My opinion about Implant Longevity: - Worry is the Thief of Joy

[Jgoody]

Woody whenever you have time, if you want, it wuold be great if you could do the same research for boston scientific in order to have a comparison. Thanks!

August 2025 AMS700 reports analysis.

P.S Reports included in the excel sheet are ONLY those that included both device manufacture date and event date so we can analyse their lifespan.

Also there's usually 1 year delay between manufacture date and time of implantation. I didn't factor this in....I assumed that device manufacture date is the same as implantation date so actual numbers should be even lower.

Ok i'm not so good at numbers, but so from these MAUDE reports (which we understand are not conclusive for the whole population of implants) we can conclude that 34% of Coloplast fail before 5 years, while 54% of ams fail before 5 years. Correct?
Because by looking at experiences from this forum users i wuold have assumed that BSC was more durable than Titan, but MAUDE seems to contradict that

I would only interpret that as 34% of THOSE REPORTED failures were coloplast. Not 34% of total coloplast implants installed. Remember we're missing the denominator number (total implants installed) to run against these reported failures.
If 34% of titans & 54% of ams implants failed within 5 years it would be way too much & there would be no trust in outcome of surgery for implants. Medical device testing for implants is rigorous.

The anecdotal (one person's experience) negative issues we periodically see here makes sense because men are more likely to find & use this board for grievances when failures unfortunately happen to them. So failures obviously happen for reasons listed but statistically overall implants are well tolerated & successful. The odds are in our favor that they last longer than that.

[Jgoody]

Oh and if you just meant 34% & 54% of those reported failures being coloplast & AMS within 5 years that would be correct. I would say it's too small of a sample to definitively say that the Titan is superior to AMS tho. I think overall everything I've seen says their overall failure rate & lifetime is pretty similar. Titans seem to mainly fail at tubing but overall survival rates are similar & well over 5 years. We are more likely to read about anecdotal failures on this site.

But with an estimated 60,000 penile implants being performed per year around the world, hearing (or reading on FT) about the small overall percentage of failures is going to seem common, I imagine

[dentestes]

TooYoung my bro I like that you want to push for better durability for these IPP devices. It's a real travesty to have to invest 20K out of pocket and still have no guarantees on how long it'll last before a mechanical failure. I'd like to give you my perspective though. I dealt with a useless penis for 20yrs and have had my titan for 2yrs now and counting and the joy it has brought me more than makes up for any worry i have that it'll break. My attitude is literally we'll cross that bridge when we get there and i sure hope its a long time but again its out of my control

[Thisworld]

Back to your question... those percentages are for the sample that I claim to represent the total. But where did you get 34%...for both almost half last less than 5 years.
I think AMS durability is equal to Titan.

The 34% was taked from Woody maths referring only to the Coloplast report

From the 67 device failure events with device ages listed in the report, it appears that 21% of those failed 10+ years after implantation, 45% failed 5-10 years after, and 34% failed 0-5 years after. See tables below.

I understand your fish analogy, idk.. i guess it wuold help understand whats the discrimination factor for an event to be reported on MAUDE or not. Is it a possibility that events comings from older implantation (i.e. before 2015) get reported less?
Just guessing here. But that wuold make a world difference

[Jgoody]

Hmm. Ya I get the fish analogy too & can somewhat see how you could come to that conclusion from the Maude reports. I guess where I'm stuck at would be if there are so many implants being performed every year wouldn't there need to be way more than 71 failures to be able to say that their average lifespan is so short or what we see in the small samples?

I'm no simp or anything just like to learn & reason.

As I'm sure you know, large implant numbers like 60k (per year) would require large failure numbers, like 6k failures to be able to say that even 1% (in that example) are failing at that lifetime span/rate. Btw are all failures reported MAUDE do you know?

[Wooody]

The fish analogy, (and the MAUDE reports) don’t factor the fact that when the fish first started swimming in the lake, there were very few of them, but as the years went on, that number grew exponentially each year, and continue to. Hence, there is a much larger, and growing, number of younger fish in the lake. Oh, and by the way, these fish are from all over the world not just the US.

[AussieGuy81]

. Btw are all failures reported MAUDE do you know?

I would have those Maude reports with a grain salt, they're not accurate at all and completely useless without knowing the total amount of implants installed every year.
If you google ' Can there be duplicates in Maude reports?', it comes back with with this

'Yes, duplicates are very common in MAUDE reports, with some studies finding that a significant portion of the reports in the database are duplicates. This happens for several reasons, including manufacturers and operators submitting separate reports for the same adverse event, which can make the data incomplete and difficult to analyze accurately'

'Data inaccuracies: Duplicates contribute to a dataset that is incomplete, biased, and imprecise, making it difficult to determine the true incidence and prevalence rates of device-related problems. '

Basically the Maude reports are completely useless

[Jgoody]

Thanks guys!
Ya I just looked into that too & saw that Maude is elective so not mandatory to even report failures, which unfortunately would make it subject to under/over reporting. All that I have seen in terms of studies are the ones most of us are familiar with which are 87% survival rate of 5 years and 75% survival rate of 10 yrs. Then over 50% survival rate of 20 years. Now that's surely skewed by old folks not using em & potentially dying i would imagine. RIP

Weird but I actually can agree with all you guys points here
However I do remember learning about a statistical fallacy known as the law of small numbers bias & it was a common error made in statistics when one uses a small group of numbers to draw a conclusion on a large group of numbers & that may apply here?

