Products with tag 'Erectile Dysfunction'

Most patient types excluding extra-wide penile diameter.

Extra-wide penile diameter only.

One-piece manually operated device with Large, Medium and Standard cylinder sizing options. 3 Sizes high tension 'Ultra' Rings, 3 Sizes medium tension super-comfort 'Ultimate Surefit' rings, 3 Sizes low tension 'Select' Rings, 4 Sizes low tension easy removal 'SureEase' practice rings, 2 cushioned inserts, Ultra-Ease Ring loading System, 2 Sizes 'SureRelease' rings, lubricant, instruction DVD and guide-book (Erectile Dysfunction). Travel bag, one year warranty when purchased privately. 100% refund option within 90 days.

All patient types excluding extra-wide penile diameter. Including large to narrow penile diameter, poor manual dexterity, severe venous leak and hypersensitivity to ring pressure.

Variations:

• SOMAcorrect Xtra (Manual Version)

Flexible Rod Technology™ (FRT)

Flexible Rod Technology™ (FRT) Flexible Rod Technology provides easy bending and avoids undesirable turning on axis of the implant when erection desired by the patient.

Flexible Rod Technology™ helps the rod inside reach more than 135 degrees in each bending that provides natural erection feeling.

Indications

The device is indicated for implantation into the corpora cavernosa of the penis in men who are diagnosed as having erectile dysfunction. The malleable penile prosthesis is implanted to provide adequate penile rigidity for sexual intercourse.

It is designed for the treatment of organic, erectile dysfunction (impotence) of men due to:

• Pelvic fracture

• Spinal cord injury or disease

• Prostatectomy

• Multiple sclerosis

• Diabetes mellitus,

• Arteriosclerosis and hypertensive vascular disease,

• Priapism

• Peyronie’s disease

• Selectively for psychogenic impotence

Contraindications

It is contraindicated for the patients:

• The implantation of this device is contraindicated in patients who have active urogenital infections or active skin infections in the region of the surgery.

• Whose total corporal length is less than the cylinder size.

• Sensitive to silicone materials

• Patients with neurogenic bladder and/or urinary obstruction

• Patients who are elected by the urologist as inadequate mentally or physiologically and having silicone material allergy for operation cannot be operated because of contraindications states.

• Implantation of the malleable penile prosthesis is contraindicated in patients who require repeated urethral endoscopic protocols.

• Patients who wish to retain the probability of latent, natural or spontaneous erectile ability or other interventional therapy options cannot be operated by urologist because of contraindications states.

• The implantation of the malleable penile prosthesis is contraindicated with a malleable penile prosthesis for patients who have compromised tissue and cannot resist the permanent pressure.

Warnings

• The malleable penile prosthesis is designed to be implanted as a pair of matched cylinders. A single implanted cylinder may not be adequate to achieve sexual intercourse and may have an adverse effect on the reliability of the device.

• Known and potential complications include, but are not limited to, infection, erosion, migration, extrusion, mechanical malfunction, patient dissatisfaction, adverse tissue reaction, allergic reaction, prolonged or intractable pain, urinary obstruction, silicone particle migration, And other complications: O post-operative bleeding, hematoma, penile edema, penile necrosis/gangrene, perforation of the corpora or the urethra, inability to adequately dilate the corpora, incorrect sizing of the implant, and tearing or ripping of the device during or after implantation.

Precautions

Surgery Related

• Direct contact of surgical instruments to the malleable penile prosthesis may result in damage, rendering it unsuitable for implantation.

• During insertion, do not over bend cylinders beyond their natural U-shape as it may damage the malleable penile prosthesis and shorten its product life.

• Do not trim the distal or proximal ends of the cylinders, or the rear tip extenders. Trimming will damage the device.

• Careful intraoperative sizing is required to ensure proper device operation and to minimize the occurrence of sizing related complications such as migration and/or extrusion.

Device Related

• Implantation of a malleable penile prosthesis that has been in previous contact with or contaminated by body tissue or fluid, regardless of intervening, cleaning, or sterilization, is prohibited.

