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Sling for Incontinence

The mesh implant in our various Sling Systems is intended for use as a mid-urethral sling for the treatment of stress urinary incontinence.
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Prescriptive Information

Prescriptive Information

Indications

The mesh implant is intended for use as a suburethral sling for the treatment of stress urinary incontinence resulting from hypermobility and/or intrinsic sphincter deficiency.

Contraindications

The mesh suburethral sling implant is contraindicated in the following patients:

  • Pregnant patients, patients with potential for future growth or patients that are considering future pregnancies.
  • Any patients with soft tissue pathology into which the implant is to be placed.
  • Patients with any pathology which would compromise implant placement.
  • Patients with any pathology, such as blood supply limitations or infections that would compromise healing.

Warnings

Contents supplied STERILE using ethylene oxide (EO) process. Do not use if sterile barrier is damaged. If damage is found call your Boston Scientific representative.

For single patient use only. Do not re-use, re-process or re-sterilize. Re-use, re-processing or re-sterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death. Re-use, re-processing or re-sterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient.

After use, dispose of product and packaging in accordance with hospital, administrative and/or local government policy.

Potential Adverse Effects

The complications that have been reported due to suburethral sling placement include, but are not limited to:

  • As with all implants, local irritation at the wound site and/or a foreign body response may occur.
  • Tissue responses to the implant could include vaginal extrusion, erosion through the urethra or other surrounding tissue, migration of the device from the desired location, fistula formation and inflammation. The occurrence of these responses may require removal of the entire mesh.
  • Like all foreign bodies, the mesh may potentiate an existing infection.
  • Excess tension may cause temporary or permanent lower urinary tract obstruction and retention.
  • Known risks of surgical procedures for the treatment of incontinence include pain, infection, erosion, device migration, complete failure of the procedure resulting in incontinence and mild to moderate incontinence due to incomplete support or overactive bladder.
  • In addition to the above listed potential complications, allergic reaction, fistula, abscess, detrusor instability, pelvic and vaginal pain, dysparenia, vaginal bleeding, vaginal discharge, dehiscence of vaginal incision, edema and erythema at the wound site have been reported due to suburethral sling procedures.

Cautions

  • The procedure should be performed with very careful attention to avoid laceration of any vessels, nerves, bladder and bowel.
  • Retropubic bleeding can occur. Check carefully before releasing patient from the hospital.
  • Cystoscopy must be performed to confirm bladder integrity.
  • Do not remove the protective plastic sleeve covering mesh implant until proper position has been confirmed.
  • Use of this device should be done with the understanding that subsequent infection may require removal of the mesh.
  • Patients should be counseled to refrain from heavy lifting, exercise and intercourse for a minimum of 4 weeks. Physician should determine when it is suitable for each patient to return to normal activities.
  • Should dysuria, bleeding or other problems occur, the patient should be instructed to contact the physician immediately.
  • Do not use any mechanical means of contact with the mesh (such as clips, staples, etc.) within the urethral support region of the mesh, as mechanical damage to the mesh may occur.
  • Avoid excessive tension on the mesh during handling.

Prescriptive Information

Indications

The mesh implant is intended for use as a suburethral sling for the treatment of stress urinary incontinence resulting from hypermobility and/or intrinsic sphincter deficiency.

Contraindications

The Mesh Assembly is contraindicated in the following patients:

  • Pregnant patients, patients with potential for future growth or patients that are considering future pregnancies.
  • Any patient with soft tissue pathology into which the implant is to be placed.
  • Patients with any pathology which would compromise implant placement.
  • Patients with any pathology such as blood supply limitation or infection that would compromise healing.

    • Warnings

    Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if sterile barrier is damaged. If damage is found call your Boston Scientific representative. For single patient use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient. After use, dispose of product and packaging in accordance with hospital, administrative and/or local government policy.

