ACT® Brief Summary of Safety Information for Physicians

Indications: The ACT system is indicated for use in the correction of stress urinary incontinence in females.

Contraindications: Contraindications include active systemic or urinary tract infections, pregnancy, unmanageable detrusor instability, reduced bladder compliance, pretreatment urge incontinence symptoms refractory to medication, residual volume greater than 100 ml after voiding, pelvic-region radiotherapy within 6 months of ACT system implantation, bladder cancer or bladder stones, bleeding disorders.

Warnings/Precautions/Adverse Events: The ACT device is intended for single use only. Do not re-sterilize. Resterilization could result in mechanical failure of the device and place the patient at undue risk. Placement of the ACT device must be performed by a physician. If X-ray is used, adequate attention must be given to the potential radiation exposure. Perforation of the bladder, urethra or vagina during dilation of the tissue from the labia to the bladder neck should be avoided. Do not use excessive force to advance or withdraw the device if resistance is encountered. Do not attempt to place or introduce the device without the supplied push wire. Do not place the device in a location where the patient may have problems with urinary retention or erosion. Do not place the device immediately adjacent to the urethral mucosa. This could result in balloon erosion or migration. Do not place the device in a location where there are surgical staples, steel suture or other artifacts from previous interventions. Device wear and/or puncture may result. Do not inflate the balloon with more than 8.0 ml of isotonic contrast solution. Use the correct mixture of sterile water and contrast media to provide an isotonic contrast solution for inflation of the ACT balloons. Do not use the implantation instruments without prior cleaning and steam sterilization. The ACT system should only be used by a physician who has completed appropriate training. Patients should be pre-medicated with an antibiotic to reduce the possibility of postoperative infection. If ACT balloon failure, or bladder, urethra or vaginal wall perforation occur, do not implant and ACT device on the affected side for at least sixty days. An effective procedure calls for two devices to be placed. If the patient becomes pregnant after ACT implantation, the primary physician must closely monitor the patient for any adverse effects associated with the device during pregnancy. Failure of the device may result if the ACT device is handled with any sharp instruments or laid against an abrasive material. ACT balloons should be filled with saline instead of isotonic contrast solution if the patient is allergic to contrast media. It is advisable to use the same type of contrast media as used during the original filling of the balloons when performing a post surgical adjustment. The patient should refrain from heavy lifting and exercise for 3 to 4 weeks postoperatively and refrain from intercourse for one month. Advise the patient to contact the surgeon immediately if bleeding or other problems occur. Potential adverse events include, but are not limited to tissue perforation (tear), device migration, tissue erosion/infection at the implant site, device failure, non-response to treatment, post-operative urgency, frequency or retention.

Rx Only.

ProACT™ Brief Summary of Safety Information for Physicians

Product Technical manual must be reviewed prior to use for detailed disclosure.

Indications: The ProACT system is indicated for use in the correction of stress urinary incontinence in males arising from intrinsic sphincter deficiency following an operation performed on the prostate for cancer or for BPH.

Contraindications: Contraindications include active systemic or urinary tract infections, unmanageable detrusor instability, reduced bladder compliance, residual volume greater than 100 ml after voiding, pelvic-region radiotherapy within 6 months of ACT system implantation, bladder cancer, unsuccessfully treated bladder stones, hemophilia or bleeding disorders.

Warnings/Precautions/Adverse Events: The ProACT device is intended for single use only. Do not re-sterilize. Resterilization could result in mechanical failure of the device and place the patient at undue risk. Placement of the ProACT device must be performed by a physician. If X-ray is used, adequate attention must be given to the potential radiation exposure. Perforation of the bladder, urethra or rectum during dilation of the tissue from the perineal area to the bladder neck should be avoided. Do not use excessive force to advance or withdraw the device if resistance is encountered. Do not attempt to place or introduce the device without the supplied push wire. Do not place the device in a location where the patient may have problems with urinary retention or erosion. Do not inflate the balloon with more than 8.0 cc. Do not place the device immediately adjacent to the urethral mucosa. This could result in balloon erosion or migration. Use the correct mixture of sterile water and contrast media to provide an isotonic contrast solution for inflation of the ACT balloons. Do not use the implantation instruments without prior cleaning and steam sterilization. Do not place the device in a location where there are surgical staples, steel suture or other artifacts from previous interventions. Device wear and/or puncture may result. The ACT system should only be used by a physician who has completed appropriate training. Patients should be pre-medicated with an antibiotic to reduce the possibility of postoperative infection. If bladder perforation occurs, do not implant the ProACT device on the affected side for at least sixty days. An effective procedure calls for two devices to be placed. Failure of the device may result if the ACT device is handled with any sharp instruments or laid against an abrasive material. Do not grasp the port or strain relief with clamps. ProACT balloons should be filled with saline instead of isotonic contrast solution if the patient is allergic to contrast media. It is advisable to use the same type of contrast media as used during the original filling of the balloons when performing a post surgical adjustment. Potential adverse events include, but are not limited to tissue perforation (tear), device migration, post-operative urgency, frequency or retention, tissue erosion/infection at the implant site, device failure, and non-response to treatment.

Rx Only.