Boston Scientific and Coloplast IPP Failure Study

[LastHope]

Another one for the Implant nerds who like reading papers

https://www.nature.com/articles/s41443-025-01154-y

Mechanical failure of inflatable penile prostheses: a 2025 snapshot and historical context


Steven K Wilson, John J Mulcahy, Tobias Köhler, Paul Perito, Ahmet Tevfik Albayrak, Alfredo Suarez Sarmiento

International Journal of Impotence Research, 1-5, 2025

Inflatable penile prostheses (IPPs) are the preferred surgical option for men with erectile dysfunction that is unresponsive to medical therapy, offering superior cosmetic and functional outcomes [1]. However, device reliability remains a clinical concern even after 5 decades of usage [2]. For the first 5 months of 2025, the United States (US) Food and Drug Administration’s (FDA) Manufacturer and User Facility Device Experience (MAUDE) recorded 1324 reports of American IPPs removed for adverse events [3].

Boston Scientific (Marlborough, USA) accounted for 586 (44.3%) events, while 738 (55.7%) were linked to Coloplast (Minneapolis, USA)[3]. A PubMed search identified 581 articles that analyzed MAUDE data across a broad range of implants, including cochlear implants [4], devices for benign prostatic hyperplasia [5], guidewires [6], nitinol stents [7], barbed sutures [8], intercranial devices for epilepsy [9], breast implants [10], nasal epistaxis balloons [11], dermal fillers [12], and many more. To the best of our knowledge, however, this is the first study to examine MAUDE reports for IPPs. Given that approximately 2,000 IPPs are placed each month in the US, the monthly number of explant procedures appears disproportionately high relative to the implanted population [3]. A closer analysis of the data is warranted to detect preventable adverse events.

[Kodixx]

If there are 25K (+/- 5K)) new implants each year, that means that at any point in time there are around 100K (25x4) implants that are less than 4 years old. If 50% of those failed, that'd be 50,000 revision surgeries, or around 12K revision surgeries per year ? Does anyone see numbers that would support that theory ?

Courage -- I think you're on to something there

- Chuck

a median of 48 months is pretty low. It means there are 50% of devices that fails within 4 years

I assume that's the median for devices that failed within the study period, not the median for all devices installed.

[Kodixx]

tooyoung, on "Thu Aug 28, 2025 3:05 pm" in a thread titled "Re: With implant does it work the same if you are turned on or not? Bloodflow to Penis not needed at all anymore?", it appears you wrote "I am implanted myself".

I am implanted myself.

https://www.franktalk.org/phpBB3/viewtopic.php?f=6&t=27058&hilit=implanted#p260121

But in this thread, it appears you said that you are a "penile implant candidate".

I have a severe venous leak...maybe from the beginning of my sexual life...pde5i fail at high doses..confirmed by 2 dopplers and I'm a penile implant candidate at the age of 27

I apologize in advance if I misread your posts. But if I did read them correctly, which one is it ?

Are you implanted, or not ?

- Chuck

[tooyoung]

tooyoung, on "Thu Aug 28, 2025 3:05 pm" in a thread titled "Re: With implant does it work the same if you are turned on or not? Bloodflow to Penis not needed at all anymore?", it appears you wrote "I am implanted myself".

I am implanted myself.

https://www.franktalk.org/phpBB3/viewtopic.php?f=6&t=27058&hilit=implanted#p260121

But in this thread, it appears you said that you are a "penile implant candidate".

I have a severe venous leak...maybe from the beginning of my sexual life...pde5i fail at high doses..confirmed by 2 dopplers and I'm a penile implant candidate at the age of 27

I apologize in advance if I misread your posts. But if I did read them correctly, which one is it ?

Are you implanted, or not ?

- Chuck

After that I said I'm implanted by a Cadillac so it was a clear joke....since implanters refer to penile prosthesis as Cadillac, Ferrari and sports cars to appeal to the retarded..who unfortunately make the majority of candidates/implantees esepcially at certain age group I won't say which..you know it .

And chuck you know it was a joke and you know I'm yet to be implanted yet you decided to play Sherlock holmes

[tooyoung]

If there are 25K (+/- 5K)) new implants each year, that means that at any point in time there are around 100K (25x4) implants that are less than 4 years old. If 50% of those failed, that'd be 50,000 revision surgeries, or around 12K revision surgeries per year ? Does anyone see numbers that would support that theory ?

Courage -- I think you're on to something there

- Chuck

a median of 48 months is pretty low. It means there are 50% of devices that fails within 4 years

I assume that's the median for devices that failed within the study period, not the median for all devices installed.

A sample is a sample....If I were to gather 1000 dead asslickers, and calculated how long did it take for them to die from asslicking and the median turned out to be 2 years from the start of asslicking , it doesn't really matter whether there are 1 million asslickers worldwide...total number of asslickers present won't change the fact.

[Courage]

*SNIP*
Courage -- I think you're on to something there

There isn't any other reasonable interpretation. Unfortunately this board has a nut who people are entertaining.

[tooyoung]

*SNIP*
Courage -- I think you're on to something there

There isn't any other reasonable interpretation. Unfortunately this board has a nut who people are entertaining.

[Kodixx]

tooyoung, no I actually don't know. I guess the Cadillac thing wasn't amusing so it wasn't evident. But like I said, I apologized in advance if I didn't read your messages correctly.

- Chuck

you know it was a joke and you know

[Kodixx]

tooyoung, yes, population size and time both make a difference. Using your example, if 10,000 engines out of 1,000,000 fail withing a year, that's different than 10,000 out of 1,000,000 failing within 15 years.

As others have pointed out, we all knew the risks -- both IPP and MPP -- and made decisions based on our individual tolerances for risk and feature preferences. You really aren't smarter than everyone else, you just enjoy hurling insults because you don't want to accept that others made decisions that were right for them, but wouldn't have been a good fit for you.

- Chuck

[tooyoung]

tooyoung, yes, population size and time both make a difference. Using your example, if 10,000 engines out of 1,000,000 fail withing a year, that's different than 10,000 out of 1,000,000 failing within 15 years.

As others have pointed out, we all knew the risks -- both IPP and MPP -- and made decisions based on our individual tolerances for risk and feature preferences. You really aren't smarter than everyone else, you just enjoy hurling insults because you don't want to accept that others made decisions that were right for them, but wouldn't have been a good fit for you.

- Chuck

Please stop creating a dumb fog ...it's as simple as population size won't affect median time to failure.

I'm criticizing current state of penile implants....neither do I care about who took which decisions nor do I address personal decisions...what's so difficult to understand ?

folks who are really sensitive to these matters and want soothing talk can go ahead and read asslicking posts or repeat videos of beneficiaries on youtube...or best of all stop being online on forums...didn't they get reassured already ? Or do they still doubt the presence of a reasonable reliabiliy and need continuous reassurance?