• The device is presented in a double pouch package and inside a protective carton box. The package should be checked in terms of damaging, tearing and puncture. Do not use the damaged, teared and punctured packages.

• Before unpacking, the expiry date of the product should be checked. Do not use the products which have passed the expiration date. Sterilization of the products which have passed the expiration date is not being guaranteed.

• Products which are removed from patients should be disposed as medical waste within the framework of legal procedures.

Patient Related

• Before operation, the urologist should decide and evaluate whether the patient is available for treatment of erectile dysfunction or not.

• A thorough preoperative consultation should include a discussion between patient and physician of all available treatment options and their risks and benefits.

• Sufficient patient skill and strength are required for the appropriate device position.

• Uncircumcised patients may have an increased risk of postoperative complications with the sub-coronal approach. Surgeons may wish to discuss performing a circumcision to reduce the risks of post-operative complications associated with this approach.

• Some malleable penile prosthesis operations can be complex or unpractical for patients who have penile scarring or contractor.

• Some adverse events can be occurred like urethral bleeding, pain, phimosis not high several, hematoma after operation.

• If the patient had been done revision surgery, they can live differences such length, flaccidity, sensation and girth associated with using new malleable penile prosthesis.

• Physiology and psychology states can hinder the successful operation of the device.

Indications

The device is indicated for those patients who had suffered from testicular agenesis, or when the testicle has been removed through surgery due to several pathologies and also designed for replacement. Saline-Filled Testicular Prosthesis is carried out for patients who had been removed testicles and, had been lost testicle because of different causes. These causes are:

– Ectopic testicle,
– Genitourinary cancer / Metastatic prostate cancer,
– Testicular bulk/tumor,
– Testicular torsion,
– Testicular atrophy,
– Testicular agenesis (unilateral or bilateral congenital absence of the testicles),
– Orchitis,
– Trauma, disease or other abnormalities,
– Transsexual surgery,
– Others (psychologically suitable patient)

Contraindications

The implantation of this prosthesis is contraindicated in patients who have active urogenital infections or active skin infections in the region of the surgery. The use of Saline-Filled Testicular Prosthesis is also contra-indicated in patients who have one or more of the following conditions:

– Insufficient tissue,
– Existing local or metastatic carcinoma,
– Deficient vascularization of tissue in local area,
– Irradiated tissue (in selected patients),
– A history of sensitivity to silicone materials,
– Physiologically / psychologically,
– Unsuitable patient

Warnings

This prosthesis contains a silicone elastomer. The risks and benefits of implanting this prosthesis in patients with documented sensitivity to silicone should be carefully considered.

Patients who undergo surgical operations are liable to complications during and after the surgery. Surgeries associated with the use of Saline-Filled Testicular Prosthesis entail risks or potential complications. Thus, prior to surgery, physicians should inform patients about possible complications related to the use of this prosthesis.

This product has been designed for single use.

Saline-Filled Testicular Prosthesis in children are only recommended for cosmetic purposes.

Patients must be taught to distinguish the prosthesis from the natural testicle through self-examination.

Removal of the prosthesis is advisable in the case of surgical, physical or psychological problems.

Precautions

Migration of the prosthesis may occur if the prosthesis is not sutured in place.

Use of an oversized prosthesis for the existing scrotal pocket may result in necrosis and subsequent extrusion.

The implantation of this prosthesis should only be considered in patients whom the physician determines are adequate surgical candidates.

A thorough preoperative consultation should include a discussion between patient and physician of all available treatment options and their risks and benefits.

Careful patient selection is essential, as well as a thorough diagnostic study before the surgery.

The prosthesis must be checked prior to and during the surgery, so as to monitor the structural integrity of the implant.

The prosthesis should be handled carefully, avoiding pointed, toothed, or sharp instruments, as any nick or damage may be the cause of subsequent complications of the implant.

Dirt, fingerprints, talc or any other substances that can contaminate the surface of the prosthesis may be the cause of reactions to foreign objects.

Extreme preventive measures must be taken to avoid contamination.

Any hole or mark in the prosthesis is a possible cause of failure, since it may serve as a surface to keep materials that may cause reactions to foreign objects or infections in the patient.

