membrane.¿ distal end positioned at bladder neck.¿ distal arms (short arms with rounded ends) passed through superior medial aspect of obturator membrane.1.Place the patient in stirrups in the lithotomy position and prepare for surgery using standard operative procedures.2.Make an incision in the anterior vaginal wall through the vaginal mucosa and into the fascial plane between the mucosa and the bladder.Dissect the vaginal mucosa away from the bladder laterally to the obturator internus at the level of the bladder neck and proximally to the ischial spine on both sides.Ensure a thick dissection is created, leaving as much endopelvic fascia on the mucosa as possible.3.Identify the obturator fossa by grasping the adductor longus at its insertion to the pubic tubercle.Using the thumb to palpate under the adductor longus insertion, the superior medial aspect of the obturator fossa is identified.Palpate and draw the medial border of the obturator fossa to its inferior medial border.Make a vertical incision >1 cm approximately 1 cm below the superior medial border of the obturator fossa and lateral to the bladder neck for the distal arm of the mesh.Make a second vertical incision >1 cm at the inferior medial border of the obturator fossa and approximately lateral to the vaginal cuff.Repeat on the contralateral side.4.Locate the introducer needle and ensure that the snare is fully retracted into the needle tip prior to inserting the needle.Insert the tip of the introducer needle into the inferior medial groin incision to puncture through the obturator membrane.Orient the introducer in a horizontal plane, and direct the needle tip towards the ischial spine or top of the vaginal cuff.Identify the tip of the introducer before puncturing through the obturator internus muscle.With a gentle rotation of the introducer push through the obturator muscle and use the vaginal finger to guide the needle tip through the fascial wall to exit proximally at the vaginal apex, exposing at least 1-2 cm of the needle tip.Insert a right-angle retractor into the vagina along the anterior wall and extend the introducer snare using the thumb slider on the introducer handle.The introducer tip should be stabilized with two fingers during initial deployment of the snare.If necessary, guide the end of the snare to the introitus with a finger.Extend the thumb slider until the snare loop has fully exteriorized itself.5.Pass the proximal arm (pointed end) of the mesh up to the fold (about 5 cm) through the eyelet in the snare.Retract the snare using the thumb slider until it reaches the stop position.Take care to prevent the surrounding tissue from getting caught in the snare during retraction.Retract the introducer needle to draw the mesh arm out through the inferior groin incision.Ensure the mesh arm is not twisted during or after placement.Repeat steps 4 and 5 on the contralateral side.Note: if substantial resistance is felt during retraction of the introducer needle, ensure that no tissue has been caught in the needle during the snare retraction.Should this occur, re-extend the snare using the thumb slider mechanism, remove the trapped tissue, and re-retract the snare.6.Apply traction to draw the proximal (inferior) arms of the graft into the desired position such that the proximal end of the central graft is positioned at the vaginal apex.Be sure the graft is tension-free.7.Locate the introducer needle and ensure that the snare is fully retracted into the needle tip prior to inserting the needle.Insert the tip of the introducer needle into the superior groin incision and gently puncture through the obturator membrane.Orient the introducer in a horizontal plane, and direct the needle towards the level of the bladder neck.Use a vaginal finger to guide the needle tip through the obturator internus as before, exposing at least 1-2 cm of the needle tip.Extend the introducer snare using the thumb slider on the introducer handle until the snare loop has fully exteriorized itself at the vaginal introitus.8.Pass a distal arm (rounded end) of the mesh up to the fold (about 4 cm) through the eyelet in the needle tip.Retract the snare using the thumb slider until it reaches the stop position.Retract the introducer needle to draw the mesh arm out through the superior groin incision.Ensure the mesh arm is not twisted during or after placement.Repeat steps 7 and 8 on the contralateral side.9.Apply traction to draw the distal (superior) arms of the graft into the desired position such that the distal end of the central graft is positioned near the bladder neck.If significant folds are observed, scissors may be used to cut a small section out of the midline of the graft under the bladder neck.Apply additional traction to the distal (superior) arms to help take up the slack and flatten the mesh under the bladder.The colored midline marker may be used to facilitate desired placement of the graft.Ensure the central graft is positioned under the bladder without excessive tension.A cystoscopy should be performed to confirm integrity of the bladder after the mesh has been positioned.10.The mesh should be sufficiently anchored to stabilize it during tissue ingrowth.Additional sutures may be used to secure the mesh tension-free.Anchoring points should be positioned at least 1 cm from the edge of the mesh.Extra care should be used when positioning the avaulta plus¿ biosynthetic support system implant to prevent tearing of the accelular collagen sheet.After desired positioning is complete, at the physician¿s discretion, the entire graft and incision line may be irrigated with an appropriate antibiotic solution.Trimming of the vaginal mucosa should be limited to only mucosal edges damaged by instruments.Caution: excessive tension should be avoided on the mesh and suture attachment points to account for wound shrinkage during the healing process.11.Close the anterior vaginal wall incision using a running stitch.It is advised to use a monofilament suture for closure, though it is not advised to use an interrupted or locking stitch as this may cause excessive hemostasis, resulting in delayed closure.Trim all ends of the mesh arms below the level of the skin and close skin incisions.Implantation technique for the avaulta plus¿ posterior support system: ¿ note: when using the avaulta plus¿ biosynthetic support system, the tissue layer of the graft may be oriented to face the vaginal mucosal tissue or the visceral side at the discretion of the physician.To help facilitate the desired orientation, the colored markers on the arms should be positioned on the patient¿s right side for the tissue layer to be positioned on the vaginal mucosal side.Conversely, the arm markers should be oriented on the patient¿s left side for the tissue layer to face the visceral side.