TUBE Malleable penile prosthesis - instructions for use & patient guide (Promedon)

INSTRUCTIONS FOR USE

Description

The TUBE penile prosthesis has been designed to be implanted into the penis for the management of impotence. It serves as stiffener that helps a patient suffering from erectile impotence th achieve vaginal pemetration (intercourse). It is inserted into the corpora cavernosa through surgery.

The TUBE penile prosthesis consists of two hemiprosthesis. The twisted and welded silver wires placed in the nuclei are surrounded by a teflon tube which contains a medical grade silicone elastomer cover.

Each hemiprosthesis is implanted in each corpus cavernosum. The TUBE penile prosthesis available in different diameters. The final length of the implant can be adapted by means of its trimmable extreme as well as by the rear tips. For vaginal penetration (intercourse) the prosthesis should be placed in erected position by hand. However, it is alsso possible to place the penis in relaxed position, due to excellent placing memory that is given by the implant nucleous.

Presentation

Order number and dimansions
Oder number	Trimmable length (mm)	Functional length (mm)	Diameter (mm)
T-090 T-100 T-110 T-120    T-120VS T-130    T-130VS	65 65 70 80 60 80 80	135 155 170 180 155 187 172	9 10 11 12 12 13  13
Each set includes 2 rearof 10 mm and 15 mm. *The functional length is measured without considering the length of the rear tips.  Sterilization method: Ethylene Oxide.

Indications

Designed for implantation into the penis, TUBE malleable penile prosthesis is advisable for all those patients who suffer from erectile impotence and who are considered candidates for surgical implants.

The TUBE penile presthesis has been used for treatment of erectile impotence derived form various causes: spinal cord injuries, post-surgical lesions, multiple sclerosis, arteriosclerosis, arterial hypertension, and others. The prosthesis can also be used in selected patients with psychogenic impotence.

Contraindications

The prosthesis implant is not recommended if there is infection in some parts of the body, particularly if it is genital or in the urinary tract.

TUBE malleable penile prosthesis cannot be used in patients with urological problems, such as urethral obstruction, urine residues, etc.

TUBE malleable prosthesis must be used with caution in patients with diabetes.

Warnings

The prosthesis must be implanted in both corpora cavernosa. Only one hemiprosthesis will provide insufficient stiffness for satisfactory use, and it can even impede vaginal penetration (intercourse)

Each hemiprosthesis must be checked before and during implant. A damaged prosthesis must mot be used for implant.

The prostheses should mot be handled with pointed, toothed, or sharp cornered instruments, as any nick can be the focus for subsequent failure of the implant. Care should be taken even in manipulating the prosthesis with blunt instruments, to avoid deformations, damage or other problems.

Dirt, fingerprints, talc or other contaminants can be the cause of foreign body reactions. Serious preventive measures must be taken to avoid contamination.

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

Prosthesis excessive length may result in voiding difficulties, inflammation, pressure necrosis, and erosion into the urethra or through the tunica albuginea of the corpus cavernosum.

Extreme care should be taken in the dilation of the corpus cavernosum to avoid penetration or over-stertching of the corpus wall and the urethra.

The malleable prosthesis produces an increase in the urethral resistance.

Therefore, it should be used caution in patients with borderline bladder decompensation or enlargement of the prostate, since T.U.R will be impossible with implanted prosthesis.

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

The implant or damage or destroy toe natural or spontaneous erectile capacity, latent or in existence.

This product has been designed for dingle use. Therefore, DO NOT REUSE or RESTERILIZE them, as this can potentially result in compromised device performance and increased of imappropriate and cross contamination.

Patient information

The patient must know that erections produced with the penis implant will not be like the previous experiences with normal erections.

It is the surgeon's responsibility to inform the patient and/or his representatives, before surgery, about all possible complications related to prosthesis implantation.

Promedon and its distributors delegate to the surgeon the responsibility of informing the patient about all possible risks and advantages related to prosthesis implantation and usage.

Precautions

Careful patient selection is essential. Thorough diagnostic study should precede this operation.

The prosthesis is supplied sterile and pyrogen free in a double-warp packaging system. This packaging is contained into a cardboard box wrapped with a thermocontrible foil which must be undamaged.

IF IT WAS DAMAGED WHEN HANDLING, THE PROSTHESIS SHOULD NOT BE IMPLANTED.

It is difficult to determine penile size preoperatively: therefore, all diameter prosthesis should be abailable for each case.

Operating Room Conditions: In general, operating rooms meet the requirements for penile or testicular implant surgery. Nevertheless, we strongly recommend checking the following parameters:

- Operating room asepsis.

- Adequate training for the surgical support personnel.

Magnetic resonance (MR) enviorment

Non-clinical testing performed in the worst-case product has demonstrated that tube malleable penile prosthesis implants are MR conditional. A patient with these devices can be safely scanned in an MR system meeting the following conditions.

- Static magnetic fienf of 1.5 tesla and 3 tesla, with

- Maximum force product of 231 T2/m

- Theoretically estimated maximum whole body averaged (WBA) specific absorption rate (SAR) of 2 W/kg (Normal operating mode)

Under the scan conditions defined above, the tube malleable penile prosthesis implants are expected to produce a maximum tenperature rise of less than 1.5℃ (2W/kg, 1.5 Tesla) RF-related temperature increase with a background temperature increase if ~ 1.3℃ (2 W/kg 1.5 Tesla) 0.6℃ (2 W/kg, 3 Tesla) RF-related temperature increase with a background temperature increase of ~ 0.6℃( 2 W/kg, 3 Tesla) after 15 minutes of continuous scanning

In non-clinical testing, the image artifact caused by device extends approximately 3.74mm from the Tube malleable penile prosthesis implants when imaged with a spin echo pulse sequence and a 3 Tesla MR system.

