Following up on questioning IPPs reliability

[frank66665]

1 in 3 operations is a revision...isn't that high ?

There is no data on how many operating plants there are in circulation, consequently 20/30% of revisions on the operations of the current year could be too few if we take numbers from 20 years to today, while the revisions refer to the current year

And the years before don't they have revisions as well ? At least they were 30% annually too...if you take the 20 years total implants in perspective, put the 20 years of revisions too...sorry but it's making me sick how esteemed contributers here including you couldn't put it into perspective.

1 year revisions ÷ 20 years total installations===>that's elbowroom's fog (MATHEMATICALLY WRONG)

20 year revisions ÷ 20 years total installations===> common sense and simple math

And without all that meticulous analysis which untill now stands by my side , 1 in 3 surgeries is a revision ..this is huge...a 5th grader will say it's fucking big...and will not by anyway translate into perito and the rest con claims...it should be 1 in 50 or so...what's wrong with you guys ?

Let me give you a hypothesis: if in 2024 they performed 10,000 operations, 30% of them are 3,000 inspections. In the previous 20 years there were 10,000 x 20 years = 200,000 thousand systems. If every year they perform 3,000 inspections out of 10,000 operations, the math says that the inspections are 1.5% of all existing systems. Obviously the percentage increases because in the previous 19 years inspections were performed every year. Generally speaking, it can be estimated at around 8-10%.

[LetoMan]

Why you guys are feeding the trolls is beyond me. This guy lacks a basic understanding of scientific method. And has falsely claimed to be a doctor, too! The only way to deal with trolls is to ignore them. They thrive on attention.

[Wooody]

1 in 3 operations is a revision...isn't that high ?

There is no data on how many operating plants there are in circulation, consequently 20/30% of revisions on the operations of the current year could be too few if we take numbers from 20 years to today, while the revisions refer to the current year

And the years before don't they have revisions as well ? At least they were 30% annually too...if you take the 20 years total implants in perspective, put the 20 years of revisions too...sorry but it's making me sick how esteemed contributers here including you couldn't put it into perspective.

1 year revisions ÷ 20 years total installations===>that's elbowroom's fog (MATHEMATICALLY WRONG)

20 year revisions ÷ 20 years total installations===> common sense and simple math

And without all that meticulous analysis which untill now stands by my side , 1 in 3 surgeries is a revision ..this is huge...a 5th grader will say it's fucking big...and will not by anyway translate into perito and the rest con claims...it should be 1 in 50 or so...what's wrong with you guys ?

Can you prove that revisions actually started 20 years ago? Saying "at least they were 30% annually too" is complete assumption. I only see 30% revisions claimed for 1 year. You have NO proof, yet you assume what you believe is fact. There is SO much missing data to try to prove one way or the other.

And again, you are trying so hard to claim IPP' products are unreliable, but refuse to accept that there is a difference between product failure and installer and even patient failure that affects the statistics as well as a lot of missing data that is needed to PROVE your claim.

You want to do meticulous analysis? I just looked at the first 22 reports on the June MAUDE. I don't have time to do the rest. 11 of them are not defective device issues: infection, erosion, kinked hose from installation, herniated reservoir, malposition of device, patient difficulty deflating device but device tested operative, etc. The other 11 were and their dates of manufacture: 2013, 2015, 2017, 2017, 2018, <2018 (didn't give exact date), 2019, 2021, 2023, 2024, 2024. Want to analyze the rest and discuss?

[Wooody]

Why you guys are feeding the trolls is beyond me. This guy lacks a basic understanding of scientific method. And has falsely claimed to be a doctor, too! The only way to deal with trolls is to ignore them. They thrive on attention.

Yeah, you're right. I'm done.

[tooyoung]

Why you guys are feeding the trolls is beyond me. This guy lacks a basic understanding of scientific method. And has falsely claimed to be a doctor, too! The only way to deal with trolls is to ignore them. They thrive on attention.

Is that how you defend your clients in court ?

Poor guys sentenced for eternity because of your lame troll card.

[tooyoung]

There is no data on how many operating plants there are in circulation, consequently 20/30% of revisions on the operations of the current year could be too few if we take numbers from 20 years to today, while the revisions refer to the current year

And the years before don't they have revisions as well ? At least they were 30% annually too...if you take the 20 years total implants in perspective, put the 20 years of revisions too...sorry but it's making me sick how esteemed contributers here including you couldn't put it into perspective.

1 year revisions ÷ 20 years total installations===>that's elbowroom's fog (MATHEMATICALLY WRONG)

20 year revisions ÷ 20 years total installations===> common sense and simple math

And without all that meticulous analysis which untill now stands by my side , 1 in 3 surgeries is a revision ..this is huge...a 5th grader will say it's fucking big...and will not by anyway translate into perito and the rest con claims...it should be 1 in 50 or so...what's wrong with you guys ?