¿ proximal end with apical flap positioned at vaginal apex.¿ proximal arms (long arms with pointed ends) passed through ischiorectal fossa.¿ distal end positioned at perineal body.¿ distal arms (short arms with rounded ends) passed through ischiorectal fossa.1.Place the patient in stirrups in the lithotomy position and prepare for surgery using standard operative procedures.2.Make an incision in the posterior vaginal wall through the vaginal mucosa and into the fascial plane between the mucosa and the rectum.Use blunt and sharp dissection to dissect the vaginal mucosa away from the rectum laterally to the pelvic sidewalls and proximally to the ischial spine on both sides.Ensure a thick dissection is created, leaving as much endopelvic fascia on the mucosa as possible.3.Make two small pararectal incisions (>1 cm) approximately 3 cm lateral and 3 cm posterior to the anus.4.Locate the introducer needle and ensure that the snare is fully retracted into the needle tip prior to inserting the needle.Orient the introducer needle with the handle positioned vertically and the needle tip horizontal and parallel to the vaginal floor.Insert the needle tip into one of the pararectal incisions, aiming the needle tip towards the ischial spine.Pass the introducer through the ischiorectal fossa passing lateral to the posterior wall of the rectum until the needle tip nears the ischial spine, so that the proximal arms of the graft can be placed at or just cephalad to the level of the ischial spine.Move the handle downwards to direct the needle tip upwards approximately 1 cm proximal to the ischial spine and out through the posterior vaginal wall incision, exposing at least 1-2 cm of the needle tip.At the physician¿s discretion, the proximal arms may be secured through the sacrospinous ligament using a similar motion.Exercise care not to tear the pelvic tissue during passage.Insert a right-angle retractor into the vagina along the anterior wall and extend the introducer snare using the thumb slider on the introducer handle.The introducer tip should be stabilized with two fingers during initial deployment of the snare.If necessary, guide the end of the snare to the introitus with a finger.Extend the thumb slider until the snare loop has fully exteriorized itself.Note: it is recommended that a rectal probe be used to divert the rectum away during the needle passage.5.Pass the proximal mesh arm (pointed end) up to the fold (about 5 cm) through the eyelet in the snare.Retract the snare using the thumb slider until it reaches the stop position.Take care to prevent the surrounding tissue from getting caught in the snare during retraction.Retract the introducer needle to draw the mesh arm out through the pararectal skin incision.Ensure the mesh arm is not twisted during or after placement.Repeat steps 4 and 5 on the contralateral side.Note: if substantial resistance is felt during retraction of the introducer needle, ensure that no tissue has been caught in the needle during the snare retraction.Should this occur, re-extend the snare using the thumb slider mechanism, remove the trapped tissue, and re-retract the snare.6.Apply traction to draw the proximal arms of the graft into the desired position such that the proximal end of the central graft is positioned at the vaginal apex.Avoid placing excessive tension on the graft.7.Approximate the total vaginal length over which the graft will provide support.If necessary, use scissors to remove as much of the distal portion of the collagen sheet as is necessary so that the collagen terminates inside the vaginal introitus.Make a vertical cut along the blue center line of the polypropylene mesh to just inside the vaginal introitus to allow the graft to lie flat over the rectum once the distal arms are placed.8.Locate the introducer needle and ensure that the snare is fully retracted into the needle tip prior to inserting the needle.Insert the tip of the introducer needle into the same pararectal incision created in step 3 and orient the needle tip towards the vaginal introitus.Exercise care to stay lateral to the anal sphincter and rectum during passage.Use a vaginal finger to guide the needle tip through the posterior vaginal wall incision at the perineal body and at the most lateral portion of the dissection (the junction of the transverse perineal and bulbocavernosus muscles), exposing at least 1-2 cm of the needle tip.Extend the introducer snare using the thumb slider on the introducer handle until the snare loop has fully exteriorized itself at the vaginal introitus.9.Pass the distal mesh arm (rounded end) 3-4 cm through the eyelet in the needle tip.Retract the snare using the thumb slider until it reaches the stop position.Retract the introducer needle to draw the mesh arm out through the pararectal skin incision.Ensure the mesh arm is not twisted during or after placement.Repeat steps 8 and 9 on the contralateral side.10.Apply traction to draw the distal arms of the graft into the desired position such that the distal end of the central graft is positioned next to the perineal body.The colored midline marker may be used to facilitate desired placement of the graft.Ensure the central mesh lays over the rectum without excessive tension.A digital rectal exam should be performed to confirm integrity of the rectum after the mesh is positioned.11.The mesh should be sufficiently anchored to stabilize it during tissue ingrowth.Additional sutures may be used to secure the mesh tension-free.Anchoring points should be positioned at least 1 cm from the edge of the mesh.Extra care should be used when positioning the avaulta plus¿ biosynthetic support system implant to prevent tearing of the acellular collagen sheet.After desired positioning is complete, at the physician¿s discretion, the entire graft and incision line may be irrigated with an appropriate antibiotic solution.Trimming of the vaginal mucosa should be limited to only mucosal edges damaged by instruments.Caution: excessive tension should be avoided on the mesh and suture attachment points to account for wound shrinkage during the healing process.12.Close the posterior vaginal wall incision using a running stitch.It is advised to use a monofilament suture for closure, though it is not advised to use an interrupted or locking stitch as this may cause excessive hemostasis, resulting in delayed closure.Trim all ends of the mesh arms below the level of the skin and close skin incisions.Sterilization technique: avaulta plus¿ biosynthetic support system is a single-use device.The implant and introducers are sterilized by ethylene oxide.Do not resterilize.Storage: recommended storage conditions: between 2°- 40°c (36°-105°f) in a dry area.(b)(4).
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