    Potential Adverse Effects

    The following complications that have been reported due to suburethral sling placement includes, but are not limited to:

  • As with all implants, local irritation at the wound site and/or a foreign body response may occur.
  • Tissue responses to the implant could include vaginal extrusion, erosion through the urethra or other surrounding tissue, migration of the device from the desired location, fistula formation and inflammation. The occurrence of these responses may require removal of the entire mesh.
  • Like all foreign bodies, the mesh may potentiate an existing infection.
  • Excess tension may cause temporary or permanent lower urinary tract obstruction and retention.
  • Known risks of surgical procedures for the treatment of incontinence include pain, infection, erosion, device migration, complete failure of the procedure resulting in incontinence and mild to moderate incontinence due to incomplete support or overactive bladder.
  • In addition to the above listed potential complications, allergic reaction, fistula, abscess, detrusor instability, pelvic and vaginal pain, dysparenia, vaginal bleeding, vaginal discharge, dehiscence of vaginal incision, edema, and erythema at the wound site, have been reported due to suburethral sling procedures.
  • It has also been reported that groin pain, orthostatic symptoms, fatigue and shortness of breath may occur due to the potential development of hematoma in the obturator foramen.

    • Cautions

  • Standard surgical practices should be followed for the suburethral sling procedure as well as for the management of contaminated or infected wounds.
  • The procedure should be performed with very careful attention to avoid laceration of any vessels, nerves, bladder and bowel.
  • Do not remove the protective plastic sleeve covering mesh implant until proper position has been confirmed.
  • Ensure the mesh is placed with appropriate tension under the mid-urethra.
  • Use of this device should be done with the understanding that subsequent infection may require removal of the mesh.
  • Patients should be counseled to refrain from heavy lifting, exercise, and intercourse for a minimum of four weeks after the procedure. Physician should determine when it is suitable for each patient to return to normal activities.
  • Should dysuria, bleeding or other problems occur, the patient should be instructed to contact the physician immediately.
  • Do not use any mechanical means of contact with the mesh (such as clips, staples, etc.) within the urethral support region of the mesh as mechanical damage to the mesh may occur.
  • Avoid excessive tension on the mesh during handling.

    • Prescriptive Information

    Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.

    Please refer to the Directions for Use provided with the product for complete instructions for use, contraindications, warnings and precautions.

    WARNING
    Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if sterile barrier is damaged. If damage is found, call your Boston Scientific representative.
    For single patient use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient.
    After use, dispose of product and packaging in accordance with hospital, administrative and/or local government policy.

    DEVICE DESCRIPTION
    The Solyx SIS (Single Incision Sling) System is a sterile single use system consisting of one (1) delivery device and one (1) mesh assembly. The mesh assembly is comprised of a polypropylene knitted mesh with polypropylene carriers at each end of the distal mesh. The carrier is designed to be placed on the tip of the delivery device. The disposable delivery device consists of a handle, a stainless steel shaft and a deployment mechanism. The delivery device is designed to facilitate the passage of the mesh assembly through bodily tissues for placement into the obturator internus muscle. This Product Contains No Detectable Latex.

    INDICATIONS FOR USE
    The mesh implant is intended for use as a suburethral sling for the treatment of stress urinary incontinence resulting from hypermobility and/or intrinsic sphincter deficiency.

    CONTRAINDICATIONS
    A mesh implant is contraindicated in the following patients:
    • Pregnant patients, patients with the potential for future growth or patients who are considering future pregnancies.
    • Any patients with soft tissue pathology into which the implant is to be placed.
    • Patients with any pathology which would compromise implant placement.
    • Patients with any pathology that would limit blood supply or infections that would compromise healing.


    GENERAL WARNING
    The risks and benefits of performing a suburethral sling procedure in the following patients should be carefully considered:
    • Women planning future pregnancies.
    • Overweight women (weight parameters to be determined by the physician).
    • Patients with blood coagulation disorder.
    • Patients with a compromised immune system or any other condition that would compromise healing.
    • Patients with renal insufficiency or upper urinary tract obstruction.
    Take special care in cases of bladder prolapse because of anatomical distortion. If the patient requires a cystocele repair, it should be done prior to the suburethral sling procedure. Vaginal and urinary tract infection should be treated prior to a suburethral sling implantation procedure.

    User should be familiar with surgical procedures and techniques involving nonabsorbable meshes.

    This product is intended for use only by physicians with adequate training and experience in treatment of female stress urinary incontinence (SUI). The physician is advised to consult the medical literature regarding techniques, complications and hazards associated with the intended procedures.

    PROCEDURAL WARNING

    • Cystoscopy can be done at the physician’s discretion.
    • User should note the importance of placing the mesh tension free under the mid-urethra.


