ACT® Brief Summary of Safety Information for Patients
Patients should always discuss the potential risks and benefits with a physician.
Indications (when to use): The ACT system is indicated for use in the correction of stress urinary incontinence in females.
Contraindications (when not to use): 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. 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, the ACT device should not be implanted 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. ACT balloons should be filled with saline instead of isotonic contrast solution if the patient is allergic to contrast media. Refrain from heavy lifting and exercise for 3 to 4 weeks postoperatively and refrain from intercourse for one month. Contact the surgeon immediately if bleeding or other problems occur.
Potential adverse events include, but are not limited to tissue perforation (tear), device migration (movement), tissue erosion or infection at the implant site, device failure, non-response to treatment, post-operative urgency, frequency or retention.
Patients should always discuss the potential risks and benefits with a physician.
Indications (when to use): The ACT system is indicated for use in the correction of stress urinary incontinence in females.
Contraindications (when not to use): 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. 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, the ACT device should not be implanted 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. ACT balloons should be filled with saline instead of isotonic contrast solution if the patient is allergic to contrast media. Refrain from heavy lifting and exercise for 3 to 4 weeks postoperatively and refrain from intercourse for one month. Contact the surgeon immediately if bleeding or other problems occur.
Potential adverse events include, but are not limited to tissue perforation (tear), device migration (movement), tissue erosion or infection at the implant site, device failure, non-response to treatment, post-operative urgency, frequency or retention.