PM-17913
Titan and Titan Touch Inflatable Penile Prosthesis Brief Statement
Indications
The Titan Inflatable Penile Prosthesis is indicated for male patients with erectile dysfunction who are considered to be candidates for implantation of a penile prosthesis.
Contraindications
The Titan Inflatable Penile Prosthesis is contraindicated in patients who have one or more of the following conditions: Patients with an active infection present anywhere in the body, especially urinary tract or genital infection. Patients with a documented hypersensitivity or allergic reaction to silicone or polyurethane. Patients with unresolved problems affecting urination, such as an elevated residual urine volume secondary to bladder outlet obstruction or neurogenic bladder. Patients unwilling to undergo any further surgery for device revision.
Warnings
The Titan device should only be implanted by physicians experienced in the surgical procedures involving implantation of a penile prosthesis. Physicians should advise prospective patients, prior to surgery, of the warnings, precautions and potential complications associated with the use of this product, which may include the following: Potential for resurgery (Note: device is not a lifetime implant). Implantation makes latent natural erections, as well as other interventional treatment options, impossible. Implantation may result in penile shortening, curvature or scarring. Pre-existing abdominal or penile scarring or contracture may make surgical implantation more complicated or impractical. Diabetic, as well as immunocompromised patients, may have an increased risk of infection which could result in permanent damage to tissue/organs. Vigorous exercise and manual massage could lead to device damage. Certain stresses and pressures (straddle seating, obesity, etc.) could lead to involuntary inflation or deflation.
Precautions
Patients with spinal cord injury may have an increased risk of infection. This device may be used to treat ED in the presence of Peyronie’s disease. A thorough preoperative consultation should include a discussion between the patient and physician of available treatment options and their risks and benefits. Patient selection should consider the following factors which could lead to increased risk of failure and can be critical to the eventual success of the procedure: Ability and willingness of the patient to follow instructions. Associated psychological status (e.g. psychogenic erectile dysfunction, inappropriate attitude or motivation). Health conditions which hamper sexual activity, such as severe angina, may prevent successful use of this device. Manual dexterity problems.
Potential Complications
Adverse events are known to occur with penile protheses procedures and implants; some may require revision surgery or removal of the implant. Adverse events following penile protheses implantation may be de novo, persistent, worsening, transient, or permanent.
Adverse events may include but are not limited to: Acquired phimosis, Adhesion(s), Bladder storage symptoms, Capsular contracture, Deformity, Delayed/Impaired/Abnormal wound healing, Discomfort, Erosion/Extrusion, Fistula, Foreign body reaction, Hematoma/Seroma, Hemorrhage/Bleeding, Hernia, Hypersensitivity/Allergic reaction, Induration, Infection (local or systemic), Inflammation (including, but not limited to edema, erythema, redness, swelling), Male Dyspareunia, Necrosis, Obstruction/Occlusion, Pain, Perforation or injury of soft tissue (e.g., muscles, nerves, vessels), structures, or organs (e.g., bowel, bone, bladder, urethra, ureters), Scar tissue, Sexual dysfunction, Tactile disorders, e.g., hypoesthesia, numbness, Urinary incontinence symptoms, Urinary tract infection, Voiding symptoms.
The occurrence of these events may require one or more subsequent surgeries which may or may not always fully correct the complication.
The information provided is not comprehensive with regard to product risks. For a comprehensive listing of indications, contraindications, warnings, precautions, and adverse events refer to the product’s Instructions for Use. Alternatively, you may contact a Coloplast representative at 1-800-258-3476 and/or visit the company website at www.coloplast.com.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
PM-02124 / Feb 2024
Virtue® Male Sling System Brief Statement
Indications
The Virtue Male Sling System is an implantable, suburethral support sling indicated for the treatment of male stress urinary incontinence (SUI).
Contraindications
The Virtue Male Sling is contraindicated in patients with one or more of the following conditions: Documented hypersensitivity or allergic reaction to polypropylene. Active infection, including untreated urinary tract and/or infection in the operative field. Patients with untreated or serious blood coagulation disorders. Patients with obstructive uropathy. Patients under the age of 18.
