Patient Information & Informed Consent
Rigicon® RIGI10™ and Shah Indian Malleable Penile Prosthesis
Understanding Erectile Dysfunction (ED)
Erectile dysfunction (ED) is the inability to achieve or maintain an erection that is firm enough for satisfactory sexual intercourse. It may occur due to diabetes, high blood pressure, pelvic surgery (such as radical prostatectomy), spinal cord injury, Peyronie’s disease, trauma, or aging. When medications such as sildenafil (Viagra®), tadalafil, injections, or vacuum devices fail, a penile prosthesis offers a permanent and highly effective solution.
What is a Malleable Penile Prosthesis?
A malleable penile prosthesis consists of two bendable rods surgically implanted inside the erectile chambers (corpora cavernosa) of the penis. The rods provide sufficient rigidity for sexual intercourse while allowing the penis to be bent downward for concealment when not in use.
Unlike inflatable implants, a malleable prosthesis has no pump or fluid reservoir, making it mechanically simple and easy to use.
Available Options
Two commonly used malleable penile prostheses in India are:
Rigicon® RIGI10™
Shah Indian Penile Prosthesis
Both are designed to restore sexual function but differ in design, cost, and certain performance characteristics.
Rigicon® RIGI10™
The Rigicon RIGI10 is an internationally marketed malleable penile prosthesis designed with modern engineering features.
Advantages
• Excellent rigidity for intercourse
• Good bendability for concealment
• Multiple diameter options (9–14 mm) allow better anatomical matching.
• Flexible Rod Technology allows significant bending while maintaining rigidity during intercourse.
• Hydrophilic coating designed to absorb antibiotic solution before implantation, potentially reducing infection risk.
• Soft distal tips reduce the risk of pressure on the glans.
• Rear tip extenders permit customized sizing.
Published clinical data have demonstrated excellent short-term device survival with low revision and infection rates.
Possible Limitations
• More expensive than Indian implants.
• Like all implants, infection or mechanical failure may still occur, although uncommon.
• The penis remains semi-rigid at all times.
Shah Indian Penile Prosthesis
The Shah Penile Prosthesis is an Indian-designed malleable implant that has been widely used for many years.
Advantages
• Considerably less expensive.
• Simple design with long clinical experience in India.
• Easy surgical implantation.
• No hydraulic components.
• Good rigidity for satisfactory intercourse in appropriately selected patients.
Possible Limitations
• Fewer sizing options compared with newer international devices.
• Concealment may not be as convenient for some patients depending on body habitus and implant size.
• Some patients feel the implant is less flexible than newer designs, while others report satisfactory everyday comfort. Comparative evidence remains limited, and choice should be individualized with the surgeon.
Similarities Between Both Implants
Both implants:
• Permanently treat erectile dysfunction.
• Allow penetrative sexual intercourse.
• Do not increase sexual desire.
• Do not affect orgasm.
• Usually do not affect ejaculation if it was present before surgery.
• Do not increase penile length beyond your natural stretched penile length.
• Are completely hidden inside the body.
• Require surgery under anesthesia.
Who Should Consider a Penile Prosthesis?
You may be a suitable candidate if:
• Tablets and injections have failed.
• You have severe erectile dysfunction.
• You have Peyronie’s disease with erectile dysfunction.
• You have diabetes with medication-resistant ED.
• You have erectile dysfunction after prostate surgery.
• You understand that implantation is generally irreversible because the erectile tissue is permanently altered.
What Happens During Surgery?
The operation usually takes 45–90 minutes.
The surgeon makes a small incision, measures the penis internally, selects the appropriate implant size, inserts two prosthetic rods into the corpora cavernosa, and closes the incision.
A urinary catheter may be used temporarily.
Most patients stay in the hospital for one day, although this varies.
Recovery
Most patients:
• Walk on the day of surgery.
• Experience swelling and discomfort for several days.
• Resume desk work within one to two weeks.
• Resume sexual activity after approximately 4–6 weeks, following medical review.
Benefits of Surgery
• Reliable erections whenever desired.
• Very high patient and partner satisfaction in published studies.
• No need for ED medications.
• Simple operation of the implant.
• Permanent solution for severe erectile dysfunction.
Risks and Possible Complications
Although uncommon, complications may include:
• Infection
• Bleeding or hematoma
• Pain
• Wound healing problems
• Implant erosion
• Device malfunction
• Penile shortening (perceived or actual)
• Reduced penile sensation (rare)
• Persistent dissatisfaction despite technically successful surgery
If infection occurs, implant removal may become necessary.
Frequently Asked Questions
Will my penis become larger?
No. The implant restores rigidity rather than increasing penile size.
Will my partner know I have an implant?
Usually not. The implant is entirely internal.
Can I father children?
Yes, if you produce sperm and have not undergone sterilization. The implant itself does not cause infertility.
Will I still have orgasm?
Most men continue to experience orgasm if they could do so before surgery.
Is the operation permanent?
Yes. Once implanted, natural erectile function generally cannot be restored.
Choosing Between Rigicon RIGI10 and Shah Prosthesis
There is no single “best” implant for every patient.
Rigicon RIGI10 may be preferred when:
Greater sizing flexibility is desired.
Enhanced concealability is important.
The additional cost is acceptable.
The Shah prosthesis may be preferred when:
Cost is a major consideration.
A simple, time-tested malleable implant is appropriate.
The patient understands its design characteristics and is satisfied with its expected performance.
Your surgeon will recommend the most suitable implant based on your anatomy, expectations, medical condition, and financial considerations.
Patient Consent Statement
I understand that:
I have erectile dysfunction that has not responded satisfactorily to conservative treatment.
A penile prosthesis is a permanent surgical treatment.
I understand the differences between the Rigicon RIGI10 and the Shah Indian Penile Prosthesis.
No implant can guarantee increased penile size or complete satisfaction.
Complications including infection, erosion, pain, and implant failure may require additional surgery or removal of the prosthesis.
My surgeon has answered my questions, and I have had sufficient time to consider my options.
I voluntarily consent to penile prosthesis implantation.
Patient Name: _______________________
Signature: ___________________________
Date: _______________________________
Witness: ____________________________
Surgeon: ____________________________
