Shah Penile Prosthesis Consent

Informed Consent For Surgical Operation / Procedure

Procedure: Shah Penile Prosthesis

1. Patient Identification

I, ______________________________ (patient/next of kin/legal guardian), aged ____ years, in my full senses, voluntarily authorize and give my complete consent for performance of the following procedure(s)/operation(s)/treatment(s):

Procedure: _______________________________
Diagnosis: ________________________________
Major illness & comorbidities: ________________________________

2. Authorization for Procedure

I authorize Dr. __________________ to perform the above procedure, along with such assistants and associates as may be selected by him/her.

I understand that members of the surgical team, including residents or trainees under appropriate supervision, may perform parts of the procedure according to their training and competence.

3. Nature of Procedure

I have been informed that I have a condition of erectile dysfunction that has not responded adequately to, or is unsuitable for, non-surgical treatment options including oral medications, injection therapy, vacuum erection devices or other conservative measures.

I have been advised to undergo surgical implantation of a Shah penile prosthesis.

I understand that this involves placement of a pair of silicone rods into the erectile chambers (corpora cavernosa) of the penis through a surgical incision, performed under spinal/general anaesthesia, to allow me to achieve rigidity sufficient for sexual intercourse by manually positioning the penis.

4. Benefits and Indications

  • Restoration of erectile function for penetrative intercourse
  • High patient and partner satisfaction
  • Long-term treatment for medically refractory erectile dysfunction
  • May improve quality of life and sexual confidence

5. No Guarantee Clause

I understand that no guarantee has been given regarding restoration of sexual satisfaction or device longevity.

Mechanical failure, revision surgery or replacement may be required in the future.

6. Risks and Complications

I understand that penile prosthesis surgery, like any surgical procedure, carries risks.

These include, but are not limited to:

  • Infection of the implant, which may require partial or complete removal of the device
  • Mechanical failure, erosion or extrusion of the device requiring revision or removal surgery in the future
  • Persistent pain, or shortening/narrowing of the penis
  • Curvature, asymmetry or altered cosmetic appearance of the penis
  • Injury to the urethra, bladder or adjacent structures requiring additional repair
  • Bleeding, haematoma or need for blood transfusion
  • Altered or reduced penile/glans sensation
  • Inability to achieve a fully natural-appearing erection
  • The device does not increase penile length beyond the pre-operative stretched length
  • Anaesthesia-related risks, including cardiopulmonary complications
  • Need for further surgery, including device revision, replacement or removal
  • Persistent dissatisfaction with cosmetic or functional outcome despite a technically successful procedure
  • Rare risk of penile prosthesis-related mortality or major morbidity

I understand that this list is not exhaustive and that unforeseen complications may occur.

7. Postoperative Course

Hospital stay is usually 1–2 days.

A urinary catheter may be required temporarily.

Scrotal swelling and discomfort are expected.

Sexual activity should be avoided until cleared by the surgeon.

8. Alternatives to Procedure

  • Oral phosphodiesterase-5 inhibitor medications
  • Intracavernosal or intraurethral vasoactive injections
  • Vacuum erection devices
  • Inflatable (multi-component) or malleable penile prosthesis as an alternative surgical option
  • No treatment/observation
  • The relative benefits, risks and expected outcomes of these alternatives have been discussed with me, and I understand why a malleable prosthesis has been recommended in my case.

9. Blood Transfusion Consent

I consent to blood/blood product transfusion if required and understand the rare risks including infection and allergic reactions.

10. Anaesthesia and Pain Management

I understand the risks of general/regional anaesthesia and available pain management options.

11. Photography / Data Use

I consent to medical photography/video and anonymised use of my clinical information for academic/research purposes.

12. Intraoperative Decision Consent

I authorize the surgical team to modify or extend the procedure depending on intraoperative findings, including changing prosthesis type or abandoning implantation if unsafe.

13. Team-Based Care

I understand that qualified assistants/trainees may participate under appropriate supervision.

14. Patient Statement

I confirm that I have understood the procedure, risks, benefits and alternatives.

My questions have been answered, and I give consent voluntarily.

Patient/Attendant to write in own handwriting:

“I have understood the procedure, risks, benefits and alternatives explained to me in a language I understand.”

Signatures

Patient Name & Signature: ______________________________________

Date: ____________________ Time: ____________________

Doctor Name & Signature: ______________________________________

Date: ____________________ Time: ____________________

Witness Name & Signature: ____________________________________

Contact No.: ______________________________

ATTENDANT CONSENT (If applicable)

Reason patient unable to consent:

Attendant Name: __________________________________________

Relationship: _____________________________________________

Signature: ________________________________________________

Contact No.: ______________________________________________

INTERPRETER STATEMENT (If applicable)

I confirm an accurate explanation in understandable language.

Name: _________________________________________________

Signature: ______________________________________________

Contact: ________________________________________________

HIGH-RISK CONSENT (If applicable)

High-risk factors explained due to:

Patient Signature: ________________________________________

Doctor Signature: _________________________________________

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