Complications

Possible complications associated with use of this prosthesis must be discussed with the patient prior to surgery.

Complications which may result from the use of this prosthesis include the risks associated with the medication and methods utilized in the surgical proscedure, as well as the patient's degree of intolerance to any foreign object implanted in the body. Some complications may demand prosthesis removal. Infections that do not respond to therapy with antibiotics demand prosthesis removal.

Some patients may feel pain in the gland or the scrotum immediately after surgery.

Reported cimplications of penile prosthesis include:

- Eresion, preforation or extrusion of the implant through the corona glandis, corpus cavernosum and urethra.

- Wound infection, including secondary necrosis and extrusion of the implant. Serious infection cannot be resolved in the presence of the prosthesis.

- Mild to severe lymphedema of the penis.

- Penile or perneal hematoma.

- Malposition of the prosthesis

- Paraphimosis

- Mechanical failure of the implant due to fracture or separation of the component parts.

Other complicatoins include difficulty in voiding, decreased penile sensation, and irritation of the corona glandis.

Surgeons are requested to notify Promedon S.A. or Promedon's distridutor of any complications encountered with the use of this prosthesis.

Surgical approach

The characteristics of TUBE prosthesis allow any of the usual surgical approaches techniques:

- Distal or subcoronal Technique.

- Perineal Approach.

- Pene-scrotal Approach.

The bibliography mentioned bellow could help surgeons to get acquainted with the techniques.

Copies of surgical protocols are available from promedon and should be reviewed prior to surgery.

References

- Furlow WL. Surgery for Male Impotence, Chapter 83 In Urologic Surgery, edited by JF Glenn. J.B. Lippincott company, Philadelphia, 837-851, 1983.

- Fallon B and Narayana AS. Surgery of the Penis. edited by Culp DA, Fallon B and Loening SAH. Year Book Medical Publishers, Chicago, 470-473 1985.

PATIENT GUIDE

Description

The TUBE penile prosthesis has been designed to be implanted into the penis for the management of impotence. It serves as a stiffener that helps a patient suffering from erectile impotence to achieve vaginal penetration (intercourse). It is inserted into toe corpora cavernosa through surgery.

The TUBE penile prosthesis consists of two gemiprosthesis.

The twisted and welded silver wires placed in the nucleuses are surrounded by a teflon which TUBE contains a medical grade silicons eslastomer cover.

For vaginal penetration (intercourse) the prosthesis should be placed in erect position by hand. However, it is also possible to place the penis in relaxed position, due to its excellent placing memory that is given by the implant nucleous.

Prosthesis use

Most patients are able to use their prosthesis six to eight weeks after their surgery. But some patients require a little more time. It depends upon your health and how fast you heal. Check with your doctor before first using your prosthesis or for any question you have about it. It should bend easily into the erect position or down for concealment.

Here are some tips to follow:

- It is recommended that partners become involved with the patient's recovery and his new prosthesis. Some time is needed to adjust to the prosthesis in the physical relationship.

- If you could ejaculate and achieve orgasm before surgery, you should be able to do so afterward. If they were not possible due to a physical or organic condition, the implant probably will not restore these abilities.

- Prosthesis use should not cause.

discomfort your partmer. You may feel some apprehension or even mild discomfort for a while. Lubrication may relieve the discomfort that couples might ecperience, who have not had sexual intercourse for some time.

- No especial care is needed for an implant. AVOID the following conditions that could occur during some recreational or sexual activies: repeatedly bending a prothesis up and down, subjecting the prosthesis to repeated vibrations or being hit by a strong blow to the groin. An implant exposed to these conditions could lose its rigidity or break.

Magnetic Resonmance(MR) enviorment

Non-clinical testing performed in the worst0 case product has demonstrated that Tube Malleable Penile prosthesis implants are MR conditional. A patient with these devices can be safely scanned in an MR system meeting the following conditions:

- Static magnetic field 1.5 Tesla and 3 Tesla, With

- Maximum spatial field gradient of 12.800 G/cm (128 T/m)

- Maximum force product of 231 T2/m

- Theoretically estimated maximum whole body averaged (WBA) specific absorption rate (SAR) of 2 W/kg (Normal Operating Mode)

Under the scan conditions defined above, the Tube Malleable Penile prosthesis implants are expected to produce a maximum temperature rise of less than 1.5℃(2 W/kg, 1.5 Tesla) RF-related temperature increase with a background temperature increase of ~ 1.3℃ (2 W/kg, 1.5 Tesla) 0.6℃ (2 W/kg, 3 Tesla) RF-rated temperature increase with a background temperature increase of ~ 0.6℃ (2 W/kg, 3 Tesla) after 15 minutes of continuous scanning.

In non-clinical testing, the image artifact caused by the device extends approximately 3.74mm form the Tube Malleable Penile prosthesis implants when imaged with a spin echo pulse sequence and a 3 Tesla MR system.

Warning

The patient shound consult his physician if he:

- Has difficulties when urinating.

- Feels pai in the gland or the scrotum immediately after surgery.

- Sees that the prosthesis finds it difficult to keep penis either in erect or down positions.

- Feels discomfort, throbbing of heart or prosthesis movement.