Important safety information

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

The AMS 800 AUS is used to treat urinary incontinence due to reduced outlet resistance (intrinsic sphincter deficiency) following prostate surgery.

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)
• Any 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.

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 AdVance™ XP Male Sling System. Talk to your doctor for a complete listing of risks, warnings, and important safety information.

The AdVance™ XP Male Sling System is intended for the treatment of male stress urinary incontinence (SUI). Potential risks may include inability to urinate (urinary retention), return to incontinence, infection, erosion, device migration, pelvic organ dysfunction, bleeding, and pain. These devices are contraindicated for patients with urinary tract infections, blood coagulation disorders, a compromised immune system, or any other condition that would compromise healing, with renal insufficiency, and upper urinary tract relative obstruction.

Please consult your physician to discuss the associated risk and complications for the specific surgical material you receive.

The following adverse events and known risks have been reported due to suburethral (beneath the urethra) mesh sling placement, any of which may be ongoing, but are not limited to: Abscess (swollen area within the body tissue, containing a buildup of pus), Allergic reaction to the implant, Apareunia (inability to perform sexual intercourse), Bleeding from the vagina, Complete failure of the procedure/failure to resolve a patient’s stress urinary incontinence, Dehiscence of vaginal incision (opening of the incision after surgery), De novo detrusor instability (involuntary contraction of the bladder wall leading to an urge to urinate), Dyspareunia (pain during sexual intercourse), Edema and erythema at the surgical site (swelling and redness), Erosion into the following organs: urethra, bladder, or other surrounding tissues and exposure/extrusion into the vagina (when the mesh goes through the vagina into other organs or surrounding tissue), Fistula formation (a hole/passage that develops through the wall of the organs) that may be acute or chronic, Foreign body reaction (body’s response to the implant) that may be acute or chronic, Hematoma formation (bruising), Infection, Inflammation that may be acute or chronic (redness, heat, pain, or swelling at the surgical site as a result of the surgery), Irritation (redness or pain) at surgical site, Leg weakness (muscle weakness), Mesh contracture (mesh shrinkage), Pain or discomfort to the patient’s partner during intercourse, Pain/Ongoing Pain/Severe/Chronic Pain in the pelvis, vagina, groin/thigh, and suprapubic area that may be acute or chronic (pain or ongoing pain just above the pubic bone, pelvis, vagina, groin/thigh area that may be severe and could last for a long time), Pain with intercourse that may not resolve, Perforation or laceration of vessels, nerves, bladder, urethra or bowel (a hole in or damage to these or other tissues that may happen during placement), Scarring, scar contracture (tightening of the scar), Stone formation (as a result of mesh erosion/exposure/extrusion in the urethra or bladder where the mesh is exposed to urine, mineral deposits may form along the mesh, also known as stones), Tissue contracture (tightening of the tissue), Voiding dysfunction: incontinence, temporary or permanent lower urinary tract obstruction, difficulty urinating, pain with urination, overactive bladder, and retention (involuntary leakage of urine or reduced or complete inability to empty the bladder from the mesh being implanted too tightly beneath the urethra). The following additional adverse events have been reported for the Solyx SIS System: Dysuria (painful/difficult urination), Hematuria (blood in the urine). The occurrence of these events may require surgical intervention and possible removal of the entire mesh. In some instances, these events may be permanent after surgery or other treatments. Removal of mesh or correction of mesh-related complications may involve multiple surgeries. Complete removal of mesh may not be possible and additional surgeries may not always fully correct the complications.

Bulkamid Urethral Bulking System is indicated for the treatment of stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD) in adult women. The Cystoscope is indicated for endoscopic surgical procedures.  

 Bulkamid Urethral Bulking System must not be used in patients suffering from acute urinary tract infection. Consult your physician if you are suffering from other pelvic infections, pelvic trauma, or pelvic inflammatory disease.  

 Potential risks may include infection, inability or difficulty to urinate, painful urination, excreted bulking material, embolism, blood in the urine, frequent urination at night, urinary tract infection, intense sudden need to urinate, infection or irritation in the vagina/genital area, worsening urinary incontinence, abnormal blood lab results (Immunoglobulin E), back/neck pain, dizziness/fainting, pain, blockage of blood vessels by a clot, redness of the skin, inflammation, migration of injected Bulkamid material, and urethral erosion.  

 Patients suffering from blood coagulation disorders are at higher risk of complications including hematoma or urethral bleeding, as with any invasive procedure. If a patient has undergone major surgery or dental work, Bulkamid should not be injected until the patient has fully recovered. The effect of Bulkamid has not been evaluated in women during pregnancy, delivery or lactation. Patients should be counseled that one or more repeat Bulkamid Hydrogel injection procedures may be required.  

 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 urinary retention and 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. Axonics SNM Therapy for bowel control is indicated for the treatment of chronic fecal incontinence in patients who have failed or are not candidates for more conservative treatments.

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.