Important safety information

Physicians pictured in social media posts are or may be paid consultants for Boston Scientific.

Caution: U.S. Federal law restricts this device to sale by or on the order of a physician.

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

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

Caution: U.S. Federal law restricts this device to sale by or on the order of a physician 

Your doctor is your best source for information on the risks and benefits of the AMS Ambicor™ Inflatable Penile Prosthesis. Talk to your doctor for a complete listing of risks, warnings and important safety information. 

The AMS Ambicor™ Inflatable Penile Prosthesis is intended for use in the treatment of male erectile dysfunction (impotence). 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 skin infections may have an increased risk of infection. Implantation may result in penile curvature or scarring. 

Potential risks may include: device malfunction/failure leading to additional surgery, device migration potentially leading to exposure through the tissue, wearing away/loss of tissue (device/tissue erosion) infection, unintended-inflation of the device and pain/soreness. MH-545613-AB

Caution: U.S. Federal law restricts this device to sale by or on the order of a physician

Your doctor is your best source for information on the risks and benefits of the Tactra™ Malleable Penile Prosthesis. Talk to your doctor for a complete listing of risks, warnings, and important safety information.

The Tactra™ Malleable Penile Prosthesis is intended for use in the treatment of erectile dysfunction (impotence) in adult males. Implanting a penile prosthesis will damage or destroy any remaining natural ability to have a spontaneous erection, as well as make other treatment options impossible.

Men with diabetes, spinal cord injuries, or skin infections may have an increased risk of infection. Implantation may result in penile shortening, curvature or scarring. 

Additional information is provided in Patient Literature, available through your doctor. MH-611821-AA