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Product
AMS 800™ Artificial Urinary Sphincter - IFU number 51266569-01
Rx Statement
CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. Only physicians with advanced training in urology, and management of patients in need of an artificial urinary sphincter, shall implant the AMS 800 AUS.
Prior to use, please refer to all applicable “Instructions for Use” for more information on Intended Use/Indications for Use, Contraindications, Warnings, Precautions, Potential Adverse Events, and Operator’s Instructions.
Intended Use
The AMS 800 Artificial Urinary Sphincter inflated cuff applies circumferential pressure on the urethra to increase urethral resistance to urinary flow.
Indications for Use
The AMS 800 Artificial Urinary Sphincter is used to treat urinary incontinence due to reduced outlet resistance (intrinsic sphincter deficiency) following prostate surgery.
Contraindications
- This device is contraindicated in patients whom the physician determines to be poor candidates for surgical procedures and/or anesthesia due to physical or mental conditions.
- This device is contraindicated in patients with urinary incontinence due to or complicated by an irreversibly obstructed lower urinary tract.
- This device is contraindicated in patients with irresolvable detrusor hyperreflexia or bladder instability.
- The implantation of the InhibiZone™ version of this device is contraindicated in patients with known allergy or sensitivity to rifampin or to minocycline HCl or other tetracyclines.
- The implantation of products with InhibiZone is contraindicated in patients with systemic lupus erythematosus because minocycline HCl has been reported to aggravate this condition
Warnings
Surgery-Related
- Erosion may be caused by infection, pressure on the tissue, improper cuff sizing, improper balloon selection, tissue damage, and component malposition. Failure to evaluate and promptly treat erosion may result in substantial worsening of the condition, leading to infection and/or loss of tissue.
- The implanter should check that there is an adequate amount of bulbospongiosus muscle to surround and support a bulbous urethral cuff implant. Thinner spongiosum typically occurs toward the distal end of the bulbous urethra, and implantation of the cuff where the spongiosum is thin increases the chance of erosion and other complications. This warning is especially important for double cuff implants, where the second cuff is placed distal to the first implanted cuff.
Patient-Related
- Poor bladder compliance or a small fibrotic bladder may require some measure of intervention including, in some cases, augmentation cystoplasty before implanting the prosthesis.
- Patients with urge incontinence, overflow incontinence, detrusor hyperreflexia or bladder instability should have these conditions treated and controlled (or resolved) prior to implantation of the device, as these conditions may inhibit proper functioning of the device.
- This device contains solid silicone elastomers. The risks and benefits of implanting this device in patients with documented sensitivity to silicone should be carefully considered.
- Previous patient history of an adverse reaction to any radiopaque solution precludes their use as a filling medium for the prosthesis. Instead, sterile normal saline should be used to fill the device.
- Contrast media are contraindicated if the patient has an iodine allergy.
Post-Procedural
- Do not pass a catheter or any other instrument through the urethra without first deflating the cuff and deactivating the device, to prevent potential damage to the urethra or the AMS 800 AUS.
- Adequate manual dexterity, strength, motivation, and mental acuity are required for proper use of the device. Surgical complications, or physical or psychological complications (such as any progressively degenerative disease), if they occur, may affect the use of the system. Continued improper use may necessitate removal of the prosthesis.
- If a hypersensitivity reaction develops to a device treated with InhibiZone, the cuff and pump should be removed, and the patient treated appropriately.
Precautions
Surgery-Related
- Improper cuff sizing, improper balloon selection, or other causes may result in tissue erosion, migration of components, or continued incontinence.
- Tubing kinks may result if the connecting tubing is cut to an improper length during the implant procedure.
Device-Related
- Quick Connect Window Connectors should not be used in revision procedures involving previously implanted component tubing. Suture-Tie Connectors should be used in revision procedures. The Quick Connect system may be used in revision surgeries when all previously implanted components are removed and replaced with new components.
- The stainless steel tubing plugs in the Deactivation Package contain nickel, which may cause an allergic reaction in individuals with nickel sensitivity. Prior to implantation, patients should be counseled on the materials contained in the device, as well as potential for allergy/hypersensitivity to these materials.
- If the deactivation valve is closed when the cuff is inflated, fluid cannot transfer from the cuff to the balloon and sustained outflow obstruction may occur. In the event of large pressures within the bladder, automatic pressure relief that normally occurs with the device would be prevented. Cycling the device can relieve the outflow obstruction. Cycling the device may be difficult if deactivation occurs when the pump bulb is deflated. If unable to cycle the device, squeezing the sides adjacent to the deactivation button will allow fluid to fill the pump bulb and then the pump can be cycled normally. Release of the deactivation valve may require greater pressure than that used to cycle the device.
