100% chance of infection after 5 revisions.

[Discovernew]

So the n=2 on the relevant cohort? Two guys? That's it? It's impossible to generalize from a sample so small.

I agree about the 2/2, but if you would take everyone starting from the 3rd revision and above, it would be 22 guys and chance would still be more than 33%, which is huge.

The 3rd revision study with 33.3% rate is still powered only by 12 guys, so from a statistical standpoint the study is still highly underpowered.

For surgeons, this study can be useful in a medico-legal setting because it bolsters the argument that infections in such settings are driven by the number of prior revisions rather than surgical error!

It is not "only 12 guys" if you add up all guys with 3 revisions or more, its 22 guys, and all of them have 33% or higher. Which is huge. 33% is a 1/3rd or more chance to get infected.

Of course, i wish someone will come up with a new study that contradicts this one.

[lasthope2.0]

I wouldn't pool 3 different revision data from 3/4/5 into one single bucket as 22 guys. We cannot add the high risk of worser groups (4/5) to the lower risk of 3rd group unless the risk is uniform across all.

I think these percentage numbers (Ex: 2 patients and 100% risk) are like the monthly MAUDE statistics, they are only signal givers and hypothesis generators, but laden with lower quality statistical power from "lack of" or underpowered denominators.

As Dan said, by choosing a good surgeon, we bring down all risks to a lower number, as best as possible.

[Discovernew]

I wouldn't pool 3 different revision data from 3/4/5 into one single bucket as 22 guys. We cannot add the high risk of worser groups (4/5) to the lower risk of 3rd group unless the risk is uniform across all.

I think these percentage numbers (Ex: 2 patients and 100% risk) are like the monthly MAUDE statistics, they are only signal givers and hypothesis generators, but laden with lower quality statistical power from "lack of" or underpowered denominators.

As Dan said, by choosing a good surgeon, we bring down all risks to a lower number, as best as possible.

Thats why i said 33% OR more. Everyone with more than 3 revisions has more than 33% chance. So 33% is the baseline from there. There are 22 guys with 33% or more chance. The trend in the study seems clear, the higher amount of revisions, the higher chance of infection.

Of course i do hope an updated study will come out with more encouraging numbers than this one. This one seems to be from 2018.

[lasthope2.0]

I wouldn't pool 3 different revision data from 3/4/5 into one single bucket as 22 guys. We cannot add the high risk of worser groups (4/5) to the lower risk of 3rd group unless the risk is uniform across all.

I think these percentage numbers (Ex: 2 patients and 100% risk) are like the monthly MAUDE statistics, they are only signal givers and hypothesis generators, but laden with lower quality statistical power from "lack of" or underpowered denominators.

As Dan said, by choosing a good surgeon, we bring down all risks to a lower number, as best as possible.

Thats why i said 33% OR more. Everyone with more than 3 revisions has more than 33% chance. So 33% is the baseline from there. There are 22 guys with 33% or more chance. The trend in the study seems clear, the higher amount of revisions, the higher chance of infection.

Of course i do hope an updated study will come out with more encouraging numbers than this one. This one seems to be from 2018.

I'd love a newer study with better statistical power. About pooling, if a guy from 2nd group falls again in the 3rd and 4th group, you are adding him multiple times.

There's no problem with the trend. The percentage numbers are problematic due to poor statistical power.

[Discovernew]

I agree about the 2/2, but if you would take everyone starting from the 3rd revision and above, it would be 22 guys and chance would still be more than 33%, which is huge.

The 3rd revision study with 33.3% rate is still powered only by 12 guys, so from a statistical standpoint the study is still highly underpowered.

For surgeons, this study can be useful in a medico-legal setting because it bolsters the argument that infections in such settings are driven by the number of prior revisions rather than surgical error!

I’m on my second revision, and my surgeon explained that the risk of infection roughly doubles with each subsequent surgery, with the initial implant carrying a risk of about 0.5–1%.

Hi Jsmith, i was looking at your signature. I see you changed from a rigicon X to AX. I am curious what was the reason for the change? and did you gain any size after changing to AX, or did it remain the same as before?

[Oz1958]

What a storm in a teacup.
I dont know how anyone could even be allowed to publish such a worthless study.
Just look at the numbers.

"surgery between 2013 and 2015"
So the report is 10 years old, has there been no progress in 10 years?

"We identified 44 patients with at least one prior IPP presenting for consultation."
There are only 44 patients, so some are counted twice, thrice or more.

"There were 88 IPPs placed"
In 3 years? Average less than 30 per year. If revisions are as common as everyone is worried about, surely any high volume surgeon is going to be doing that on their own.

BUT

"by 28 different surgeons"
So that's one revision per surgeon per year.

EITHER
The study is being very selective on patients, what about the hundreds of other patients those 28 surgeons saw in that 3 year period.

OR
They are very low volume surgeons, and there are plenty of other studies that show infection rates fall off a cliff for surgeons performing about 30 implants per year.

Don't think I'm in the least concerned about any of this report

[Chris1967]

It's not as bad as the statistics make it out to be. Find a good surgeon with a high volume of procedures and be in good health for the revision. Diabetics should be well-controlled. Exercise, limit sugar and alcohol. Ideally, don't smoke at all! Then your risk of infection is very low. I'm having my first Rigicon AX Infos Pulse implant done by Professor Dr. Osmonov in January. He told me about a patient who's already had seven revisions and never had an infection. The revision is easier for the surgeon than the initial operation. If you have a good doctor, don't worry, just enjoy life and your bionic abilities. Statistics don't reflect reality!

[Discovernew]

It's not as bad as the statistics make it out to be. Find a good surgeon with a high volume of procedures and be in good health for the revision. Diabetics should be well-controlled. Exercise, limit sugar and alcohol. Ideally, don't smoke at all! Then your risk of infection is very low. I'm having my first Rigicon AX Infos Pulse implant done by Professor Dr. Osmonov in January. He told me about a patient who's already had seven revisions and never had an infection. The revision is easier for the surgeon than the initial operation. If you have a good doctor, don't worry, just enjoy life and your bionic abilities. Statistics don't reflect reality!

Let us know how the AX goes!