The device is presented in a double pouch package and inside a protective carton box. The package should be checked in terms of damaging, tearing and puncture. Do not use the damaged, teared and punctured packages.

Before unpacking, the expiry date of the product should be checked. Do not use the products which have passed the expiration date. Sterilization of the products which have passed the expiration date is not being guaranteed.

Products which are removed from patients should be disposed as medical waste in accordance with hospital, administrative and/or local government policy.

Indications

The device is indicated for those patients who had suffered from testicular agenesis, or when the testicle has been removed through surgery due to several pathologies and also designed for replacement. Firm Testicular Prosthesis is carried out for patients who had been removed testicles and, had been lost testicle because of different causes. These causes are:

– Ectopic testicle,
– Genitourinary cancer / Metastatic prostate cancer,
– Testicular bulk/tumor,
– Testicular torsion,
– Testicular atrophy,
– Testicular agenesis (unilateral or bilateral congenital absence of the testicles),
– Orchitis,
– Trauma, disease or other abnormalities,
– Transsexual surgery,
– Others (psychologically suitable patient)

Contraindications

The implantation of this prosthesis is contraindicated in patients who have active urogenital infections or active skin infections in the region of the surgery. The use of firm testicular prosthesis is also contra-indicated in patients who have one or more of the following conditions:

– Insufficient tissue,
– Existing local or metastatic carcinoma,
– Deficient vascularization of tissue in local area,
– Irradiated tissue (in selected patients),
– A history of sensitivity to silicone materials,
– Physiologically / psychologically,
– Unsuitable patient

Warnings

This prosthesis contains a silicone elastomer. The risks and benefits of implanting this prosthesis in patients with documented sensitivity to silicone should be carefully considered.

Patients who undergo surgical operations are liable to complications during and after the surgery. Surgeries associated with the use of firm testicular prosthesis entail risks or potential complications. Thus, prior to surgery, physicians should inform patients about possible complications related to the use of this prosthesis.

This product has been designed for single use.

Firm testicular prosthesis in children are only recommended for cosmetic purposes.

Patients must be taught to distinguish the prosthesis from the natural testicle through self-examination.

Removal of the prosthesis is advisable in the case of surgical, physical or psychological problems.

Precautions

Migration of the prosthesis may occur if the prosthesis is not sutured in place.

Use of an oversized prosthesis for the existing scrotal pocket may result in necrosis and subsequent extrusion.

The implantation of this prosthesis should only be considered in patients whom the physician determines are adequate surgical candidates.

A thorough preoperative consultation should include a discussion between patient and physician of all available treatment options and their risks and benefits.

Careful patient selection is essential, as well as a thorough diagnostic study before the surgery.

The prosthesis must be checked prior to and during the surgery, so as to monitor the structural integrity of the implant.

The prosthesis should be handled carefully, avoiding pointed, toothed, or sharp instruments, as any nick or damage may be the cause of subsequent complications of the implant.

Dirt, fingerprints, talc or any other substances that can contaminate the surface of the prosthesis may be the cause of reactions to foreign objects.

Extreme preventive measures must be taken to avoid contamination.

Any hole or mark in the prosthesis is a possible cause of failure, since it may serve as a surface to keep materials that may cause reactions to foreign objects or infections in the patient.

The device is presented in a double pouch package and inside a protective carton box. The package should be checked in terms of damaging, tearing and puncture. Do not use the damaged, teared and punctured packages.

Before unpacking, the expiry date of the product should be checked. Do not use the products which have passed the expiration date. Sterilization of the products which have passed the expiration date is not being guaranteed.

Products which are removed from patients should be disposed as medical waste in accordance with hospital, administrative and/or local government policy.

Rigicon® offers the Infla10® Inflatable Penile Prosthesis (IPP) for men that need surgical intervention for the management of Erectile Dysfunction. Infla10® is indicated for patients suffering from chronic, organic erectile dysfunction (impotence) and are candidates for a penile prosthesis implantation. Refer to Infla10® three-piece Inflatable Penile Prosthesis Instructions for Use for more detailed information.