    POST PROCEDURAL WARNING
    • If subsequent infection occurs, follow appropriate medical intervention practices.
    • The patient should be advised that future pregnancies may negate the effects of this procedure and the patient may again become incontinent.


    ADVERSE EFFECTS
    The following adverse events have been reported due to suburethral sling placement, but are not limited to:
    • Abscess
    • Allergic reaction
    • Bleeding
    • Bruising/Hematoma
    • Dehiscence of vaginal incision
    • Detrusor Instability
    • Dyspareunia
    • Edema/Erythema
    • Erosion/Exposure
    • Extrusion
    • Fistula
    • Hemorrhage
    • Incontinence
    • Infection
    • Inflammation
    • Irritation
    • Migration of device from desired location
    • Organ perforation
    • Overactive bladder
    • Pain


    PRECAUTIONS
    • Standard surgical practices should be followed for the suburethral sling procedure as well as for the management of contaminated or infected wounds.
    • The procedure should be performed with very careful attention to avoid laceration of any vessels, nerves, bladder and bowel.
    • Ensure the mesh is placed tension free under the mid-urethra.
    • Use of this device should be done with the understanding that subsequent infection may require removal of the mesh.
    • Physician should determine when it is suitable for each patient to return to normal activities. Patients should be counseled to refrain from heavy lifting, exercise, and intercourse after the procedure.
    • Should dysuria, bleeding or other problems occur, the patient should be instructed to contact their physician immediately.
    • Do not use any mechanical means of contact with the mesh (such as clips, staples, etc.) within the urethral support region of the mesh as mechanical damage to the mesh may occur.
    • Avoid excessive tension on the mesh during handling.
    • Urinary Retention
    • Urinary Tract Obstruction
    • Vessel/Nerve Injury
    • Vaginal Discharge
    • Sexual Dysfunction

    Prescriptive Information

    Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.

    Please refer to the Directions for Use provided with the product for complete instructions for use, contraindications, warnings and precautions.

    WARNING
    Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if sterile barrier is damaged. If damage is found, call your Boston Scientific representative. For single patient use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness, or death. reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness, or death of the patient. After use, dispose of product and packaging in accordance with hospital, administrative and/or local government policy.

    WARNING
    This product is intended for use only by clinicians with adequate training and experience in the surgical treatment of stress urinary incontinence (SUI). The physician is advised to consult the medical literature regarding techniques, complications and hazards associated with the intended procedures.

    DEVICE DESCRIPTION
    This Product Contains No Detectable Latex. The Advantage ™ System and the Advantage Fit™ System are sterile, single use systems, consisting of one delivery device and one mesh assembly. Each mesh assembly is comprised of a polypropylene knitted mesh protected by a disposable plastic sleeve. At the distal ends of the mesh assembly are two dilators designed to be placed over the shaft end of the delivery device. The disposable delivery device consists of a handle with a curved shaft, a sliding metal cannula with a blunt distal end and a pusher component. delivery device is designed to facilitate the passage of the mesh assembly through bodily tissues for transvaginal placement.

    INDICATIONS FOR USE
    The mesh implant is intended as a suburethral sling for the treatment of stress urinary incontinence resulting from hypermobility and/or intrinsic sphincter deficiency.

    CONTRAINDICATIONS
    A mesh implant is contraindicated in the following patients:
    • Pregnant patients, patients with the potential for future growth or patients that are considering future pregnancies.
    • Any patients with soft tissue pathology into which the implant is to be placed.
    • Patients with any pathology which would compromise implant placement.
    • Patients with any pathology, such as blood supply limitations or infections that would compromise healing.

    GENERAL WARNING
    The risks and benefits of performing a suburethral sling procedure in the following patients should be carefully considered:
    • Women planning future pregnancies.
    • Overweight women (weight parameters to be determined by the physician).
    • Patients with blood coagulation disorder.
    • Patients with a compromised immune system or any other condition that would compromise healing.
    • Patients with renal insufficiency or upper urinary tract obstruction.
    • Take special care in cases of bladder prolapse because of anatomical distortion. If the patient requires a cystocele repair, it should be done prior to the suburethral sling procedure.
    • Vaginal and urinary tract infection should be treated prior to a suburethral sling implantation procedure.
    • User should be familiar with surgical procedures and techniques involving nonabsorbable meshes.
    • This product is intended for use only by clinicians with adequate training and experience in treatment of female stress urinary incontinence (SUI). The physician is advised to consult the medical literature regarding techniques, complications and hazards associated with the intended procedures.
    • Good surgical practices should be followed for management of contamination or infected wounds.

