Are bigger size implants at a higher risk of failure?

[FinallyBionic]

I am on FT for about 3 years now. I noticed that we are seeing more failures/issues of big-size implants than small to regular ones. By big I mean 24cm and above, including RTE. Even though these implants are performed by world-class surgeons, we see them happen mostly in less than 2 years. Also, not to forget to mention pump and tubing failures are often the cause.
Would this be one of the reasons that AMS is not producing implants bigger than 24cm?
I am just thinking out loudly and welcome any input, feedback, or opinions.

[on the road of life]

From my ignorance.

There are studies that determine the load resistance of the cylinders both longitudinally and horizontally and both AMS and TITAN. In general, the TITAN cylinders are more resistant than the AMS, most likely due to the material (perhaps for this reason there are no larger sizes), within the TITAN there are differences, for example the 18cm is more resistant than the 22cm, but in the practice, it seems to have no effect on performance in real life. But it seems that the forum has not reported failures or breaks in the cylinders.

There are other points of failure such as the tubes or the connectors, which seem to cause the most problems and it seems that these are not so related to the size of the implant per se.

Perhaps a difficult mixture to determine, of material, size, use, manufacturing process, expertise in surgery, problems in implant placement and luck of having a defective or mishandled tube.

I suppose and I hope that companies document the failures and study them...


Regards

[FinallyBionic]

I agree.
I rarely see cylinders failures in both AMS and Titan. Most of non-surgeon related issues are pump failures in AMS and tubing failures in Titan. I hope there is a study that shows failure rates based on cylinder sizes, so that these issues can be addressed by the manufacturers.

[Flounder]

I am on FT for about 3 years now. I noticed that we are seeing more failures/issues of big-size implants than small to regular ones…..

In Dr. Eid’s publications he calls the tubing and connectors, from the pump to the cylinders, the achilles heel of the Titan Implant. Meaning, if there is a premature failure of a 3pc Titan IPP, it’s most likely going to be a tubing/connection failure. Pumps are the second highest failure rates. AMS is not without pump issues also and other things particularly with their larger sizes.

Titans are available in lengths ranging from 11 cm to 28 cm. There are two reservoir sizes available. 75cc for up to 20 cm implants and 125cc for 22 cm< implants. However the pump and tubing components are the same regardless of the implant & reservoir sizes. A full squeeze (wall to wall) of the Titan pump transfers 3cc of saline to the cylinders, again regardless of implant size.

Obviously smaller implants require less saline and less pumping vs larger sizes to achieve similar levels of firmness. So an XL Titan may require twice the pumps compared to a sm/mid size implant. That extra pumping to fill larger cylinders might also exert more flexing and stress on the tubing. I think your theory, based on your observation of FT posts, has some merits. That said, I’ve read a lot of implant related publications and never saw an independent study concluding that early failure rates of IPP’s are biased towards larger sizes. It’s an interesting theory. Maybe bigger isn’t better when it comes to reliability. Or maybe it’s just a small sample size of posts here on FT.

[FinallyBionic]

Interesting facts, Flounder.
Having the same pump inflating an 18cm and 28 cm cylinders might impact the implant longevity?

[Gt1956]

The problem as I see it is very few men get the whole story after a revision. So how are we to evaluate what failed? My opinion based on just my thinking is that the cylinders & reservoirs are fairly stable & have a simple life. Where as the pump & tubing get literally constant movement from muscles, organs & manual manipulation. Not to forget that the tubing is pinched or clamped pehaps several times while the reservoir is filled. My bet is that the tubing is behind a large percentage of failures.

[frank66665]

The problem as I see it is very few men get the whole story after a revision. So how are we to evaluate what failed? My opinion based on just my thinking is that the cylinders & reservoirs are fairly stable & have a simple life. Where as the pump & tubing get literally constant movement from muscles, organs & manual manipulation. Not to forget that the tubing is pinched or clamped pehaps several times while the reservoir is filled. My bet is that the tubing is behind a large percentage of failures.

Gt1956 excellent reflection, I agree with you, there is nothing left for manufacturers to move and improve the materials of pump pipes and connectors

[Gt1956]

The problem as I see it is very few men get the whole story after a revision. So how are we to evaluate what failed? My opinion based on just my thinking is that the cylinders & reservoirs are fairly stable & have a simple life. Where as the pump & tubing get literally constant movement from muscles, organs & manual manipulation. Not to forget that the tubing is pinched or clamped pehaps several times while the reservoir is filled. My bet is that the tubing is behind a large percentage of failures.

Gt1956 excellent reflection, I agree with you, there is nothing left for manufacturers to move and improve the materials of pump pipes and connectors

I think that for the tubing. Improvements might be tough. If they go to firmer material then bulging will happen. About the same for thicker walled tubing. I guess the walls could be thicker thus making the inside smaller. Trade off would be slower inflation/deflation.
Designing their own clamps to pinch the tubing off while they're working on it might help. Videos that I've seen looks like hemostats are the preferred tool. Trouble is they can be over tightened too easily. My guess is too much tension on the clamps is a bad thing. I've read the AMS installation manual. I do not remember any guidance on clamping of the tubing. Seems a recipe for mistakes.
A sealed system would fix that but the length of the pre connected tubing would be a problem. Too short would need added tubing, too long would lead some surgeons just balling it up & stuffing it in the body. I think we've seen some cases of that happening. Btw, how do they fill or adjust the saline amount in a pre connected implant?
My guess, sadly. Is that the implant makers are aware of the problem & the poor methods to fix it. So as long as the insurance companies don't DEMAND implants with fewer failures. We won't see these little refinements accomplished. Medicare might be a good source for this pressure to come from.
Insurance companies swing a lot of weight in the system. I had a nephew on dialysis 30 years ago. His father told me that the insurance companies all got together & forced some changes in the system to reduce costs. My brother is fairly smart, told me the changes were pretty common sense & didn't hurt the level of care in his opinion.
Sorry for the long post. This is a good topic.

[1380anthony]

I agree.
I rarely see cylinders failures in both AMS and Titan. Most of non-surgeon related issues are pump failures in AMS and tubing failures in Titan. I hope there is a study that shows failure rates based on cylinder sizes, so that these issues can be addressed by the manufacturers.

And still waiting for the issue to be addressed. It's almost 2023 and none of the companies apparently care

[FinallyBionic]

This is a good question GT: How the reservoir is filled with a preconnected implant? Isn't it possible for the manufacturer to pre-fill it a day or two before the procedure? The surgeon would already have an idea about the estimated size of the implant and reservoir.