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

[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.

[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

[LetoMan]

tooyoung, no I actually don't know.

Kodixx, tooyoung has also claimed to be a doctor - lol - and is likely operating multiple accounts.

viewtopic.php?t=26145&start=20

Why? Who knows. There are some really weird people in this world.

Guys should stop engaging with him, other than to point out he is an idiot lest newbies considering an implant takes what he says as having any validity at all.

Be well, Leto

[Kodixx]

Leto, I get what you're saying and appreciate the message. He says he's on a quest to fight an evil industry for the good of mankind, but most of the time focuses on being condescending and hurling insults at others. Real "listen to me, I'm the smartest guy in the room" behavior.

And not sure about the Dr thing. For example, awhile back he changed his avatar pic to a side of beef with my FrankTalk pseudo-name "Chuck" at one end of the "cow". I'm guessing he believes he associated "Chuck" with the ass-end of a cow. So I have a hunch he simply failed to read the anatomy diagram of a side of beef correctly. I've gotten a good Chuck'le out of that.

But if that's not the case -- then I'm honored to have my FrankTalk pseudo-name "Chuck" associated with one of the more versatile, economical and good tasting cuts of beef

- Chuck

tooyoung, no I actually don't know.

Kodixx, tooyoung has also claimed to be a doctor - lol - and is likely operating multiple accounts.

viewtopic.php?t=26145&start=20

Why? Who knows. There are some really weird people in this world.

Guys should stop engaging with him, other than to point out he is an idiot lest newbies considering an implant takes what he says as having any validity at all.

Be well, Leto

[fucked0ne]

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?

Any idea when the new Coloplast tubing should become available? And where did you happen to hear about this? It’s my understanding that the Coloplast, excepting the tubing, is pretty fucking resilient; new tubing made of the same sturdy material could set Coloplast firmly above BostonScientific in the world of IPPs (and force BS to make some positive, competitive changes themselves). If what you say is true, this is actually exciting news.

[sambalamba]

Any idea when the new Coloplast tubing should become available? And where did you happen to hear about this? It’s my understanding that the Coloplast, excepting the tubing, is pretty fucking resilient; new tubing made of the same sturdy material could set Coloplast firmly above BostonScientific in the world of IPPs (and force BS to make some positive, competitive changes themselves). If what you say is true, this is actually exciting news.

I have heard some docs say around 2030.No published data exists to back that claim up.

FDA approvals in 2025 for Titan are PMA supplements (updates), not a new device line:

Aug 14, 2025 – Supplement S071: design/component changes to True Lock parts in the Titan assembly kit and a new pouch sealer. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?ID=P000006S071

May 28, 2025 – Supplement S070: approval of an alternate sterilization site for Titan assembly kits and RTEs (manufacturing/sterilization logistics). https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?ID=P000006S070

Coloplast has recent IP activity that suggests R&D:

2024 US patent application describing a prosthesis with a “scaffold nested inside a tubular film” and a pump assembly—signals concept work, not a launched product. https://patents.google.com/patent/US20240033087A1/en

2025 US design patent on a deflation button for an implantable penile prosthesis pump—again, component-level refinement. https://patents.justia.com/patent/D1086084