    PROCEDURAL WARNING
    • User should note the importance of placing the mesh tension free under mid-urethra.

    POST PROCEDURAL WARNING
    • If subsequent infection occurs, follow appropriate medical intervention practices.
    • The patient should be advised that future pregnancies may negate the effects of this procedure and the patient may again become incontinent.

    PRECAUTIONS
    • Standard surgical practices should be followed for the suburethral sling procedure as well as for the management of contaminated or infected wounds.
    • The procedure should be performed with very careful attention to avoid laceration of any vessels, nerves, bladder and bowel.
    • Retropubic bleeding can occur. Check carefully before releasing patient from the hospital.
    • Cystoscopy must be performed to confirm bladder integrity.
    • Do not remove the protective plastic sleeve covering mesh implant until proper position has been confirmed.
    • Ensure the mesh is placed tension free under the mid-urethra.
    • Use of this device should be done with the understanding that subsequent infection may require removal of the mesh.
    • Patients should be counseled to refrain from heavy lifting, exercise, and intercourse for a minimum of four weeks after the procedure. Physician should determine when it is suitable for each patient to return to normal activities.
    • Should dysuria, bleeding or other problems occur, the patient should be instructed to contact the physician immediately.
    • Do not use any mechanical means of contact with the mesh (such as clips, staples, etc.) within the urethral support region of the mesh as mechanical damage to the mesh may occur.
    • Avoid excessive tension on the mesh during handling.

    ADVERSE EVENTS
    The following complications have been reported due to the suburethral sling placement, but are not limited to:
    • As with all implants, local irritation at the wound site and/or foreign body response may occur.
    • Tissue responses to the implant could include vaginal erosion/extrusion, erosion through the urethra or other surrounding tissue, migration of the device from the desired location, fistula formulation and inflammation. The occurrence of these responses may require removal of the entire mesh.
    • Like all foreign bodies, the mesh may potentiate an existing infection.
    • Excess tension may cause temporary or permanent lower urinary tract obstruction and retention.
    • Perforation or laceration of vessels, nerves, bladder, urethra or bowel may occur during placement and may require surgical intervention.
    • Known risks of surgical procedures for the treatment of incontinence include pain, infection, erosion of the vaginal or urethral mucosa or bladder wall, device migration, complete failure of the procedure resulting in incontinence and mild to moderate incontinence due to incomplete support or overactive bladder.
    • In addition to the above listed potential complications, allergic reaction, fistula, abscess, detrusor instability, pelvic and vaginal pain, dyspareunia, vaginal bleeding, vaginal discharge, dehiscence of vaginal incision, bruising/hematoma, edema and erythema at the wound site, have been reported due to suburethral sling procedures.

    Prescriptive Information

    Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.

    Please refer to the Directions for Use provided with the product for complete instructions for use, including Indications for Use, Contraindications, Warnings, Precautions, Adverse Events and Instructions, prior to using this product.

    INTENDED USE/INDICATIONS FOR USE
    The Uphold Vaginal Support System is indicated for tissue reinforcement and 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.

    DEVICE DESCRIPTION
    The Uphold Vaginal Support System is a sterile, single use device for transvaginal placement, consisting of (1) one Uphold Synthetic Mesh Assembly and (1) one Capio™ Suture Capturing Device. The mesh assembly is a polypropylene knitted mesh with 2 integrated leg assemblies. The leg assemblies include a needle, lead, dilator and protective sleeve. The needle at the distal end of the leg assembly was designed to be placed into the needle carrier at the distal end of the Capio Suture Capturing Device. The leg assembly was designed to facilitate the passage of the Uphold Synthetic Mesh Assembly through bodily tissues for placement through the sacrospinous ligament. One of the dilators is striped to differentiate left from right side.

    CONTRAINDICATIONS
    The Uphold Synthetic Mesh is contraindicated for use in any patient in whom soft tissue implants are contraindicated. In addition patients with:
    • Pathology of the soft tissue into which the Uphold Synthetic Mesh is to be placed.
    • Pregnant patients, or patients that are considering future pregnancies.
    • The potential of future growth (e.g. infants, children).
    • Any pathology, including known or suspected uterine pathology, which would compromise implant placement.
    • Any pathology that would limit blood supply and compromise healing.
    • Blood coagulation disorder.
    • Autoimmune connective tissue disease.
    • Renal insufficiency and upper urinary tract obstruction.
    • Pre-existing local or systemic infection. Treat the infection with the appropriate antiseptics and/or antibiotics to eliminate the infection before placing the Uphold Synthetic Mesh.