Warnings
It is the responsibility of the physician to advise prospective patients prior to surgery, of the warnings associated with the use of this product and the associated surgical risks. The Virtue Male Sling should only be implanted by physicians experienced in the surgical procedures and techniques involving placement of stress urinary incontinence slings.
A thorough assessment of each patient should be conducted, based on current medical practice guidelines, to determine the suitability of a sling procedure. Patients should be counseled that the Virtue Male Sling is permanent.
It is recommended that sling candidates are evaluated for overactive bladder syndrome and post-void residual. Residual sphincteric function should be considered prior to sling surgery.
It is recommended that sling candidates are evaluated for the presence of bladder neck contracture or urethral strictures prior to sling surgery.
The patient should be counseled to consider conservative incontinence treatments as well as other treatments. Sling associated complications may result in one or more revision surgeries which may lead to partial or complete removal of the sling. Complete removal of the sling may not always be possible, and removal may not fully correct these complications. De novo complications may occur.
The additional risks versus benefits of Virtue Male Sling should be considered in patients with one or more of the following conditions:
auto-immune disease, coagulation disorder, connective tissue disease, debilitated or immunocompromised state, diabetes, pelvic radiation therapy, physical characteristics (e.g., body mass index), renal insufficiency, smoking related underlying conditions.
Potential Complications
Adverse events are known to occur with sling procedures and implants. Adverse events following sling implantation may be immediate or delayed, localized or systemic, de novo or worsening, acute or chronic, transient or permanent.
Adverse events may include but are not limited to: allergic reaction, hypersensitivity; autoinflammatory /autoimmunity syndrome; bladder storage symptoms (e.g., increased daytime frequency, urgency, nocturia, overactive bladder, urinary incontinence); bleeding/hemorrhage or hematoma, delayed/impaired/abnormal wound healing; exposure, extrusion or erosion of sling into other structures or organs; fistula formation; foreign body granuloma/scar tissue formation; genital paresthesia; infection; inflammation/irritation; male dyspareunia; necrosis; neuromuscular disorder; palpable mesh; pain; perforation or injury to adjacent muscles, nerves, vessels, structures, or organs (e.g., bone, bladder, urethra, ureters, bowel); seroma; sexual dysfunction; sling migration; urinary tract infection, urinary tract obstruction; voiding symptoms (e.g., dysuria, urinary retention, incomplete emptying, bladder outlet obstruction, straining, position-dependent voiding, slow stream).
The information provided is not comprehensive with regard to product risks. For a comprehensive listing of indications, contraindications, warnings, precautions, and adverse events refer to the product’s Instructions for Use. Alternatively, you may contact a Coloplast representative at 1-800-258-3476 and/or visit the company website at www.coloplast.com.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
PM-02084 / Apr 2024
Genesis® Malleable Penile Prosthesis Brief Statement
Indications
The Prosthesis is designed for the management of impotence stemming from a variety of causes, including: epispadias; pelvic fracture; spinal cord injury or disease; prostatectomy; cystectomy; abdominal-perineal resection; multiple sclerosis; diabetes mellitus; alcoholism; arteriosclerosis and hypertensive vascular disease; priapism; and Peyronie’s disease. The Prosthesis may also be used in selected patients with psychogenic impotence.
Contraindications
Implantation procedures are not advisable if infection is present anywhere in the body, especially urinary tract or genital infection.
The Prosthesis should not be used in patients who have unresolved problems such as elevated residual urine from bladder outlet obstruction, or neurogenic bladder.
The Prosthesis should be used with caution in diabetic patients who are more susceptible to infection and the complications of infection than nondiabetic patients.
Other contraindications include unresolved urinary problems, any condition which may hamper sexual activity (such as severe angina), a history of sensitivity to foreign materials, compromised wound healing, compromised immune system, any anatomic or physiologic abnormality that could lead to significant postoperative complications, an unwillingness to undergo any further surgery for revision and psychological instability of the patient.
Warnings
Coloplast relies on the surgeon to advise the patient of all potential risks and complications associated with the proposed surgical procedure and device, including providing a comparison of the risks and complications of alternative procedures and implants. Patients should be advised that penile implants should not be considered lifetime implants due to the inherent nature of silicone implants, implant procedures and potential individual physiological reactions.
