Following up on questioning IPPs reliability

[easymoney]

Being implanted with a Rigicon ..and having to have it replaced a year later due to undersizing .. I wonder what the numbers are for MPP's not for failure since few do ..but for being undersized? ... When i went in to have mine replaced ..across the way I overheard a conversation .. another man ..same dr. was in there fore a revision dues to undersizing.

[Wooody]

Short of a long range tracking study of a meaningful number of young implantees who use the device to failure, you're not going to get at anything useful about reliability.

Agreed. Both the Coloplast 30% stat and the monthly revisions reports that keep getting thrown around as some proof that IPP's are unreliable are missing vital data points. How many of those revisions were not in fact device failures but the result of infections, under or over sizing errors, erosion, underfillment of reservoirs, etc etc? How old was each original implant? Maybe they were all over 10 years, 15 years? Maybe they were all under 5 years.. who knows?

[tooyoung]

Short of a long range tracking study of a meaningful number of young implantees who use the device to failure, you're not going to get at anything useful about reliability.

Now we are getting somewhere...that long term reliability is questionable.

Yes there's no long term tracking for younger folks but if there will ever be, it will a study sponsored by Boston scientific and coloplast with their affiliated surgeons.

However, MAUDE reports (a big shout out to Lasthope), coloplast 30% yearly revision rate statistic, anecdotes and multiple failures within few years are very sufficient to tell Ipps reliability sucks.

[tooyoung]

There are much better statistical analyses available like this one:
https://www.sciencedirect.com/science/a ... 9522002680

It answers my question of how likely is it that my IPP will still be working in 5 years? 7 years? I have no idea what the 30% figure means or how I’d use it to predict the likely useful life of my device.

Ohh again that con study...even clavell, Eid, david ralph and bunch others said these numbers are absurd and 8-12 years are more plausible from their practice. Also Eid's contingency for this span is that it's being used not more than one or two times per week.

I'm here refuting the proclaimed 8-12 span not the hoax study.

[tooyoung]

Being implanted with a Rigicon ..and having to have it replaced a year later due to undersizing .. I wonder what the numbers are for MPP's not for failure since few do ..but for being undersized? ... When i went in to have mine replaced ..across the way I overheard a conversation .. another man ..same dr. was in there fore a revision dues to undersizing.

I won't advise anybody to do a malleable in u.s/europe not because they are shit surgeons but because they are extremely inexperienced with malleables even the "big names".

[Courage]

Agreed. Both the Coloplast 30% stat and the monthly revisions reports that keep getting thrown around as some proof that IPP's are unreliable are missing vital data points. How many of those revisions were not in fact device failures but the result of infections, under or over sizing errors, erosion, underfillment of reservoirs, etc etc? How old was each original implant? Maybe they were all over 10 years, 15 years? Maybe they were all under 5 years.. who knows?

There's that. More importantly, most implants are put in old men with compromised health. If the patient predeceases the implant--ie dies before it stops functioning--those can't be properly accounted for in any meaningful way.

Respectfully, this discussion is nonscientific and isn't going to get better.

[tooyoung]

Short of a long range tracking study of a meaningful number of young implantees who use the device to failure, you're not going to get at anything useful about reliability.

Agreed. Both the Coloplast 30% stat and the monthly revisions reports that keep getting thrown around as some proof that IPP's are unreliable are missing vital data points. How many of those revisions were not in fact device failures but the result of infections, under or over sizing errors, erosion, underfillment of reservoirs, etc etc? How old was each original implant? Maybe they were all over 10 years, 15 years? Maybe they were all under 5 years.. who knows?

Yeah revisions in general...Does doing a revision due to reasons other than mechanical malfunction makes it any better?

And yes revisions involve old implants (been there for some years) and new implants.... how does that change the argument ? How does it change the ratio ? Yearly revisons(for new + old implants) to yearly implantations (revision + virgin cases)

I like how you ditched MAUDE (FDA) and coloplast statistic because you didn't like it ...
Scary numbers yeah...let's burry our heads and not only that...let's become propagantists ourselves and let those crappy devices thrive without any possibility of correction.

[tooyoung]

Agreed. Both the Coloplast 30% stat and the monthly revisions reports that keep getting thrown around as some proof that IPP's are unreliable are missing vital data points. How many of those revisions were not in fact device failures but the result of infections, under or over sizing errors, erosion, underfillment of reservoirs, etc etc? How old was each original implant? Maybe they were all over 10 years, 15 years? Maybe they were all under 5 years.. who knows?

There's that. More importantly, most implants are put in old men with compromised health. If the patient predeceases the implant--ie dies before it stops functioning--those can't be properly accounted for in any meaningful way.

Respectfully, this discussion is nonscientific and isn't going to get better.

Thank you and this is called attrition bias...tell me how attrition bias will change the ratio or statistic ? How them living longer will change the ratio ?

Yearly revisions / yearly implantations (revision + virgin cases)

And since they won't be virgin cases (as they were implanted already) they wouldn't be changing the ratio if they were to live longer.

[LiverpoolLad]

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^^

Where is the implant rep when you need him? I’m not an implant cheerleader but for there to be a revision rate that high for implants inserted in that same year doesn’t make sense tooyoung..

You have MAUDE numbers lasthope publish monthly...it's about ~350 failures per month...given that 20-25k implants are installed anually in the U.S (keep in mind this is inclusive of mpps and that this number is published by companies and affiliated surgeons)...the ratio of failure (old or new implants) vs new implantation (revision + virgin cases) is 4.2k:22.5k is approx 0.2 which is 20% yearly failure.

It's just that the desperate like ourselves find it better to burry our heads in the sand for our mental wellbeing but that doesn't change the reality.

Do you understand that the 20-30% revisions you talk about, will be based on all implants not directly from the 20-25k figure you’re talking about. I understand this is added to the overall figure by nature, however basing the percentage from the 20-25k figure isn’t the way to work it out. There’s far more to it as ElbowRoom has said.

Anyway when are you going to stop yapping and get an implant? I suspect you’ll be one of the guys to find something to complain about anyway due to how you are interacting with others on this site.

[UpNorth]

Do we know what percent are from experienced surgeons?
Or, what percent is the classic and percent of one touch?

I just can’t fathom that insurance companies would dish out that kind of money if they had a 30% failure rate.