    WARNINGS/POTENTIAL COMPLICATIONS
    • Hysterectomy may be needed in the future; Use of mesh may make future hysterectomies more difficult due to tissue in-growth and scarring.
    • Cervical length must be evaluated during the preoperative workup; Patients with cervical elongation may not be appropriate candidates for apical repair procedures; Cervical amputation may be considered for patients with cervical elongation who choose to undergo the procedure.
    • Continued screening and surveillance for cervical and uterine disease may be required; Regular pelvic exam, Pap test and endometrial biopsies should be continued as medically indicated.
    • Performing apical repair for cases involving uterine enlargement, in the presence of benign disease, should be at the physician’s discretion; An enlarged uterus may compromise the effectiveness of the procedure in some cases.
    • Should dysuria, bleeding or other problems occur, the patient should be instructed to contact the physician immediately.
    • Patients should be counseled to refrain from heavy lifting, exercise and intercourse for a minimum of six (6) weeks after the procedure. Physician should determine when it is suitable for each patient to return to normal activities.
    • In the event that infection presents post procedure, the entire mesh may have to be removed or revised.
    • Like all foreign bodies, the mesh may potentiate an existing infection reaction or sepsis.
    • Tissue responses to the implant could include local irritation at the wound site, vaginal erosion or exposure though the urethra or other surrounding tissue, migration of the device from the desired location, fistula formation, foreign body reaction, and inflammation. The occurrence of these responses may require removal or revision of the mesh.
    • Mild to moderate incontinence may occur due to incomplete support.
    • Excess tension may cause temporary or permanent lower urinary tract obstruction and retention.
    • Known risks of surgical procedures for the treatment of prolapse include pain, infection, erosion/exposure, device migration, complete failure of the procedure resulting in recurrent or de Novo prolapse and/or incontinence.
    • Punctures or lacerations of vessels, nerves, bladder, urethra, or bowel may occur during placement and may require surgical repair.
    • A digital rectal exam should be performed to detect possible rectal perforation.
    • Cystoscopy is recommended to confirm bladder integrity or detect possible bladder or ureteral perforation.
    • Overweight women may be prone to intraoperative and postoperative complications (weight parameters to be determined by the physician).

    PRECAUTIONS
    • Surgical treatment of female pelvic organ prolapse should be performed by clinicians with adequate training and experience.
    • Training on the use of the Uphold Apical/Anterior Vaginal Support System is recommended and available. Contact your company sales representative to arrange for this training.
    • The physician is advised to consult this DFU and the medical literature regarding techniques, complications and hazards associated with the intended procedures.
    • Individual patients’ anatomy may vary greatly, for each procedure it is important that the intended planes for mesh placement and the intended location for leg placement are planned and known for each individual patient. Employment of imaging methods before and after mesh placement may aid in proper mesh placement and confirm absence of injury to nontarget anatomical structures.
    • Standard surgical practices should be followed for pelvic floor procedures as well as for the management of contaminated or infected wounds.
    • The procedure should be performed with care, using the Capio™ Device provided with the kit, to avoid puncture or laceration of any vessels, nerves, bladder, urethra and bowel.
    • Avoid excessive tension on the mesh during handling and positioning to prevent damage to the device.
    • Do not remove the protective plastic sleeve covering mesh legs until proper position has been confirmed.
    • Avoid excess tensioning of the mesh when positioning to avoid over correction of the defect.
    • Take special care in cases of bladder prolapse because of anatomical distortion.
    • Use only size 0 Capio Sutures with the Capio Suture Capturing Device.
    • Do not affix mesh with any staples, clips, or clamps as mechanical damage to the mesh may occur.