Any surgeon implanting the Prosthesis should be familiar with the currently available techniques for measuring the patient, determining the implant size, and performing the surgery.
The Prosthesis should be used with caution in patients with borderline bladder decompensation or enlargement of the prostate.
Spontaneous urethral extrusion of the Prosthesis has occurred in paraplegics with indwelling catheters at the time of operation; therefore, patients should be free of catheters prior to implantation.
Precautions
The patient should undergo a thorough diagnostic evaluation and psychiatric/sexual counseling may be considered. Patent corpora cavernosa are prerequisite for the insertion of the Prosthesis.
Potential Complications
Complications may include, but are not limited to, the following: • Foreign body response, • erosion, • perforation or extrusion, • infection, • necrosis, • device malfunction (e.g., twisting, fracture, separation), • impaired blood flow to penis, • lymphedema of the penis, • hematoma, • scarring, • pain, • malposition, • SST deformity, • incorrect sizing, • paraphimosis, • voiding difficulty, • decreased sensation, and • inflammation/irritation.
Advice to Patient
Prosthesis may differ from original erection (e.g. not of equal length or girth) compared to what was previously experienced with natural erections.
The information provided is not comprehensive with regard to product risks. For a comprehensive listing of indications, contraindications, warnings, precautions, and adverse events refer to the product’s Instructions for Use. Alternatively, you may contact a Coloplast representative at 1-800-258-3476 and/or visit the company website at www.coloplast.com.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
PM-16954 / Apr 2024
Torosa® Saline-Filled Testicular Prostheses Brief Statement
Indications
The Coloplast Torosa Saline-Filled Testicular Prosthesis is intended for use when cosmetic testicular replacement is indicated i.e., in the case of agenesis or following the surgical removal of a testicle.
Contraindications
The implantation of testicular prostheses is contraindicated in the presence of infection or untreated neoplasm.
Warnings
Implantation of a testicular prosthesis in patients with pre-existing varicoceles may result in persistent pain. Testicular implants should not be considered lifetime implants due to the inherent nature of silicone implants, implant procedures, and potential individual psychological reactions. This device contains solid silicone elastomer. The risks and benefits of implanting this device in patients with lupus (e.g., SLE or DLE), scleroderma (e.g., progressive systemic sclerosis), myasthenia gravis, or documented sensitivity to silicone should be carefully considered. The issue of the possible relationship between silicone and various diseases has been and continues to be the subject of scientific and medical debate. Sepsis, hemorrhage, thrombosis, or tissue necrosis may result from the placement of any foreign object in the body. Excessive fibrous capsular formation or contracture may occur around any implant placed in contact with soft tissues. The incidence and severity of this occurrence may increase if postoperative local hematoma or infection occurs.
Precautions
Implantation of the device may be difficult or impossible in patients with inadequate scrotal tissue to cover the prosthesis, patients who have undergone prior pelvic radiation therapy, or patients whose wound healing abilities are compromised (e.g., uncontrolled diabetes, poor circulation). Pre-existing infection should be treated and resolved before implantation of the prosthesis. These devices must only be used by surgically trained and experienced physicians. Saline-filled implants may leak over time and long-term results cannot be guaranteed. A thorough preoperative consultation should include a discussion between the patient and physician of all available treatment options and their risks and benefits.
Potential Complications
The following device and procedure-related adverse events were reported during the pivotal clinical trial: pain, discomfort, edema, extrusion, displacement/migration, genitalia hematoma, keloid formation, implant deflation, fluid accumulation (inguinal area), constipation, fibrosis, granuloma, mobile implant, neuropathy (leg), numbness (heel), and suture abscess.
Advice to Patient
Patients should be advised that testicular implants should not be considered lifetime implants due to the inherent nature of silicone implants, implant procedures and potential physiological reactions. It is the physician’s responsibility to advise the patient of all potential complications and risks associated with the use of testicular implants.
The information provided is not comprehensive with regard to product risks. For a comprehensive listing of indications, contraindications, warnings, precautions, and adverse events refer to the product’s Instructions for Use. Alternatively, you may contact a Coloplast representative at 1-800-258-3476 and/or visit the company website at www.coloplast.com.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
PM-02203