- System pressure changes may occur over time if the balloon is filled with radiopaque solution of incorrect concentration. Follow the instructions in the Filling Solutions section to prepare the radiopaque solution in the correct concentration.
Patient-Related
- Tissue fibrosis, previous surgery, or previous radiation therapy in the area of the implant may preclude implantation of a cuff.
- Trauma or injury to the pelvic, perineal or abdominal areas, such as impact injuries associated with sports, can result in damage to the implanted device and/or surrounding tissues. This damage may result in the malfunction of the device and may necessitate surgical correction including replacement of the device.
- Consideration should be given to the diameter of the implanted occlusive cuff relative to catheters or other trans-urethral devices. When fully deflated, the inside diameter of the smallest occlusive cuff (3.5 cm) generally exceeds 28F. Additional clearance is required to accommodate the patient’s urethral tissue between the trans-urethral device and the occlusive cuff. Urethral tissue thickness is patient specific and requires a physician’s assessment to determine its impact on sizing.
InhibiZone™ related
- Components with InhibiZone are treated with a combination of rifampin and minocycline HCl. The contraindications, warnings, and precautions regarding the use of these antimicrobial agents apply, and should be followed for the use of this device, although systemic levels of minocycline HCl and rifampin in patients receiving this device are unlikely to be detected.
- Use of products with InhibiZone should be carefully considered in patients with hepatic or renal disease, as use of rifampin and minocycline HCl can cause additional stress on the hepatic and renal systems.
- Patients who receive a device with InhibiZone and are also taking methoxyflurane should be carefully monitored for signs of renal toxicity.
- Patients who receive a device with InhibiZone and are also taking warfarin should have their prothrombin time monitored because tetracyclines have been reported to slow coagulation.
- Use of products with InhibiZone should be carefully considered in patients using thionamides, isoniazid, and halothane, due to potential hepatic side effects that have been reported in patients using these drugs and higher doses of rifampin.
- Devices with InhibiZone should not come into contact with ethyl alcohol, isopropyl alcohol or other alcohols, acetone, or other non-polar solvents. These solvents may remove the antibiotics from the device.
- InhibiZone components should not be soaked in saline or other solutions prior to implantation. The components may be briefly rinsed or dipped into a sterile solution, immediately prior to implant, if desired.
- The risk, if any, from temporary exposure to the InhibiZone antibiotics on the fertility of men is unknown and must be weighed against the benefit of using an InhibiZone-treated device (instead of a non-InhibiZone device) to mitigate the risk of infection during device implantation.
Refer to Instructions for Use for all applicable information on Precautions.
Potential adverse events
Below lists the device related adverse events reported during the clinical study. This trial involved only devices without InhibiZone.
- Impaired Device Function
- Pain/Discomfort
- Delayed Wound Healing
- Bladder Spasms
- Difficult Activation
- Migration
- Tissue Erosion
- Difficult Deactivation
- Infection
- Recurrent Incontinence
- Fistula Formation
- Hematoma
- Swelling
- Hydrocele
- Patient Dissatisfaction
- Positional Incontinence
- Urinary Retention
Additional, Adverse events potentially related to the implantation and use of the AMS 800 AUS include:
- Adhesion
- Allergic reaction
- Contracture
- Deep vein thrombosis
- Dehiscence
- Dysuria
- Erosion
- Exposure to biohazardous material
- Fibrosis
- Foreign body/unretrieved device fragment
- Hematuria
- Hemorrhage/bleeding
- Herniation of the device through tissue
- Limited urethral coaptation (may be due to device leak, sizing, malfunction, placement, or other causes)
- Malfunction
- Malposition of components
- Mechanical malfunction or mechanical difficulty
- Overactive bladder
- Prolonged procedure
- Unintended surgical damage (perforation or injury to the bladder, urethra, nerves, vessels, or other local structures)
- Urethral atrophy
- Urethral stricture
- Urinary retention
- Urinary urgency
- Delayed wound healing.
Additional adverse events include-
- Device damage - unrelated procedure
- Early post-operative morbidity
- Incisional hernia
- Phlebitis
- Pulmonary embolus
- Upper urinary tract deterioration
- Wound seroma
- Hydrocele
Adverse events may require additional medical or surgical intervention.
Medical interventions included: medication, education, frequent device deactivation, dressing changes and catheterization.
Caution: U.S. Federal law restricts this device to sale by or on the order of a physician.
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