Boston Scientific and Coloplast IPP Failure Study

[newhope]

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

[Chris1967]

Analysis
Long-Term Survival Rates of Inflatable Penile Prostheses: Systematic Review and Meta-Analysis
Larry E Miller et al. Urology. 2022 Aug.
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Abstract

The purpose of this study was to determine long-term survival of inflatable penile prosthesis (PP) and identify potential factors that may influence device survival. We performed a systematic review of Medline, Embase, and the Cochrane Central Register of Controlled Trials for studies of men treated with inflatable PP with at least 5 years of device survival data. We performed a random effects meta-analysis to estimate device survival at 1, 3, 5, 10, 15, and 20 years of follow-up. The robustness of the meta-analysis results was evaluated in a 1-study removed sensitivity analysis and sources of heterogeneity among studies were investigated with subgroup analysis. In 12 studies (20,161 patients; median age 57 years), PP device survival was 93.3% at 1 year, 91.0% at 3 years, 87.2% at 5 years, 76.8% at 10 years, 63.7% at 15 years, and 52.9% at 20 years. The results of the meta-analysis were not significantly influenced by single study effects in a 1-study removed sensitivity analysis. In a subgroup analysis, 5-year device survival rates were 90.6% vs 82.1% (P = .01) comparing newer vs older studies; no other patient or study design characteristic was statistically associated with device survival rates. In conclusion, the median device survival time of an inflatable PP is approximately 20 years. The factors responsible for improved device survival in newer studies remain unclear and warrant further study.

Copyright © 2022 The Author(s). Published by Elsevier Inc. All rights reserved.

PubMed Disclaimer

[tooyoung]

Analysis
Long-Term Survival Rates of Inflatable Penile Prostheses: Systematic Review and Meta-Analysis
Larry E Miller et al. Urology. 2022 Aug.
Free article
Show details

Full text links
Cite

Abstract

The purpose of this study was to determine long-term survival of inflatable penile prosthesis (PP) and identify potential factors that may influence device survival. We performed a systematic review of Medline, Embase, and the Cochrane Central Register of Controlled Trials for studies of men treated with inflatable PP with at least 5 years of device survival data. We performed a random effects meta-analysis to estimate device survival at 1, 3, 5, 10, 15, and 20 years of follow-up. The robustness of the meta-analysis results was evaluated in a 1-study removed sensitivity analysis and sources of heterogeneity among studies were investigated with subgroup analysis. In 12 studies (20,161 patients; median age 57 years), PP device survival was 93.3% at 1 year, 91.0% at 3 years, 87.2% at 5 years, 76.8% at 10 years, 63.7% at 15 years, and 52.9% at 20 years. The results of the meta-analysis were not significantly influenced by single study effects in a 1-study removed sensitivity analysis. In a subgroup analysis, 5-year device survival rates were 90.6% vs 82.1% (P = .01) comparing newer vs older studies; no other patient or study design characteristic was statistically associated with device survival rates. In conclusion, the median device survival time of an inflatable PP is approximately 20 years. The factors responsible for improved device survival in newer studies remain unclear and warrant further study.

Copyright © 2022 The Author(s). Published by Elsevier Inc. All rights reserved.

PubMed Disclaimer

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".

[tooyoung]

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

[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.

[tooyoung]

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?

No not at all...it's even way worse.

A high-volume specialist told me directly, “Rigicon IPP is a piece of crap—I only install it so Wilson, the ‘godfather,’ won’t get upset.” Not surprisingly, Wilson gets a lot of money from Rigicon.

And I personally know infla 10 implantees whose devices leaked twice within 3 years..one of whom his newly wed wife left him because she felt the relationship will continue to be unstable.

Even the sugarcoated hoax study of rigicon infla 10 which is sponsored by rigicon itself and authored by Wilson(surprisingly) says its' survival rate post 3 year mark is 70%...again this number is way boasted than the reality.

And yes Rigicon is getting FDA clearances by paying money...there's also a "legitamte" criteria in FDA saying if a new device has the same design as other competitors, the new company has to pay some millions (I forgot the exact number) to get clearance without going through all the tedious testings and approvals.

[tooyoung]

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.

I don't deny the infant mortality concept and I don't think it invalidates my claims...yes failure curve doesn't follow normal distribution (bell curve) but what makes you think in a bimodal distribution the early surge of failures are lower than the latter surge ?

So my question is how high is the infant mortality of these devices ? Atleast we now can agree it's irreasonably high.

And I think anybody would assume that high infant mortality indicates crappy material and manufacturing.

Should we live finger crossed until the 5 year mark passes ? To live peacfully for few years/months untill the second surge (considering it's a bimodal distribution of failures) Some demographics couldn't afford living fingercrossed (not covered by insurance, newly wed, starting his career , has small kids....etc...etc)

Also why these 10+ years devices aren't intercepted on MAUDE if they do exist ?...why can't you believe a 10+ year device failure is a super unicorn ? This fact alone totally invalidates any claim of reasonable longevity.


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)

[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