June 2025 - 326 IPP adverse events reported to FDA

[LastHope]

Attached.

June 2025 IPP adverse events reported to FDA

AMS - 205
Coloplast - 121
Total - 326

[tooyoung]

Attached.

June 2025 IPP failure events reported to FDA

AMS - 214
Coloplast - 121
Total - 335

Oh another fresh monthly batch of busy fuckers.

Much appreciated man...please keep us updated.

[LastHope]

Attached.

June 2025 IPP failure events reported to FDA

AMS - 214
Coloplast - 121
Total - 335

Oh another fresh monthly batch of busy fuckers.

Much appreciated man...please keep us updated.

Your welcome TooYoung . I updated the file and numbers after removing the 2 piece AMS devices. That's 9 less!

[ready2go]

opps wrong post

[cbinspok]

What are the numbers as percentage . Ie I don’t know who sells the most implants?

[frank66665]

Attached.

June 2025 IPP failure events reported to FDA

AMS - 205
Coloplast - 121
Total - 326

This is a random number. What does 326 failures mean? After how long? On how many plants? Worldwide?

[duke_cicero]

Attached.

June 2025 IPP failure events reported to FDA

AMS - 205
Coloplast - 121
Total - 326

This is a random number. What does 326 failures mean? After how long? On how many plants? Worldwide?

I think it's 326 adverse events, not necessarily failures. Not all of them are device failures, erosions, etc. Not sure if worldwide. On row 42 we see that the pump bulb is too hard for the patient. However, there's a pretty scary one in here on row 16:

"IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED AN IMPLANT PERFORATION THROUGH LEFT CORPORAL BODY. THE DEVICE WAS NOT INFLATING PROPERLY AS CYLINDERS WERE OUTSIDE OF CORPORAL BODY. THE IPP WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS REPORTED."

Cylinders were outside the corporal body??? How do you screw that up?

Also, it should be clear to people that erosion is still very much a possibility with IPPs, despite what folks on this forum constantly claim. And, it even seems to occur more frequently with IPPs than MPPs. Of the 326 adverse events, 18 of them are erosions, which is greater than the total number of adverse events from June 2025 for MPPs (16 total).

[fucked0ne]

Cylinders were outside the corporal body??? How do you screw that up?

Must have been a female surgeon!


That’s a joke, duke.

[LastHope]

Good point, Duke. I just corrected the title to Adverse Events.

I’ve seen very few reports from outside the U.S.

Frank, the web link in the first column of spreadsheet sometimes includes the country, event date and the manufacturing date. For example, if a device was manufactured in August 2020 and experienced a tubing fracture in June 2025, we can confirm it had roughly a 4-5 year lifespan.

About who can report these events:

"The MAUDE* database houses medical device reports submitted to the FDA by mandatory reporters (manufacturers, importers and device user facilities) and voluntary reporters such as health care professionals, patients and consumers."

*MAUDE - Manufacturer and User Facility Device Experience database

[frank66665]

Good point, Duke. I just corrected the title to Adverse Events.

I’ve seen very few reports from outside the U.S.

Frank, the web link in the first column of spreadsheet sometimes includes the country and the manufacturing date. For example, if a device was manufactured in 2020 and experienced a tubing fracture in 2025, we can confirm it had roughly a 4-5 year lifespan.

About who can report these events:

"The MAUDE database houses medical device reports submitted to the FDA by mandatory reporters (manufacturers, importers and device user facilities) and voluntary reporters such as health care professionals, patients and consumers."

good good, because I plan on making mine last 20 years At 80 I think I'll hang up my dick