Can you prove that revisions actually started 20 years ago? Saying "at least they were 30% annually too" is complete assumption. I only see 30% revisions claimed for 1 year. You have NO proof, yet you assume what you believe is fact. There is SO much missing data to try to prove one way or the other.

And again, you are trying so hard to claim IPP' products are unreliable, but refuse to accept that there is a difference between product failure and installer and even patient failure that affects the statistics as well as a lot of missing data that is needed to PROVE your claim.

You want to do meticulous analysis? I just looked at the first 22 reports on the June MAUDE. I don't have time to do the rest. 11 of them are not defective device issues: infection, erosion, kinked hose from installation, herniated reservoir, malposition of device, patient difficulty deflating device but device tested operative, etc. The other 11 were and their dates of manufacture: 2013, 2015, 2017, 2017, 2018, <2018 (didn't give exact date), 2019, 2021, 2023, 2024, 2024. Want to analyze the rest and discuss?

Experts you love say revision rates are getting better by time due to better technology, techniques and lab lab laa...this means previous revision rates were not less than 30% if not more..

And wow do you need a proof that revisions have been going on since implants introduction ?

And yes I'm talking about all revisions stats and haven't said other than that... does that make numbers any better ? Is a kinked tube or a bulging reservoir reliable to you ?

Can't u see the dates you mentioned speak for themselves..

No i will save you some time...out of june's 326 total 284 are confirmed mechanical issues.

[LastHope]

Kaplan Meier Analysis is the gold standard method for analyzing device survival rates and is better than the AFRs calculated here, because KMA shows how survival fluctuates over time, example: X% of implants are still working at year 1, 5, 10, 15, 20 years. KMA also gives early infact mortality rates, stable midlife rates and late mechanical wear-out rates.

Annual Failure Rate =
100 *
[Number of virgin implanted devices that had mechanical failures in a given year] / [Number of virgin devices that are still cycling and have not yet failed]

We don't have this denominator to calculate AFR rate.

We can't make assumptions here on the denominator. That's a fatal flaw.

AFR also assumes constant device failure rate, which is not meaningful in the real-world for mechanical devices that wear out.

That said, I agree with TooYoung that in 2021: 1 out of 3 Coloplast IPP surgeries are revision surgeries.

Coloplast's marketing team is smart, they chose 2021, a pandemic year with 31% fewer elective surgeries!

[fucked0ne]

I'm sorry, no...my calculation is correct. The cited stat is that 30% of surgeries performed per year are revisions. NOT revisions of original surgeries PERFORMED that year. Those revision surgeries could have been for implants implanted the same year or 20 years previously. So you have to look at the total number of working implants in place across all years, and then divide by the number of revision surgeries performed to get the failure rate.

Since only Coloplast surgeries were cited, we can assume probably as many revisions were performed using AMS...so double the rate I quoted and you end up with 3-4% failures per year. Do you really think IPPs have a 20% failure rate in the same year they are implanted? That's ludicrous and there would be recalls on them immediately, no medical device could be FDA approved with that failure rate.

I'm not being biased I'm making reasonable assertions about the stats. If anything my numbers are conservative as I only cited 200,000 implants in use and only went back 20 years. There are probably more than that in place and some in operation longer than 20 years.

I'm not cheerleading anything, I'm looking objectively at the failure rates and I'm neither cheerleading nor "doon and gloom" about IPPs. I'm pre-op on my implant and believe me I would not serve my own purposes by barreling headlong into a surgery that would likely end up as a personal disaster. If I thought that was the case or the data supported that, I'd say so and cancel my scheduled surgery.

This is correct.

That's it ?....Is that the positive attitude your psychiatrist told you to adopt ?
Do you have any valuable appraisal to add other than "positive attitude"?

Duke has an MPP, so if he’s expressing a positive attitude it’s at least unbiased.

Personally, all these percentages are hieroglyphics to me. I did see a study once that was funded by neither Coloplast nor Boston Scientific which showed the average lifespan of the IPP to be about six years. This seems to jive with what I see frequently on this board, though I don’t remember exactly how the study was conducted and the average measured.

I used to be really terrified about breaks, not because of infection but because of inconvenience. Hakky sent me a study which showed ketogenic diets significantly mitigate risk of infection. (No, I no longer have the study; if anyone is interested, they should contact Hakky’s office.) Everything is what it is, though, if that is the average timeframe for revision, I assume at some point I’ll eventually have to move onto an MPP with filler.