If you are considering a malleable penile implant in India, you will probably come across names such as Promedon TUBE, Rigicon Rigi10, Boston Scientific Tactra and Coloplast Genesis.
Among these, Promedon TUBE is promoted quite strongly in India, particularly around two ideas: rigidity and its long history as an international implant.
As a penile implant surgeon, however, I would look at the device from a slightly different perspective.
Before placing any permanent penile implant inside a patient, I would want clear answers to four questions.
Why does Promedon TUBE still use a twisted silver-wire core when silver-wire fracture has such a long history in penile prostheses?
Where is the independent evidence showing that Promedon is more rigid than modern alternatives?
Why does its contemporary American and major European footprint appear limited compared with other international penile prosthetic platforms?
And for a device promoted so heavily in India, why is there comparatively little international surgeon discussion and long-term published evidence around it?
Of these four questions, the first is by far the most important.
Why Silver-Wire Cores Historically Became Problematic
Promedon TUBE contains a twisted silver-wire core covered by protective material and silicone.
The basic engineering concept is not new.
One of the best-known early malleable penile prostheses was the Jonas prosthesis, introduced decades ago. It also used a silicone-covered structure built around silver wires.
The concept made sense.
The implant could remain sufficiently rigid for intercourse while still being bent downward for concealment inside clothing.
Initially, that seemed like an elegant solution.
Then reports of wire fracture began to appear.
A 1984 paper published in the Journal of Urology examined five consecutive silicone-silver-wire prostheses that had been removed.
When the devices were analysed, the investigators found multiple breaks involving all strands of the silver-wire core in both cylinders.
That is an important historical finding because it was not simply a theoretical concern about metal fatigue.
These were explanted devices in which actual structural wire failure had occurred.
A second paper, published in 1986, described failure of the Jonas prosthesis in greater clinical detail.
Patients developed decreasing rigidity, crackling within the prosthesis and radiological evidence of wire damage. In some cases, revision surgery confirmed complete multiple wire fractures.
This historical experience is important because it shows that repeated bending of a silver-wire penile implant can, at least in certain designs, lead to clinically relevant mechanical failure.
That does not mean every modern implant containing silver will behave the same way.
But it does mean that silver-wire fatigue is not a new or purely theoretical concern.
Penile prosthetic surgeons encountered this problem approximately four decades ago.
Why Does That History Matter for Promedon TUBE?
The reason is simple.
Promedon TUBE also uses a twisted silver-wire architecture.
That does not make it identical to the older Jonas prosthesis. Modern manufacturing, protective layers, wire arrangement and implant construction can all differ significantly.
However, the similarity becomes clinically relevant because modern Promedon-specific fracture reports also exist.
A 2016 clinical series examining Promedon TUBE prostheses documented mechanical failures caused by wire fracture.
So the concern is no longer based only on historical silver-wire devices.
It has also been reported in the modern TUBE prosthesis itself.
That is the key distinction.
If there were only old Jonas data, one could reasonably argue that modern engineering may have solved the problem.
But once fracture is also documented in contemporary Promedon TUBE studies, the question deserves a much more serious discussion.
Promedon TUBE Fracture Evidence
One of the main Promedon-specific studies was published in the Arab Journal of Urology in 2016.
The study evaluated surgical outcomes and complications of TUBE malleable penile prostheses in men with erectile dysfunction.
Overall patient satisfaction was reasonably good, but mechanical complications were also reported.
Importantly, some prostheses had to be removed because of wire fracture.
This makes wire fracture a documented clinical complication of the TUBE implant rather than a hypothetical engineering concern.
That does not mean every Promedon TUBE will fracture.
It does mean that patients should be told that such failures have been published.
The more important modern evidence came in 2026.
A Brazilian tertiary centre published 17 years of experience with malleable penile prosthesis fractures.
The study examined confirmed fracture cases involving Promedon prostheses.
Among the fracture population, the median time to fracture was approximately 59 months.
Bilateral fractures were present in 51.9% of revision cases, and recurrent fractures occurred in 28.2% of patients.
