Important safety information

The AMS 700^TM Inflatable Penile Prosthesis (IPP) is intended for use in the treatment of chronic, organic male erectile dysfunction (impotence). 

With all medical procedures, there are risks associated with the procedure and the use of the device, including long-term implantation.

Implanting a penile prosthesis will damage or destroy any remaining ability to have a natural erection, as well as make other treatment options (oral medications, vacuum devices or injections) impossible.  Men with diabetes, spinal cord injuries or open sores may have an increased risk of infection. Implantation may result in penile curvature or scarring. The device is not suitable for patients with active urinary tract, genital or skin infections in the region of surgery. Some AMS 700 devices contain an antibiotic (InhibiZone™ Antibiotic Surface Treatment). AMS 700 with InhibiZone is not suitable for patients who are allergic to the antibiotics contained within the device (rifampin and minocycline HCl) or other tetracyclines, or for patients with systemic lupus, so devices that do not contain InhibiZone should be considered for these patients. 

The risks include but are not limited to: device malfunction/failure leading to additional surgery, device migration potentially leading to exposure through tissues, wearing away/loss of tissue (device/tissue erosion), infection, unintended-inflation of the device, pain/soreness, redness or rash near the incision or scrotum, swelling near the incision, scrotum or penis, hives, fever, problems with urination, device in an inappropriate position (device malposition). A second surgery may be required to reposition or remove the reservoir (reservoir revision or removal).

The device can be MRI scanned under specific conditions. Scanning under other conditions may result in injury or device malfunction. Be sure to talk to your doctor before undergoing MRI scanning.

Be sure to talk with your doctor so that you thoroughly understand all of the risks and benefits associated with the use of the device.

The AMS 800 AUS is used to treat urinary incontinence due to reduced urethral/bladder outlet resistance (intrinsic sphincter deficiency) in adult males and females.

With all medical procedures, there are risks associated with the procedure and the use of the device.

Patients with urinary tract infections, diabetes, spinal cord injuries, open sores, or skin infections in the region of the surgery have an increased risk of infection. The device is not suitable for patients with active urinary tract, genital or skin infections in the region of surgery. Some AMS 800 devices contain an antibiotic (InhibiZone™ Antibiotic Surface Treatment). AMS 800 with InhibiZone is not suitable for patients who are allergic to the antibiotics contained within the device (rifampin and minocycline HCl) or other tetracyclines, or for patients with systemic lupus, so devices that do not contain InhibiZone should be considered for these patients.

The risks include but are not limited to:

Allergic reaction, erosion (wearing away or a state of being worn away, as by friction or pressure resulting in a breakdown of tissue), limited urethral coaptation (limited closing of the urethra) which may be due to device leak, sizing, malfunction placement, or other causes, device malfunction/failure leading to additional surgery, malposition of parts (parts placed in an inappropriate position), device migration of a component (device moving to another part of the body), problems with urination

Be sure to talk with your doctor so that you thoroughly understand all of the risks and benefits associated with the use of the device.

Axonics SNM Therapy for urinary control is indicated for the treatment of the symptoms of overactive bladder, including urinary urge incontinence and significant symptoms of urgency-frequency alone or in combination, in patients who have failed or could not tolerate more conservative treatments. This therapy is not intended for use in patients who have difficulty urinating because of a urinary blockage like benign prostatic hypertrophy, cancer, or narrowing of the urethra. 

Axonics SNM Therapy is contraindicated for patients who have not demonstrated an appropriate response to test stimulation or patients who are unable to operate the Axonics SNM Systems.

With all medical procedures, there are risks associated with the procedure and the use of the device, including long-term implantation. The risks include but are not limited to: adverse change in voiding function (bowel and/or bladder), infection, pain or irritation at the implant site, lead or device migration, electrical shock, change in sensation or magnitude of stimulation which has been described as uncomfortable (jolting or shocking) by some patients, and heating or burns at the device site.

If one or more of these complications occur, you may need medical treatment or surgery. Be sure to talk with your doctor so that you thoroughly understand all of the risks and benefits associated with the use of the device.

Urethral Bulking Therapy is intended for the treatment of female urinary incontinence, or the involuntary loss of urine with movement or activity that puts pressure on the bladder, such as coughing or sneezing. Patients who have an infection of the bladder or urethra, active herpes outbreak, pelvic infection, or a history of damage to the urethral tissue may not be a candidate for this procedure.

With all medical procedures, there are risks associated with the procedure and the use of the device, including long-term implantation of the hydrogel. These risks include but are not limited to pain with urination, blood in the urine, urinary tract infection, or difficulty urinating immediately following the procedure. Long-term risks include difficulty urinating, abscess, scarring of the urethra, and urinary urgency.

Be sure to talk with your doctor so that you thoroughly understand all of the risks and benefits associated with the use of the device.

The GreenLight Laser System is intended for the treatment of benign prostatic hyperplasia (BPH).

With all medical procedures, there are risks associated with the procedure and the use of the device. The risks associated with the GreenLight Laser System included but are not limited to: Painful or frequent urination, urgent need to urinate, blood in the urine or semen, urinary tract infection, inability to urinate or completely empty the bladder, scarring and narrowing of the urethra, narrowing of the bladder neck (areas of the bladder that connects to the urethra), urinary incontinence, dry orgasm, erectile dysfunction, and severe infection.

Be sure to talk with your doctor so that you thoroughly understand all the risks and benefits associated with the use of the device.

The Rezum System is a treatment for men; intended to reduce prostate tissue and relieve urinary symptoms caused by an enlarged prostate, otherwise known as BPH (Benign Prostatic Hyperplasia).

With all medical procedures, there are risks associated with the procedure and the use of the device. The risks include but are not limited to painful or frequent urination, blood in the urine or semen, inability to urinate or completely empty the bladder, post-op discomfort, urinary tract infection (UTI), decrease in ejaculatory volume, and an urgent need to urinate.

During the healing phase following the procedure, urinary symptoms may continue or worsen, which may require the use of a catheter for several days.

Be sure to talk with your doctor so that you thoroughly understand all the risks and benefits associated with the use of the device.

SpaceOAR and SpaceOAR Vue Hydrogels are intended to reduce the amount of radiation that is delivered to the rectum during radiotherapy for prostate cancer by creating more space between the prostate and the rectum. The products maintain space for approximately 12 weeks and are absorbed and passed naturally by the body in about 6 months, but it may take longer to fully absorb. SpaceOAR and SpaceOAR Vue Hydrogels contain polyethylene glycol (PEG). SpaceOAR Vue contains iodine. The use of these products in patients who are sensitive or allergic to these materials has not been studied.

With all medical procedures, there are risks associated with the procedure and the use of the device, including long-term implantation. The risks include but are not limited to: Pain associated with injection, pain or discomfort from the hydrogel, site inflammation, infection (including abscess), inability to urinate, urgent need to urinate or pass stool, constipation, rectal muscle spasm, damage to lining of rectum, ulcers, fistula (a hole between rectum and bladder, urethra, or skin below the scrotum), perforation (hole in prostate, bladder, urethra, rectum), necrosis (dead tissue), allergic reaction (local reaction or more severe reaction, such as anaphylaxis), embolism (blood vessel blockage is possible and may happen outside of the pelvis, potentially impacting vital organs or legs), fainting (which may range from briefly losing consciousness to more serious symptoms where CPR might be needed), bleeding. Patients who have undergone previous pelvic radiation therapy may have an increased risk of fistula.

If one or more of these complications occur, you may need medical treatment or surgery. Be sure to talk with your doctor so that you thoroughly understand all of the risks and benefits associated with the use of the device.