Boston Scientific and Coloplast IPP Failure Study

[Thisworld]

these devices are just hard plastic tubing, they should be bullet proof. The fact that they break within few years imho is a shame

These companies want to make more profit on the behalf of very vulnerable men that can't do anything else. And each revisions increases chances of infections and other terrible outcomes

There should be a class action against these companies

Couldn’t agree more. In an oligarchy, class action isn’t gonna do much—especially when there’s a whole flock of arsekissers who act like using their brains might give them a headache. They instead choose to “trust” the beneficiaries and go around parroting their narrative. That’s why we keep hearing those cultish catchphrases like “I got my penis a Cadillac,” “It doesn’t affect sensitivity,” “My penis will get bigger with the next revision,” and much more nonsense.

The only way forward is to give proper feedback to these companies and future implantees—and for the hyped-up arselickers to chill out a bit.

#1 month going strong
#medicare
#trust your surgeon
#I love my new toy
#boomers
#best thing I ever did to myself

Speaking of oligarchy, You think rigicon ipp is any better in term of reliability?

[Chris1967]

Rigicon has improved all error sources and has applied four coatings. They have also developed a new pump.

[ElbowRoom]

Then why is it that over 90% of failures reported in the MAUDE (FDA) database occur before 10 year mark? We’re seeing multipe failures within just a few years—statistically by this hoax study, this should be extremely rare, yet it’s a common scenario. No wonder implantees celebrate passing the 1-month and 6-month marks with fingers crossed, as if their lives are supposed to revolve around this crappy device.

Hell even doctors (beneficiaries) refuted this study saying it's exaggerating and you casually copying & pasting it as if you done your "homework".

Failures are not linear. It’s very likely that when failures occur, they occur earlier in device life (called “infant mortality” in failure analysis). So an implant that survives 5 years is likely to survive more than 10, and one that makes it 10 is likely to survive to 20.

This data suggests the failure curve shows higher device failure inside of 5 years, and lower failure rates between years 5-10. There are probably more failures after year 10, but not as many as before year 5.

In other words, if you make it past year 5 you’re more likely to reach year 10 or year 20 than somebody newly implanted.

[Rider1400]

So the way I read the article is the study is on a group of people who came in needing a revision. So they are gathering data on the failed IPPs I see no percentage of failure rate. Only thing discussed is what caused failed in this group that needed them. Could only guess that the Drs that did the revisions might not have even done the original implant. So if I used a so so Dr to do my implant and I had a failure, then I would definitely go to one of the higher volume Drs to get a revision. A lot of Drs won’t even do revisions! No corolation between how many implants were done in the given time frame in the USA!! Only data on the ones that came in for revision. I’m sure you will but correct me if I’m wrong

[ElbowRoom]

And yeah why coloblast and Bullshit scientific have reduced their warranties to 5 years ?? Doesn't that say something ? And only for mechanical failures...if you aren't insured and paid out of pocket and caught an infection, erosion or needed replacement for any other reason good luck taking bank loans and going to prison If you haven't already exhausted your family savings. (God forbid and save you all)

Making fun of manufacturers doesn’t bolster any arguments you make, it makes you look childish. If you want to be taken seriously you have to discuss it as if you’re a serious person.

Coloplast has a 10 year warranty. It originally had a lifetime warranty. It’s standard for many products in their earlier stages to have stronger warranties in order to strengthen consumer confidence. Lifetime is probably too ambitious, especially considering that there seem to be more younger patients getting implants now.

10 years is a reasonable warranty period. Any company wants to set their warranty where they feel the large majority device life will exceed the warranty period, to minimize warranty claims and “giving away” money. That shows Coloplast expects implants to last over ten years, with some unavoidable exceptions.

[Wooody]

So the way I read the article is the study is on a group of people who came in needing a revision. So they are gathering data on the failed IPPs I see no percentage of failure rate. Only thing discussed is what caused failed in this group that needed them. Could only guess that the Drs that did the revisions might not have even done the original implant. So if I used a so so Dr to do my implant and I had a failure, then I would definitely go to one of the higher volume Drs to get a revision. A lot of Drs won’t even do revisions! No corolation between how many implants were done in the given time frame in the USA!! Only data on the ones that came in for revision. I’m sure you will but correct me if I’m wrong

When failed ipps fail after two years (median) doesn't that tell you something ? Did they cherry pick devices that failed early ?... SIMPLY if ipps commonly fail after 10 yrs+ , the median time to failure wouldn't have been 2 years...or you would commonly see devices that had survived 10+ years on MAUDE database or here on this miserable forum or on reddit or anywhere.

"Only data on the ones that came for revision"....and those devices that fail after 10+ years don't come for revisions ??where did they go ? SIMPLY given that these devices inevitabley fail where do long survivors go ? And don't tell me busy fucking nobody fucks with a failed implant
I hope you see the idea.

And what do "high volume implanters" have anything to in this topic? Their hands regardless of their high competence won't be magically blessing the crappy mechanical material for better longevitiy...whether tubings in Titan or every piece in AMS.

Sorry for the language...I'm fighting the thought not you personally...you have all my respect truely.

Bottom line, I assume you want more reliable and dependable IPP's, right? We all do. How about some recognition now that when Titans fail, it is overwhelmingly because of tubing failure and they are actively taking steps to fix this problem. Their cylinders made with Bioflex have been very reliable, same with their classic pumps. Now they're looking to fix their weakness and make the tubing out of the same Bioflex material.