The authors concluded that malleable penile prosthesis fracture is a clinically relevant complication.
These numbers need to be interpreted carefully.
They do not mean that every Promedon TUBE breaks after 59 months.
The study was not designed to calculate the overall survival rate of all implanted TUBE prostheses.
It examined patients who had already developed fracture and required evaluation or revision.
So the correct interpretation is not:
“Promedon TUBE lasts only five years.”
The more accurate conclusion is that, when fracture occurs, it can be clinically significant, bilateral and occasionally recurrent.
That is still highly relevant when counselling a patient about a permanent implant.
Rigidity and Durability Are Not the Same Thing
Patients often confuse rigidity with long-term mechanical durability.
They are not the same.
A simple way to understand this is to think about a paper clip.
If you push directly against a metal paper clip, it can tolerate a surprising amount of force.
But if you repeatedly bend the same point backward and forward, metal fatigue eventually develops and the wire can break.
A penile implant is obviously far more sophisticated than a paper clip, but the mechanical principle is useful.
A malleable prosthesis is repeatedly repositioned.
Downward for concealment.
Upward for intercourse.
Then downward again.
And this process may occur thousands of times over many years.
That is why, for a permanent implant, I am less interested in a single axial-load number and more interested in what happens after years of repeated bending.
The question should not only be:
“How rigid is this implant today?”
The equally important question is:
“How well does the internal core tolerate thousands of bending cycles over ten or fifteen years?”
Does Every Silver-Containing Implant Fracture?
No.
That would be an exaggeration.
The word “silver” by itself does not make an implant unreliable.
Mechanical performance depends on many factors, including wire thickness, number of strands, twist pattern, protective layers, surrounding silicone, cylinder design, manufacturing quality and how mechanical stress is distributed through the implant.
Different manufacturers may use completely different engineering even when silver is part of the internal construction.
So my concern is not simply:
“Silver is bad.”
The concern is the combination of repeated bending, a twisted silver-wire architecture, documented historical fracture in earlier penile prostheses and documented modern fracture in Promedon TUBE.
That combination deserves to be explained clearly to a patient.
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What Did the Original Promedon Clinical Study Actually Report?
It would also be unfair to discuss Promedon TUBE only through the lens of fracture.
The original important clinical series published in 2007 included 83 patients and showed that the implant could provide useful functional outcomes.
Approximately 90.4% of patients reported successful intercourse.
That is an important positive finding.
However, the study also reported several limitations from the patient perspective.
Around 32.5% of patients felt that the prosthesis was too short.
Approximately 24% experienced nonspecific pain.
And 9.6% were dissatisfied with the appearance.
These findings matter because successful intercourse is only one part of penile implant satisfaction.
Patients also care about comfort, perceived length, concealability and cosmetic appearance.
So the original TUBE study gives a mixed but useful picture.
The implant clearly worked for many patients, but it was not free of dissatisfaction or discomfort.
Is Promedon Really the Most Rigid Malleable Implant?
Promedon promotes axial rigidity as one of the strengths of TUBE.
The implant can clearly provide sufficient rigidity for intercourse.
But “sufficiently rigid” and “the most rigid implant available” are not the same claim.
Different manufacturers test their devices using different implant diameters, different lengths, different machines, different loading methods and different failure definitions.
That makes direct comparison of brochure numbers scientifically difficult.
For example, one company may publish one type of axial-load result while another reports column strength or fatigue testing under a different protocol.
Those numbers should not automatically be treated as directly comparable.
If someone tells a patient:
“Promedon is the strongest malleable implant,”
the logical response is:
Where is the independent head-to-head study in which Promedon TUBE, Tactra and Rigi10 were tested side by side under exactly the same conditions?
Without that kind of evidence, it is reasonable to say that Promedon TUBE provides adequate rigidity.
It is much harder to scientifically prove that it is the most rigid modern malleable penile prosthesis.
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What About Its International Footprint?
Promedon is an international medical-device company.
TUBE is genuinely used outside India, particularly in Latin America.
