July 2025 - IPP Adverse Events

The final frontier. Deciding when, if and how.
LastHope
Posts: 1418
Joined: Sun Feb 18, 2024 1:26 am

July 2025 - IPP Adverse Events

Postby LastHope » Fri Aug 08, 2025 5:49 pm

July 2025 IPP Adverse Events Reported to US FDA

Attached Excel and PDF files

Coloplast Titan - 142
AMS700 - 205
Total - 347
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40, Jan 2025 - Coloplast Genesis 22-13.

ready2go
Posts: 608
Joined: Fri Aug 25, 2023 7:47 pm

Re: July 2025 - IPP Adverse Events

Postby ready2go » Fri Aug 08, 2025 6:37 pm

interesting .
American , retired in the philippines .
tactra malleable 13 mm ,in new delhi India . on april 2024

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tooyoung
Posts: 222
Joined: Sat Feb 01, 2025 12:46 pm

Re: July 2025 - IPP Adverse Events

Postby tooyoung » Sat Aug 09, 2025 6:02 am

LastHope wrote:July 2025 IPP Adverse Events Reported to US FDA

Attached Excel and PDF files

Coloplast Titan - 142
AMS700 - 205
Total - 347


The juicy monthly batch… May God stand by them, because neither the companies nor surgeons are willing to.

Also let’s not forget the ones who weren’t even reported and poor infla 10AX implantees.

wilsonmill
Posts: 443
Joined: Mon Mar 11, 2019 9:50 am
Location: Raleigh NC

Re: July 2025 - IPP Adverse Events

Postby wilsonmill » Sat Aug 09, 2025 7:44 am

Interesting reads, it would be nice if they gave more detail in the writeup, such as which pump was it, who the surgeons were, how long it had been implanted, etc..
Age 64, type 1 diabetic, Married 20+ years, Titan implant 23 cm 27Feb2019, Duke Medical Hospital, Dr Lentz, failed March of 2024, revision 25Jun24 AMS700 LGX 18cm 5rte's Dr Andrew Chang associated urology Raleigh NC, Rex Hospital

LastHope
Posts: 1418
Joined: Sun Feb 18, 2024 1:26 am

Re: July 2025 - IPP Adverse Events

Postby LastHope » Sat Aug 09, 2025 1:57 pm

wilsonmill wrote:Interesting reads, it would be nice if they gave more detail in the writeup, such as which pump was it, who the surgeons were, how long it had been implanted, etc..


I agree, I wish we had more data on these.

I’ve attached a version that includes AMS pump details for some events under the "Brand Name" column. Clicking the Web Address opens the relevant webpage. By comparing the "Date Device Manufactured" and "Initial Date FDA Received", we can estimate the device’s lifespan from factory to explantation.

For example, the attached device most likely lasted 3–4 years (assuming it spent about one year on the shelf after manufacturing).

https://www.accessdata.fda.gov/scripts/ ... uence_no=1
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40, Jan 2025 - Coloplast Genesis 22-13.

LastHope
Posts: 1418
Joined: Sun Feb 18, 2024 1:26 am

Re: July 2025 - IPP Adverse Events

Postby LastHope » Sat Aug 09, 2025 2:21 pm

tooyoung wrote:
LastHope wrote:July 2025 IPP Adverse Events Reported to US FDA

Attached Excel and PDF files

Coloplast Titan - 142
AMS700 - 205
Total - 347


The juicy monthly batch… May God stand by them, because neither the companies nor surgeons are willing to.

Also let’s not forget the ones who weren’t even reported and poor infla 10AX implantees.


Good point. Infla 10AX won't be under FDA's radar until its official FDA approval.
40, Jan 2025 - Coloplast Genesis 22-13.


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