    ADVERSE EVENTS
    Potential adverse reactions that may be associated with surgically implanted materials include:
    • Abscess formation/Foreign body reaction;
    • Adhesion formation;
    • Allergic, hypersensitivity or other immune reaction;
    • Bruising, hematoma, hemorrhage;
    • Constipation;
    • Dehiscence and/or necrosis;
    • Dyspareunia;
    • Erosion/extrusion;
    • Fistula formation;
    • Granulation tissue formation;
    • Infection/Sepsis potentiation;
    • Inflammation (acute or chronic);
    • Mesh and/or tissue contracture;
    • Organ perforation;
    • Pain, discomfort, irritation;
    • Post-operative bleeding;
    • Recurrent prolapse;
    • Surgical site wound irritation, erythema, edema;
    • Ureteric injury;
    • Ureter Obstruction;
    • Urinary Incontinence;
    • Urinary retention;
    • Vaginal discharge;
    • Vaginal shortening or stenosis;
    • Vessel/Nerve injury/perforation;
    • Wound dehiscence.

    Prescriptive Information

    Refer to Directions for Use provided with this product for complete instructions, warnings, and precautions prior to using this product.
    Indications

    The Capio CL Suture Capturing Device is intended for use in a variety of transvaginal procedures to place sutures in Cooper's Ligament for the correction of female urinary stress incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

    Contraindications

    The Capio CL Suture Capturing Device is contraindicated when, in the judgment of the physician, the procedure would be contrary to the best interests of the patient; and for placing sutures into or through bone.

    Warnings

    For single use only. Do not reuse, reprocess or resterilize. Use only needles and sutures specified for use with the Capio CL Suture Capturing Device. The Capio CL Suture Capturing Device is not intended to be used as a tissue, organ or bone manipulator.

    Potential Adverse Effects

    The potential adverse effects which may result from suture placement procedure include, but are not limited to: injury to internal vessels and nerves, bleeding, hematoma, inflammatory reaction to the suture material or to the trauma of being sutured.

    Cautions

    Federal (USA) law and governing law outside the USA restrict these devices to sale by or on the order of a physician.


    Prescriptive Information

    Indications

    The Precision SpeedTac Device is indicated for soft tissue attachment to the pelvic bone for the correction of urinary incontinence as a result of intrinsic sphincter deficiency (ISD) and/or hypermobility. It is designed for transvaginal placement of bone anchors to suspend sutures and/or place a sling.

    Contraindications

    The Precision SpeedTac Device is contraindicated for use in any patient in whom bone anchor attachment to suspend suture or place a sling are contraindicated. These patients include, but are not limited to, those with osteopenia, a pelvic bone thickness of less than 8mm, communited bone surface, pathology of soft tissue, a known sensitivity to implant materials, blood supply limitation or infection, renal insufficiency or upper urinary tract, and future plans for pregnancy.

    Warnings

    For single use only. Do not reuse, reprocess or resterilize.

    Potential Adverse Effects

    Potential adverse effects which may occur from a transvaginal anchor procedure include, but are not limited to, loss of fixation, pullout of bone anchors, difficult bone penetration, metal sensitivity, cancer, wound dehiscence, calculi formation in the urinary and biliary tracts, enhanced bacterial infectivity, minimal acute inflammatory tissue reaction, pain, edema, and erythema at the wound site.

    Cautions

    Federal (USA) law and governing law outside the USA restrict this device to sale by or on the order of a physician.

    Prescriptive Information

    Indications

    The mesh implant is intended for use as a suburethral sling for the treatment of stress urinary incontinence resulting from hypermobility and/or intrinsic sphincter deficiency.

    Contraindications

    A mesh implant is contraindicated in the following patients:

    • Pregnant patients, patients with the potential for future growth or patients that are considering future pregnancies.
    • Any patients with soft tissue pathology into which the implant is to be placed.
    • Patients with any pathology which would compromise implant placement.
    • Patients with any pathology, such as blood supply limitations or infections that would compromise healing.

