References
Titan® and Titan® Touch Inflatable Penile Prosthesis Brief Statement
Indications The Titan and Titan Touch Inflatable Penile Prosthesis is indicated for male patients suffering from erectile dysfunction (impotence) who are considered to be candidates for implantation of a penile prosthesis.
Contraindications The Titan, and Titan Touch Inflatable Penile Prosthesis is contraindicated in patients who have one or more of the following: Patients with an active infection present anywhere in the body, especially urinary tract or genital infection. Patients with a documented sensitivity to silicone. 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
Implantation of the device may make latent natural erections, as well as other interventional treatment options, impossible. Men with diabetes or spinal cord injuries, as well as immunocompromised patients, may have an increased risk of infection associated with a prosthesis. Failure to evaluate and promptly treat erosion may result in a substantial worsening of the condition, leading to infection and loss of tissue. Implantation of a penile prosthesis may result in penile shortening, curvature or scarring. Pre-existing abdominal or penile scarring or contracture may make surgical implantation more complicated or impractical.
Precautions
Surgeons implanting penile prostheses should be familiar with the currently available techniques for measuring the patient, determining implant size, and performing the surgery. Removal of an implanted prosthesis without timely reimplantation of a new prosthesis may complicate subsequent reimplantation or may make it impossible. A thorough preoperative consultation should include a discussion between the patient and physician of all available treatment options and their risks and benefits. The prosthesis should not be implanted in patients who lack the manual dexterity or strength necessary to operate the device. The device may be used in the presence of Peyronie’s Disease. If the manual modeling technique is to be utilized, see the Surgical Protocol for more information.
Potential Complications
Scrotal swelling, auto-inflation, discomfort, angulation/curvature, edema, device malfunction, chronic pain, difficulty with ejaculation, transient urinary retention, fever, migration, patient dissatisfaction, site infection, deflation, hematoma/seroma, wound leakage, bleeding, delayed wound healing, phimosis, sensory loss, cylinder aneurysm, fibrous capsule formation, over/under inflation, erosion, scrotal erythema, genital change, wound infection, and inguinal hernia.
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.
Virtue® Male Sling System Brief Statement
Indications The Coloplast Virtue Male Sling System is an implantable, suburethral support sling indicated for the treatment of male stress urinary incontinence (SUI).
Contraindications It is the responsibility of the surgeon to advise the prospective patients or their representatives, prior to surgery, of the contraindications associated with the use of this product. This product is contraindicated for patients with urinary tract infections or urinary tract obstruction; blood coagulation disorders or prescribed anticoagulation therapy; obstructive uropathy; or, are under the age of 18.
Warnings and Precautions
It is the responsibility of the surgeon to advise the prospective patients or their representatives, prior to surgery, of the possible warnings associated with the use of this product.
Potential Complications
As with all foreign bodies, the Virtue sling system is likely to exacerbate any existing infection. Transitory local irritation at the wound site and a foreign body response may occur. The resulting response could lead to wound dehiscence, extrusion, erosion, inflammation or fistula formation.
The following complications are known to occur with synthetic slings:
- urethral erosion
- infection
- bladder, urethra, vessel and nerve perforation
Known risks of incontinence surgical procedures include extrusion, erosion, infection, sling migration, pain, transient or permanent retention, bladder outlet obstruction, and, continued stress urinary incontinence and persistent or new overactive bladder symptoms.
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.
Genesis Malleable Penile Prosthesis Brief Statement
Intended Purpose The Genesis Malleable Penile Prosthesis is a flexible silicone elastomer device designed to be implanted into the penis for the management of erectile dysfunction (commonly known as impotence).
Indications The Genesis Malleable Penile Prosthesis (Prosthesis) is designed for the management of erectile dysfunction (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
The Genesis Malleable 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, patients with unresolved urinary problems such as an elevated residual urine volume secondary to bladder outlet obstruction or neurogenic bladder.
Warnings
It is the responsibility of the physician to advise the prospective patient prior to surgery, of the warnings and precautions associated with the use of this product and the associated surgical risks. The Genesis Malleable Penile Prosthesis should only be implanted by physicians experienced in the surgical procedures and techniques involving implantation of a malleable penile Prosthesis. The physician should maintain adequate education to conduct this procedure. Implantation of a penile Prosthesis may make natural erections difficult to achieve. It may make some other interventional treatment options not possible. Implantation of a penile Prosthesis may result in penile shortening, curvature or scarring. Pre-existing penile scarring or contracture may make surgical implantation more complicated or impractical. Failure to evaluate and promptly treat erosion may result in infection and loss of tissue. Men with diabetes as well as immunocompromised patients, may have an increased risk of infection which could result in permanent damage to tissue/organs. The Prosthesis should be used with caution in patients with borderline bladder decompensation, an indwelling catheter, or enlargement of the prostate.
Precautions
A thorough preoperative consultation should include a discussion between the patient and physician of other available treatment options and their risks and benefits. Patients should be informed that erections achieved with a malleable penile Prosthesis may differ from original erection (e.g. not of equal length or girth) compared to what was previously experienced with natural erections. Removal of an implanted Prosthesis without timely reimplantation of a new Prosthesis may make subsequent reimplantation more difficult.
Adverse Reactions
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 Reactions include: deformity, delayed/Impaired/Abnormal wound healing, erosion/extrusion, fistula, foreign body reaction, hematoma/Seroma, hemorrhage/bleeding, hypersensitivity/allergic reaction, infection (local or systemic), inflammation (i.e., edema, erythema), irritation, migration, necrosis, pain/discomfort, paraphimosis/acquired phimosis, perforation or injury of soft tissue (e.g., muscles, nerves, vessels), penile structures, or organs (e.g., urethra), scar tissue, sexual dysfunction, tactile disorders (e.g., hypoesthesia, numbness), urethral obstruction/occlusion, urinary tract infection, and 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.
Torosa® Saline-Filled Testicular Prosthesis Brief Statement
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
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 or hemorrhage 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.
Precautions
Each prosthesis should be checked for patency prior to surgery and continuously monitored throughout the surgical procedure to ensure that the structural integrity of the implant is not compromised in any way.
The action of drugs (such as antimicrobials, chemotherapy agents or steroids) in contact with the prosthesis has not been tested by the manufacturer, and their use cannot be recommended. Each physician who chooses to use drugs in combination with this prosthesis must assure compatibility of the drug with silicone elastomer.
A thorough preoperative consultation should include a discussion between the patient and physician of all available treatment options and their risks and benefits.
Implantation of the TOROSA Saline-Filled Testicular Prosthesis 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).
Potential Complications
Potential complications include pain and discomfort. 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 this 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.
