AMS 700™ Inflatable Penile Prosthesis

Surgery-Related

• Improper reservoir placement or filling technique can result in spontaneous unintended inflation or deflation of the cylinders that may result in unintended partial or full erections.
• Migration of the device components can occur if the cylinders are improperly sized, if the pump or the reservoir is not positioned properly, or if the tubing lengths are incorrect.
• Improper measurement technique, positioning, or sizing may reduce cylinder life.
• Implantation of AMS 700 LGX™ cylinders in patients with Peyronie’s disease may not provide a satisfactory result.

Device-Related

• Quick Connect Window Connectors, provided in the AMS 700 IPP Accessory Kit, should not be used in revision procedures involving previously implanted component tubing. In this situation the Quick Connect Window Connectors may be less effective.
• The stainless-steel tubing plug in the AMS 700 IPP Accessory Kit contains nickel, which may cause an allergic reaction in individuals with nickel sensitivity.
• The AMS 700 Inflatable Penile Prothesis should be filled with sterile normal saline. Some patients may have a hypersensitivity to contrast media.
• CXR RTEs are not compatible with CX or LGX cylinders. CX/LGX RTEs are not compatible with CXR cylinders.
• Verify proper attachment of RTEs by spinning them once seated. Properly attached RTEs should spin freely without accidental disengagement or material bulging.
• Do not stack the CX, LGX, or CXR RTEs with the exception of the 1.5 cm RTE. The locking ring on all other RTE lengths will not engage with the smooth outer surface of the RTE, which may result in the RTE disconnecting.

Patient-Related

• Trauma to the pelvic or abdominal areas, such as impact injuries associated with sports (e.g., bicycle riding), may result in damage or malfunction of the prosthesis and/or surrounding tissues, which may necessitate surgical correction, including replacement of the device.
• The contour, elasticity, and dimension of the tunica albuginea may limit the length and/or diameter expansion of the AMS 700 Inflatable Penile Prosthesis cylinders.
• Use of injection therapy concurrently with the penile prosthesis may damage the prosthesis. Patients should not use injection therapy after they receive their implant.

Inhibizone™ Related

• The AMS 700 IPP with InhibiZone is impregnated with a combination of rifampin and minocycline HCl. The contraindications, warnings, and precautions regarding the use of these antimicrobial agents apply and should be adhered to 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 the AMS 700 with InhibiZone should be carefully considered in patients with hepatic or renal disease, as rifampin and minocycline HCl can cause additional stress on the hepatic or renal systems.
• Patients who receive an AMS 700 with InhibiZone and are also taking methoxyflurane should be carefully monitored for signs of renal toxicity.
• Patients who receive an AMS 700 with InhibiZone and are also taking warfarin should have their prothrombin time monitored, because tetracyclines have been reported to slow coagulation.
• Use of the AMS 700 IPP 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.
• InhibiZone should not come into contact with ethyl alcohol, isopropyl alcohol or other alcohols, acetone or other nonpolar 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 in a sterile solution immediately prior to implantation, if desired.

Precaution specific to the MS Pump IFU:

• The risk, if any, from temporary exposure to the InhibiZone antibiotics on male fertility 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.

A clinical trial was conducted to determine the safety and effectiveness of the AMS 700™ IPP. This trial involved only devices without InhibiZone™. A total of 300 patients were enrolled with follow-up out to 5 years for 126 patients. There were 18 patient deaths during the trial. No deaths that occurred during the duration of the clinical study were attributed to the device implantation or use.

The Adverse Device Events (ADE), detailed in Tables 5 and 6 (of the IFUs) were noted during the duration of this clinical trial for all enrolled patients.

• Urogenital Pain (Typically Associated with Healing Process)
• Urogenital Edema
• Urogenital Ecchymosis
• Reservoir Encapsulation (persistent in 11/19 cases)
• Patient Dissatisfaction (With Length, Ability to Use and Nonspecific Reasons)
• Auto-Inflation
• Mechanical Malfunction (Leaks, Incomplete Inflation/Deflation, Kinking)
• Urination Impaired (Slow Stream, Split Stream, Voiding Difficulties or Obstructive Symptoms)
• Urogenital Erythema
• Joint Pain, Swelling, or Stiffness
• Decreased Penile Sensation
• Urogenital Hematoma
• Abnormal Ejaculation (Delayed, Burning, or General Nonspecific Problems)
• Infection
• Dysuria
• Penile Curvature
• Application Site Reaction (Wound Separation, Delay in Cutaneous Closure)
• Erosion/Extrusion (Pump/Cylinder)
• Paresthesia
• Urogenital Inflammation
• Adhesion of the Pump/Scrotum
• Device Malposition
• Device Migration (Pump/Cylinder)
• Transient Urinary Retention
• Urinary Frequency
• Weakness
• Abnormal Sexual Function
• Device Cylinder Aneurysm/Bulge
• Dizziness
• Dry Mouth
• Hematuria
• Low Grade Fever
• Memory Difficulties
• Pelvic Pain
• Rheumatoid Arthritis
• Other

The following “Other” adverse device events (in alphabetical order) each occurred in less than 0.5% of the patients:

• Alopecia
• Back Pain
• Cellulitis
• Depression
• Diabetes Mellitus
• Epigastric Pain
• Eye Disorder
• Eye Pain
• Fecal Incontinence
• Fibrosis
• Glans Hypermobile Dorsally
• Kidney Calculus
• Libido Decreased
• Migraine
• Necrosis
• Phimosis
• Photosensitivity Reaction
• Pump Fixation
• Thickening of the Skin
• Urinary Tract Infection
• Urinary Urgency
• Vertigo

The following adverse events (in alphabetical order) may have been associated with the use of this product:

• Bleeding
• Cavernosal Crossover
• Exposure to Biohazardous Material
• Granuloma Formation
• Ischemia
• Non-Rheumatoid Arthritis Immune-Related Tissue Disorders
• Pain (which may be prolonged or severe)
• Perforation or Injury of Bladder, Corpus Cavernosum, Nerve, Tunica, or Urethra
• Prolonged Procedure
• Seroma
• Thrombosis
• Ulceration
• Unretrieved Device Fragment
• Vascular Compromise
• Ventral Chordee
• Vessel Trauma