May 2025 - IPP Adverse Event Reports
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LastHope
- Posts: 1329
- Joined: Sun Feb 18, 2024 1:26 am
May 2025 - IPP Adverse Event Reports
I've attached the adverse events reported by surgeons to the FDA for IPPs in the month of May. The file can be viewed in Excel or Google Sheets.
You do not have the required permissions to view the files attached to this post.
40, ED all my life. Pills worked great until they didn't. Jan 2025 Coloplast Genesis malleable. 22cm x 13mm. 1 cm RTE.
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Courage
- Posts: 137
- Joined: Thu Oct 26, 2023 8:51 pm
Re: May 2025 - IPP Adverse Event Reports
Thanks! Didn't know this existed. Found my infection report from March. I'm famous!
Middle-aged SGM with lifelong ED. IPP Implanted January 2025. IPP explanted due to infection February 2025 and replaced with salvage malleable. Looking to get revision.to IPP.
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AussieGuy81
- Posts: 37
- Joined: Sun Apr 13, 2025 12:28 am
Re: May 2025 - IPP Adverse Event Reports
LastHope wrote:I've attached the adverse events reported by surgeons to the FDA for IPPs in the month of May. The file can be viewed in Excel or Google Sheets.
That's pretty crazy, over 200 incidents where basically they all had to be removed
43, ED since late 20's, Pills on and off since then increasing strengths with inconsistent results. Now 5mg Cialis daily and either 20mg Cialis or 100mg Viagra
Not sure if it's Psychological or Physiological, long-term use of SSRI's probably hasn't helped
Not sure if it's Psychological or Physiological, long-term use of SSRI's probably hasn't helped
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Kodixx
- Posts: 335
- Joined: Wed Jan 08, 2025 5:32 pm
Re: May 2025 - IPP Adverse Event Reports
AussieGuy81, maybe -- but when I set the filter to "Malfunction" only, and exclude "Injury", for "Event Type", I only count 14.
- Chuck
- Chuck
AussieGuy81 wrote:That's pretty crazy, over 200 incidents where basically they all had to be removed
Feb 2025 - 58 yo, 38 with greatest wife ever
AMS CX, Tenacio, Dr Broghammer (excellent) - pre-op L:7", post-op @ 3 mo L: 6.75" G: 5.5"
2 wks pain, cycling-sex-lifting @ 7 wks, only minor discomfort @ 10 wks, felt like 'new normal' @ 16 wks
AMS CX, Tenacio, Dr Broghammer (excellent) - pre-op L:7", post-op @ 3 mo L: 6.75" G: 5.5"
2 wks pain, cycling-sex-lifting @ 7 wks, only minor discomfort @ 10 wks, felt like 'new normal' @ 16 wks
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AussieGuy81
- Posts: 37
- Joined: Sun Apr 13, 2025 12:28 am
Re: May 2025 - IPP Adverse Event Reports
Isn't that still a bit odd, 200 people had injuries that caused the failure of their device?.
43, ED since late 20's, Pills on and off since then increasing strengths with inconsistent results. Now 5mg Cialis daily and either 20mg Cialis or 100mg Viagra
Not sure if it's Psychological or Physiological, long-term use of SSRI's probably hasn't helped
Not sure if it's Psychological or Physiological, long-term use of SSRI's probably hasn't helped
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LastHope
- Posts: 1329
- Joined: Sun Feb 18, 2024 1:26 am
Re: May 2025 - IPP Adverse Event Reports
AussieGuy81 wrote:Isn't that still a bit odd, 200 people had injuries that caused the failure of their device?.
Some doctors are reporting mechanical malfunction event as Injury. Attached an example.
I would ignore the event type. We can probably extract better data from Device Problem, Patient Problem and Event Description in the spreadsheet.
You do not have the required permissions to view the files attached to this post.
Last edited by LastHope on Sat Jun 07, 2025 9:15 am, edited 1 time in total.
40, ED all my life. Pills worked great until they didn't. Jan 2025 Coloplast Genesis malleable. 22cm x 13mm. 1 cm RTE.
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Kodixx
- Posts: 335
- Joined: Wed Jan 08, 2025 5:32 pm
Re: May 2025 - IPP Adverse Event Reports
Agreed !
AussieGuy81 wrote:Isn't that still a bit odd, 200 people had injuries that caused the failure of their device?.
Feb 2025 - 58 yo, 38 with greatest wife ever
AMS CX, Tenacio, Dr Broghammer (excellent) - pre-op L:7", post-op @ 3 mo L: 6.75" G: 5.5"
2 wks pain, cycling-sex-lifting @ 7 wks, only minor discomfort @ 10 wks, felt like 'new normal' @ 16 wks
AMS CX, Tenacio, Dr Broghammer (excellent) - pre-op L:7", post-op @ 3 mo L: 6.75" G: 5.5"
2 wks pain, cycling-sex-lifting @ 7 wks, only minor discomfort @ 10 wks, felt like 'new normal' @ 16 wks
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ElbowRoom
- Posts: 235
- Joined: Mon Mar 17, 2025 1:58 pm
Re: May 2025 - IPP Adverse Event Reports
AussieGuy81 wrote:Isn't that still a bit odd, 200 people had injuries that caused the failure of their device?.
Aren't there something like 25,000 IPPs implanted annually? I counted a total of 437 events, which is 1.7% of 25,000...so it seems the overall failure rate is very close to the 2% failures per year we have seen knocked around, if not a bit lower.
What I found interesting is the rate of failures between Titan and AMS were almost identical, within 1 event difference (218 vs 219). They failed for different reasons, but apparently have *exactly* the same reliability.
58yo Coloplast Titan implant scheduled for 10/23/2025 with Dr. Hakky. Pre-op erect measurements:
8.5"L and 6.5"C
8.5"L and 6.5"C
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easymoney
- Posts: 823
- Joined: Tue May 09, 2023 10:28 am
- Location: West Coast Fl.
Re: May 2025 - IPP Adverse Event Reports
what is the website to go to so I can check back and see if my issues have been noted on this list?
Rigicon since 6-2023 happy to share my experience and do show and tell
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Discovernew
- Posts: 896
- Joined: Sat Jul 08, 2023 5:14 pm
Re: May 2025 - IPP Adverse Event Reports
LastHope wrote:I've attached the adverse events reported by surgeons to the FDA for IPPs in the month of May. The file can be viewed in Excel or Google Sheets.
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%).
Implanted October 11, 2024, Dr Karaman. Infla10 AX 20cm +1cm RTE.
My Implant Journal - Click Here
ED about 14 years. Pills worked for 12 years, later worked 50%. Tried almost everything, nothing worked: Shockwave-Testosterone-PRP-Stem Cells-Botox, Etc
My Implant Journal - Click Here
ED about 14 years. Pills worked for 12 years, later worked 50%. Tried almost everything, nothing worked: Shockwave-Testosterone-PRP-Stem Cells-Botox, Etc
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