May 2025 - 359 IPP Adverse Event Reports

[Discovernew]

I still think you have to consider the different between an "Event Type" of "Malfunction" versus "Injury". I'm sure the data isn't perfect, but its the difference between a count of 200+ versus 14.

- Chuck

Hi Chuck, what do you mean by "injury"? In the details is showing "injury" as a tubing leak for example, you can read each one of the cases on its own.

The important thing is that over 200 implants needed to be replaced.

[Kodixx]

Discovernew & tooyoung, well, my bad. When I had the Event Type filter set to Injury only, I read a couple related to problems from bad surgery and/or some kind of physical event. But I just went back and read a lot more, and realize they should have been coded as Malfunction instead of Injury.
Again, mea culpa.

- Chuck

Hi Chuck, what do you mean by "injury"? In the details is showing "injury" as a tubing leak for example, you can read each one of the cases on its own.

[LastHope]

I didn't know such info was available.

Where did you find it? Is this USA-Only?

Based on this report, the majority of malfunctions are Titans (68%).

https://www.accessdata.fda.gov/scripts/ ... search.cfm

I ran a search above for May 2025. I don't think this is USA only. I've seen some reports from Brazil, Canada and Korea as well. Here's an example from Brazil.

https://www.accessdata.fda.gov/scripts/ ... uence_no=1

Thanks. I get the impression that this is a U.S.only thing. First of all, the FDA is a US institution. No other country is required to report to them. And the only brands included in the report are AMS and Coloplast. No Rigicon at all which is popular in other countries

You're right, Discovernew.

Even if few reports are submitted from Korea, Brazil, Canada....I see none from UK, India, Egypt, Australia.....hospitals outside the US are not legally obligated to report adverse events the way US hospitals are by the FDA. So treating this as US based data seems more accurate.

I'm personally interested in Rigicon Infla 10 data, which is still awaiting FDA approval. Once it's approved, I expect adverse events (if any) to appear in the database, since Rigicon is headquartered in Ronkonkoma, New York.

[fucked0ne]

https://www.accessdata.fda.gov/scripts/ ... search.cfm

I ran a search above for May 2025. I don't think this is USA only. I've seen some reports from Brazil, Canada and Korea as well. Here's an example from Brazil.

https://www.accessdata.fda.gov/scripts/ ... uence_no=1

Thanks. I get the impression that this is a U.S.only thing. First of all, the FDA is a US institution. No other country is required to report to them. And the only brands included in the report are AMS and Coloplast. No Rigicon at all which is popular in other countries

You're right, Discovernew.

Even if few reports are submitted from Korea, Brazil, Canada....I see none from UK, India, Egypt, Australia.....hospitals outside the US are not legally obligated to report adverse events the way US hospitals are by the FDA. So treating this as US based data seems more accurate.

I'm personally interested in Rigicon Infla 10 data, which is still awaiting FDA approval. Once it's approved, I expect adverse events (if any) to appear in the database, since Rigicon is headquartered in Ronkonkoma, New York.

I’m sure the Rigicon will perform exactly like the others. I’m sorry, but if your product is just the same design operating under a different brand, I really don’t see the point in it existing. We need actual innovations to what we already have.

[LastHope]

Thanks. I get the impression that this is a U.S.only thing. First of all, the FDA is a US institution. No other country is required to report to them. And the only brands included in the report are AMS and Coloplast. No Rigicon at all which is popular in other countries

You're right, Discovernew.

Even if few reports are submitted from Korea, Brazil, Canada....I see none from UK, India, Egypt, Australia.....hospitals outside the US are not legally obligated to report adverse events the way US hospitals are by the FDA. So treating this as US based data seems more accurate.

I'm personally interested in Rigicon Infla 10 data, which is still awaiting FDA approval. Once it's approved, I expect adverse events (if any) to appear in the database, since Rigicon is headquartered in Ronkonkoma, New York.

I’m sure the Rigicon will perform exactly like the others. I’m sorry, but if your product is just the same design operating under a different brand, I really don’t see the point in it existing. We need actual innovations to what we already have.

You're right, F1. This was also the conclusion of their initial Infla study. I hope Rigicon embraces the Kaizen principle in the years ahead and doesn't settle for the status quo established by Coloplast and AMS.

Conclusions
In the very first safety and efficacy study for the Rigicon Infla10®, this single surgeon series demonstrates high rates of patient satisfaction with appropriate early safety from revision. While very new in the marketplace, the Infla10® IPP shows early comparable efficacy and safety from revision compared to competitive 3-piece devices available for decades.

(008) FIRST SAFETY AND PATIENT SATISFACTION STUDY FOR THE NEW RIGICON INFLA10® INFLATABLE PENILE PROSTHESIS

The Journal of Sexual Medicine, Volume 21, Issue Supplement_6, December 2024, qdae161.008,

https://doi.org/10.1093/jsxmed/qdae161.008

[AussieGuy81]

I think the Rigicon IPP has differed a little bit by offering 4 layer cylinders, I think the other two are 3 layer?, I don't know though
The other thing that Rigicon offer is a lifetime warranty, as far as I know that's more than what the other two are offering

[LastHope]

I think the Rigicon IPP has differed a little bit by offering 4 layer cylinders, I think the other two are 3 layer?, I don't know though
The other thing that Rigicon offer is a lifetime warranty, as far as I know that's more than what the other two are offering

Good point, only time will tell I guess. The lifetime warranty is a great benefit. Beyond mechanical malfunctions, Rigicon also covers for erosion and infection, which is even better. Coloplast used to offer one as well for mechanical issues, but for some reason they changed it to 10 years for implants purchased in the US starting April 1st, 2022.

[Discovernew]

I'd love to see a report like this but separated by doctor. So we could see each doctors real infection rate and real volume (brands know this for sure but they would never release it to the public)

[LastHope]

I've added 141 additional events submitted by Boston Scientific. My bad, I think I had a typo in my original filter that left these out. I fixed it.

Coloplast - 151
Boston Scientific - 208
Total - 359

Attached updated file. If anyone has a data visualization software, we can come up with good visuals to study the patterns.