[Wooody]

No matter how hard some here try to argue that MAUDE reports provide accurate sampling to determine the reliability of IPPs, I cannot be convinced that it is accurate and valid given it's voluntary, inconsistent, incomplete and inaccurate nature.

And yes, despite what some argue, I do not agree, and will never agree, that the number of implantations has no relevance.

ChatGPT
MAUDE's Major Limitations:

Underreporting: Not all adverse events are reported. Studies suggest that fewer than 1 in 10 adverse events are reported.

No denominator: You don’t know how many total devices were implanted—so you can’t calculate rates (e.g., 5 reports out of how many? 50 or 5,000?).

This means you can’t assess reliability or failure rates accurately from MAUDE alone.

Data quality varies: Reports are often incomplete, unverified, or lack clinical detail.

Bias: People are more likely to report when something goes wrong. No routine submission of successful outcomes or satisfied patients.

MAUDE is useful for spotting red flags, but it's not a reliable source to judge overall device reliability or safety.


Here's another AI response to "Can i rely on MAUDE adverse events reports to judge the reliability of penile prosthetic implants?"

It is not reliable to judge the reliability of penile prosthetic implants solely based on MAUDE (Manufacturer and User Facility Device Experience) adverse reports. While the MAUDE database can provide valuable information, it has significant limitations that prevent it from being a comprehensive or accurate measure of a device's reliability.

Why you cannot rely solely on MAUDE reports

Voluntary and inconsistent reporting: The data in MAUDE is based on voluntary reporting, and the information can be incomplete, inaccurate, or biased. A high number of reports may not reflect a higher failure rate, but rather a higher market share or more diligent reporting by certain manufacturers or facilities.

No comparison data: The database does not track the total number of devices sold or implanted. Therefore, you cannot use it to calculate an actual adverse event rate or compare event rates between different manufacturers.

Unverified causality: A report in the database does not prove that the device caused or contributed to the event. Reports may be submitted for issues that are part of the known risks of the procedure, are a result of user error, or are unrelated to the device's function.

User error vs. device malfunction: Adverse events can be caused by surgical technique, patient comorbidities (such as diabetes), or failure to follow post-operative instructions, rather than a device defect.

Incomplete and delayed information: Reports may lack crucial clinical details or be submitted long after the event occurred, complicating efforts to accurately interpret them. Some firms may also withhold or delay reports.

How to use MAUDE reports correctly

MAUDE is best used as a tool to identify potential safety signals and trends, not to calculate failure rates or compare devices.

Qualitative analysis: Look for patterns in the event narratives, such as recurrent failure modes for a specific model or manufacturer. This can help you understand the types of problems that can occur.

Complementary information: Use MAUDE data alongside other sources of information, such as:
Scientific literature: Look for clinical studies and meta-analyses published in reputable medical journals that provide reliable, evidence-based data on implant complications and long-term outcomes.

Consultation with a specialist: Discuss device-specific reliability and complication rates with your urologist. They have firsthand experience with different devices and manufacturers.

Clinical trial data: Review the premarket data that the FDA used to approve the device.
Track changes over time: Monitor trends in reporting over time to see if a manufacturer has improved its devices or if a new problem has emerged.

In summary, MAUDE can alert you to potential issues with a device, but you should not use it as your sole resource for judging reliability. It is a starting point for further investigation using reliable scientific and clinical sources.

[Thisworld]

Very interesting topic, guys. I think Tooyoung is right in his assumption that even without a denominator, one can estimate life expectancy from the median failure times reported in MAUDE. At the same time, Woody/GPT’s argument also makes sense: MAUDE reports are voluntary, meaning that patients who get 10 years of use from their device are far less likely to report it.

I would also like to add that if someone doesn’t trust official studies about failure rates, it is still possible to form a general idea of IPP life expectancy from studies that mainly address other purposes but indirectly provide data on device failures during the study period. For example: https://bacandrology.biomedcentral.com/ ... 21-00123-x

That being said, I prefer not to focus on things I cannot control, but rather on the things I do have influence over. So the real question we should ask is: how can we extend the life expectancy of these devices?

Cylinder leaks → Could avoiding pumping to the maximum 100% reduce the likelihood of leaks?

Tubing breaks → Could avoiding twisting the pump while inflating help prevent this?


After all, we are talking about hydraulic devices manufactured in series, so they are likely very similar. If some last 10 years, then (excluding defective units that fail within the first few months),it seems reasonable that others of the same series could last just as long, provided we adopt a few precautions.
Actually it wuold be interesting starting a thread specifically for discuss this potential strategies
What do you think?