    Warnings

    GENERAL WARNING:

    • The risks and benefits of performing a suburethral sling procedure in the following patients should be carefully considered:
    • Women planning future pregnancies.
    • Overweight women (weight parameters to be determined by the physician).
    • Patients with blood coagulation disorder.
    • Patients with a compromised immune system or any other condition that would compromise healing.
    • Patients with renal insufficiency or upper urinary tract obstruction.
    • Take special care in cases of bladder prolapse because of anatomical distortion. If the patient requires a cystocele repair, it should be done prior to the suburethral sling procedure.
    • Vaginal and urinary tract infection should be treated prior to a suburethral sling implantation procedure.
    • User should be familiar with surgical procedures and techniques involving nonabsorbable meshes.
    • This product is intended for use only by clinicians with adequate training and experience in treatment of female stress urinary incontinence (SUI). The physician is advised to consult the medical literature regarding techniques, complications and hazards associated with the intended procedures.
    • Good surgical practices should be followed for management of contamination or infected wounds.
    PROCEDURAL WARNING:
    • Cystoscopy is not required, but can be done at the surgeon’s discretion.
    • User should note the importance of placing the mesh without tension under mid-urethra.
    POST PROCEDURAL WARNING:
    • If subsequent infection occurs, follow appropriate medical intervention practices.
    • The patient should be advised that future pregnancies may negate the effects of this procedure and the patient may again become incontinent.

    Potential Adverse Effects

    The following complications have been reported due to suburethral sling placement, but are not limited to:

    • As with all implants, local irritation at the wound site and/or a foreign body response may occur.
    • Tissue responses to the implant could include vaginal erosion/extrusion, erosion through the urethra or other surrounding tissue, migration of the device from the desired location, fistula formation and inflammation. The occurrence of these responses may require removal of the entire mesh.
    • Like all foreign bodies, the mesh may potentiate an existing infection. Excess tension may cause temporary or permanent lower urinary tract obstruction and retention.
    • Known risks of surgical procedures for the treatment of incontinence include pain, infection, erosion, device migration, complete failure of the procedure resulting in incontinence and mild to moderate incontinence due to incomplete support or overactive bladder.
    • In addition to the above listed potential complications, allergic reaction, fistula, abscess, detrusor instability, pelvic and vaginal pain, dyspareunia, vaginal bleeding, vaginal discharge, dehiscence of vaginal incision, edema, and erythema at the wound site, have been reported due to suburethral sling procedures.
    • Sexual dysfunction is a potential risk with this procedure.

    Cautions

    • Standard surgical practices should be followed for the suburethral sling procedure as well as for the management of contaminated or infected wounds.
    • The procedure should be performed with very careful attention to avoid laceration of any vessels, nerves, bladder and bowel.
    • Do not remove the protective plastic sleeve covering mesh implant until proper position has been confirmed.
    • Ensure the mesh is placed with minimum tension under the mid-urethra.
    • Use of this device should be done with the understanding that subsequent infection may require removal of the mesh.
    • Patients should be counseled to refrain from heavy lifting, exercise, and intercourse for a minimum of four weeks after the procedure. Physician should determine when it is suitable for each patient to return to normal activities.
    • Should dysuria, bleeding or other problems occur, the patient should be instructed to contact the physician immediately.
    • Do not use any mechanical means of contact with the mesh (such as clips, staples, etc.) within the urethral support region of the mesh as mechanical damage to the mesh may occur.
    • Avoid excessive tension on the mesh during handling.

    CAUTION: Federal law (USA) restricts the device to sale, distribution and use by or on the order of a physician. Refer to the Directions for Use provided with this product for complete instructions, warnings and precautions prior to using this product.

    Trademark

    © 2007 Boston Scientific Corporation or its affiliates. All rights reserved.

    Prescriptive Information

    Indications

    The Precision Twist Transvaginal Anchor System is indicated for use during urinary incontinence repair procedures that require placement of a bone anchor for transvaginal placement of suspending sutures and/or placement of a sling.

    Contraindications

    The Precision Twist Transvaginal Anchor System is contraindicated for use in any patient in which bone anchor attachment and/or suspending suture placement, and/or sling placement is contraindicated.

    Warnings

    For single use only. Do not reuse, reprocess or resterilize.

    Potential Adverse Effects

    Potential adverse effects which may result from a bone anchor/suspending suture and/or sling procedure to support soft tissue to treat urinary incontinence include adverse body reactions including cancer to a variety of metals, polymers, chemicals, and other materials utilized with implants. Metal sensitivity has been reported following exposure to orthopedic implants. Overcorrecting may cause temporary or permanent lower urinary tract obstruction. Loss of suture support may produce dehiscence at the implant wound site.

    Cautions

    Federal (USA) law and governing law outside the USA restrict this device to sale by or on the order of a physician.

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    Advantage System De-tanged Mesh Capio® Suture Capturing Device Loading Mesh Assembly Step 1 Mesh Assembly