But patients should distinguish between two very different statements:
“Internationally available”
and
“widely used in major American and European penile-implant centres.”
Those are not the same thing.
A device can be sold internationally without having the same adoption, surgeon familiarity or long-term evidence base in every major prosthetic market.
This point by itself does not prove that the implant is good or bad.
But it is reasonable for a patient choosing a permanent implant to ask how broadly that exact device is used internationally and where the long-term real-world data come from.
Why Is International Surgeon Discussion Important?
Surgeon discussion is not a scientific endpoint by itself.
But it can still be useful context.
A device with a long commercial history and broad international use would usually be expected to generate a substantial amount of independent surgeon education, conference discussion, long-term series and comparative research.
Promedon TUBE certainly has publications and international users.
However, compared with how prominently it is marketed to Indian patients, the amount of contemporary independent international discussion and long-term comparative evidence appears limited.
That does not make the implant unsafe.
But it is another reason patients should look beyond marketing language and ask for actual published evidence.
Is Promedon TUBE a Bad Implant?
That is not the most useful question.
Promedon TUBE can clearly provide enough rigidity for intercourse.
Published studies also show successful sexual function in many patients.
At the same time, wire fractures and mechanical failures have been documented.
So the real question is not whether the device should be labelled “good” or “bad.”
The real question is whether the benefits, limitations and long-term mechanical risks have been explained honestly before surgery.
For me, the most important concern remains the silver-wire core.
Historical silver-wire prostheses developed multiple fractures.
Modern Promedon-specific studies have also reported wire fracture.
And a 2026 tertiary-centre study showed that fracture can be bilateral and recurrent in some revision patients.
That does not justify telling every patient that the implant will fail.
It does justify telling every patient that the problem has been documented.
What Should an Indian Patient Ask Before Choosing a Malleable Implant?
If you are comparing Promedon TUBE with Rigi10, Tactra, Genesis or another malleable penile implant, do not ask only:
“Which implant feels the hardest?”
Ask what is inside the implant.
Ask what type of failure has been reported.
Ask whether fractures have occurred in published clinical studies.
Ask what revision surgery looks like if the implant breaks.
Ask how long the available follow-up data extend.
Ask whether there are meaningful 5-, 10- or 15-year data.
And ask how much experience your surgeon has with both the primary implantation and revision of that specific prosthesis.
A penile implant may remain inside the body for a decade or longer.
For that reason, the most important question about a malleable implant is not simply:
“How hard is it today?”
The more important question is:
“What happens after thousands of bends and many years inside the body?”
That is the question every patient deserves to have answered before surgery.
References
- Tawil E, Hawatmeh IS, Apte S, Gregory JG. Multiple fractures of the silver wire strands as a complication of the silicone-silver wire prosthesis. J Urol. 1984;132(4):762-763. PMID: 6471227.
- Tawil EA, Gregory JG. Failure of the Jonas prosthesis. J Urol. 1986;135(4):702-703. PMID: 3959190.
- Mohamed ER, Hammady AR, Eldahshoury MZ, et al. Surgical outcomes and complications of Tube® (Promedon) malleable penile prostheses in diabetic versus non-diabetic patients with erectile dysfunction. Arab J Urol. 2016;14(4):305-311. PMID: 27900222.
- Fathy A, Shamloul R, AbdelRahim A, et al. Experience with Tube (Promedon) malleable penile implant. Urol Int. 2007. PMID: 17940357.
- Horta M, Teixeira TA, Nagato DC, et al. Malleable Penile Prosthesis Fractures: Lessons Learned from 17 Years of Experience at a Tertiary Center in Brazil. Int Braz J Urol. 2026;52(5). PMID: 42391489.
Medical Disclaimer
This article is intended for patient education and discussion of published medical literature. It should not be considered a personalised recommendation for or against any specific penile implant.
Penile implant selection should be based on individual anatomy, medical history, previous surgery, fibrosis, infection risk, available implant sizes, surgeon experience and patient preference after consultation with a qualified urologist or andrologist.
