Rigi10™ Malleable Penile Prosthesis
Detailed Answer
A penile prosthesis is a highly effective treatment option for erectile dysfunction (ED) that has not responded to other therapies. While it offers excellent satisfaction rates, there are several potential downsides that patients should be aware of before proceeding with implantation.
The primary disadvantages of penile prostheses include:
Invasive Surgical Procedure: Implantation requires surgery with associated risks of infection, bleeding, and anesthesia complications. According to the 2024-2025 EAU Guidelines, infection rates range from 1-3% for primary implants and can increase to 7-18% for revision surgeries [1].
Mechanical Failure: Device malfunction can occur over time. The 2024-2025 EAU Guidelines report 5-year mechanical reliability rates of 85-93% for inflatable prostheses [2]. When failure occurs, additional surgery is required for replacement.
Irreversibility: The implantation procedure permanently alters penile tissue structure. The cavernous tissue is deliberately damaged during implantation, making it extremely difficult to return to natural erections if the device is removed [3].
Altered Sensation: Some men report changes in penile sensation following implantation. The EAU Guidelines acknowledge that while overall satisfaction rates are high (92-100%), changes in sensation can occur [4].
Shortened Penis Length: Penile shortening is a recognized complication. The 2024-2025 EAU Guidelines note that perceived or actual penile shortening is a common complaint following implantation [5].
Cost: The procedure is expensive, with significant costs for the device, surgical procedure, and hospitalization. Insurance coverage varies widely.
Need for Device Operation: Inflatable prostheses require manual activation and deactivation, which some patients may find inconvenient or unnatural.
Revision Surgery: The potential need for revision surgery due to complications or device failure must be considered. According to the EAU Guidelines, revision rates can be significant, particularly for mechanical issues [6].
From the Guidelines
The 2024-2025 European Association of Urology (EAU) Guidelines on Sexual and Reproductive Health provide comprehensive information on penile prostheses: "Penile prosthesis implantation is typically reserved for patients who fail or cannot tolerate other forms of treatment, or who desire a permanent solution. Proper counseling of patients is essential to establish realistic expectations regarding post-operative outcomes" [7]. The guidelines emphasize that while penile prostheses provide the highest satisfaction rates among ED treatments (92-100%), patients must be fully informed about potential complications [8]. Regarding complications, the EAU Guidelines state: "The two main complications of penile prosthesis implantation are mechanical failure and infection. The 5-year mechanical reliability rates reported for inflatable prostheses range from 85-93%. Infection rates are typically 1-3% for primary implants and can increase to 7-18% for revision surgeries" [9]. The guidelines also note that "perceived or actual penile shortening is a common complaint" and that "careful patient selection, counseling, and surgical technique are essential to minimize complications and maximize patient satisfaction" [10].