What is Boston Scientific doing to improve the reliability of their cylinders, pumps and tubing? This is why my Dr stopped using BS products btw.

Tooyoung... I don't cross my fingers or even think about failure with my Titan... I'm enjoying being free of ED, having sex with my fiance 5-6 days a week, often multiple times a day... and, I'm close to 60. Device usage has less to do with age than it does your libido and if you have a partner(s) to play with regularly so stop throwing the old timers / boomers crap around. I know tons of young guys not getting any action, even without ED! Do you have an implant? Do you even have ED? Serious question.. do you walk in any of our shoes?

[daddel]

And yeah why coloblast and Bullshit scientific have reduced their warranties to 5 years ?? Doesn't that say something ? And only for mechanical failures...if you aren't insured and paid out of pocket and caught an infection, erosion or needed replacement for any other reason good luck taking bank loans and going to prison If you haven't already exhausted your family savings. (God forbid and save you all)

Making fun of manufacturers doesn’t bolster any arguments you make, it makes you look childish. If you want to be taken seriously you have to discuss it as if you’re a serious person.

Coloplast has a 10 year warranty. It originally had a lifetime warranty. It’s standard for many products in their earlier stages to have stronger warranties in order to strengthen consumer confidence. Lifetime is probably too ambitious, especially considering that there seem to be more younger patients getting implants now.

10 years is a reasonable warranty period. Any company wants to set their warranty where they feel the large majority device life will exceed the warranty period, to minimize warranty claims and “giving away” money. That shows Coloplast expects implants to last over ten years, with some unavoidable exceptions.

Don’t feed the troll, mate.

He’s 27. Texting in an immature and childish way. He has no experience with IPPs himself. And he has no interest in getting one. Every single post is about ranting against IPPs and it’s reliability. He jumps on every thread and posts the same things like a small dog, biting the leg of someone and not letting it go. Arguments are exaggerated, single sided view.

Repeating same things over and over again. Yes, we know devices break. We know.

The question is: What is his mission here? What does he want to achieve? It’s all more than suspicious..

[Courage]

Making fun of manufacturers doesn’t bolster any arguments you make, it makes you look childish. If you want to be taken seriously you have to discuss it as if you’re a serious person. *[SNIP]*

Don’t feed the troll, mate.
*[SNIP]*
The question is: What is his mission here? What does he want to achieve? It’s all more than suspicious.

He's a nut. There's no reason to try to explain nuts. 'Cos they're nuts.

[fucked0ne]

Rigicon has improved all error sources and has applied four coatings. They have also developed a new pump.

Yeah, but only time will tell; the Rigicon is still just a baby.

[LastHope]

Another similar study summary by Smelser et al:

Mechanical indications for inflatable penile prosthesis revision: analysis and implications for revision surgery

Ashton M Smelser, Maia E VanDyke, Samantha W Nealon, Shervin Badkhshan, Brian T Langford, Josh Peedikayil, Al-Frooq El-Eishy, Thomas F Monaghan, Sarah C Sanders, Bryce P Franzen, Allen F Morey

The Journal of Sexual Medicine 20 (7), 1044-1051, 2023

https://academic.oup.com/jsm/article-ab ... ogin=false

Background
Despite technical advancements, inflatable penile prostheses (IPPs) are inherently at risk of mechanical failure given their nature as hydraulic devices.

Aim
To characterize IPP component failure location at the time of device revision and stratify by manufacturer: American Medical Systems (Boston Scientific [BSCI]) and Coloplast (CP).

Methods
A retrospective review of penile prosthesis cases from July 2007 to May 2022 was conducted, identifying men who underwent revision surgery. Cases were excluded if documentation did not denote the cause of failure or the manufacturer. Mechanical indications for surgery were categorized by location (eg, tubing, cylinder, or reservoir leak; pump malfunction). Nonmechanical revisions were excluded (component herniation, erosion, or crossover). Categorical variables were assessed with Fisher exact or chi-square analysis; Student t-test and Mann-Whitney U test were used for continuous variables.

Outcomes
Primary outcomes included specific location of IPP mechanical failure among BSCI and CP devices and time to mechanical failure.

Results
We identified 276 revision procedures, 68 of which met inclusion criteria (46 BSCI and 22 CP). Revised CP devices were longer than BSCI devices (median cylinder length, 20 vs 18 cm; P < .001). Log-rank analysis revealed a similar time to mechanical failure between brands (P = .096). CP devices failed most often due to tubing fracture (19/22, 83%). BSCI devices had no predominant site of failure. Between manufacturers, tubing failure was more common in CP devices (19/22 vs 15/46 for BSCI, P < .001), while cylinder failure was more common among BSCI devices (10/46 vs 0/22 for CP, P = .026).

Clinical Implications
The distribution of mechanical failure is significantly different between BSCI and CP devices; this has implications regarding the approach to revision surgery.

Strengths and Limitations
This is the first study to directly compare when and where mechanical failure occurs in IPPs and to compare the 2 main manufacturers head-to-head. This study would be strengthened by being repeated in a multi-institutional fashion to provide more robust and objective evaluation.

Conclusion
CP devices commonly failed at the tubing and rarely elsewhere, while BSCI devices showed no predominant failure site; these findings may inform decision making regarding revision surgery.