Boston Scientific and Coloplast IPP Failure Study

[Wooody]

My doctor helped publish this study recently and thought I'd post it for discussion.

https://pubmed.ncbi.nlm.nih.gov/40197751/

An exerp from the study:

Results: We identified a total of 410 cases: 220 BSCI and 190 CP devices. One hundred twenty-nine were revisions. Seventy-two met the inclusion criteria (63 BSCI and 9 CP). BSCI mechanical failures included: cylinder rupture, 26/63 (41.3%), tubing fracture, 7/63 (11.1%), reservoir rupture, 3/63 (4.8%), cylinder aneurysm, 6/63 (9.5%), and pump failure, 21/63 (33.3%). Coloplast mechanical failure included: tubing fracture 7/9 (77.8%), while reservoir rupture and cylinder aneurysm each were 1/9 (11.1%). Time to mechanical failure was a median of 48 and 41 months, respectively, for BSCI and CP devices.

My doctor told me at my last checkup that Coloplast is planning to change their tubing material to Bioflex, the same material as their cylinders, to reduce their failures. Can anyone else confirm this?

[newhope]

a median of 48 months is pretty low. It means there are 50% of devices that fails within 4 years

[Courage]

a median of 48 months is pretty low. It means there are 50% of devices that fails within 4 years

I assume that's the median for devices that failed within the study period, not the median for all devices installed.

[ElbowRoom]

My doctor told me at my last checkup that Coloplast is planning to change their tubing material to Bioflex, the same material as their cylinders, to reduce their failures. Can anyone else confirm this?

Dr. Hakky told me they are updating the tubing to increase durability, but with FDA approvals and such it was still 3-5 years out.

[ragingbull]

a median of 48 months is pretty low. It means there are 50% of devices that fails within 4 years

I assume that's the median for devices that failed within the study period, not the median for all devices installed.

Yeah they cherry picked these faulty devices...

"A sample is not a sample"...beautiful....whatever makes you sleep at night.

Come on! Let's keep a positive attitude, take every step in life like you own that sidewalk, hold your head high, shoulders back! 50% of these devices are still surviving after 20 years in assisted nursing homes where they're used for non-stop masturbation sessions that'd put porn stars to shame, blush and beg for a timeout!

[wanttokno]

I’ve got to say that looking at my third revision in just eleven years I’m finding this information a bit disheartening but at this point there’s no other real option. Oh well, you do the best that you can with what you’ve got.
Thanks for the post.

[Wooody]

I think we all share the goal of having better reliability of IPP products. As such, I hope that Coloplast does indeed improve their tubing to match the reliability of their cylinders and pumps as this seems to be the weakness of their IPP. Boston Scientific seems to need improvement in more of their components based on this study. Not sure what/if they have any plans for product improvements. Has anyone heard if they are going to make any product changes?

As far as this study goes, it does make sense to exclude surgeries that were the result of infections or other non-product failures such as reservoir migration, mis-sizing etc and only including actual product defects and failures.

[Chris1967]

Hello guys,
If you have a good doctor and treat your implant normally, I think longer periods are feasible. I compare it to a car. If you drive until it's worn out, you'll need repairs sooner than if you drive moderately. If the implant is constantly pumped over 100 percent and used for rough anal sex, it will wear out faster than if you use it normally 3 to 4 times a week for sex. What do you think?

[newhope]

these devices are just hard plastic tubing, they should be bullet proof. The fact that they break within few years imho is a shame

These companies want to make more profit on the behalf of very vulnerable men that can't do anything else. And each revisions increases chances of infections and other terrible outcomes

There should be a class action against these companies

[Chris1967]

Analysis
Long-Term Survival Rates of Inflatable Penile Prostheses: Systematic Review and Meta-Analysis
Larry E Miller et al. Urology. 2022 Aug.
Free article
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Abstract

The purpose of this study was to determine long-term survival of inflatable penile prosthesis (PP) and identify potential factors that may influence device survival. We performed a systematic review of Medline, Embase, and the Cochrane Central Register of Controlled Trials for studies of men treated with inflatable PP with at least 5 years of device survival data. We performed a random effects meta-analysis to estimate device survival at 1, 3, 5, 10, 15, and 20 years of follow-up. The robustness of the meta-analysis results was evaluated in a 1-study removed sensitivity analysis and sources of heterogeneity among studies were investigated with subgroup analysis. In 12 studies (20,161 patients; median age 57 years), PP device survival was 93.3% at 1 year, 91.0% at 3 years, 87.2% at 5 years, 76.8% at 10 years, 63.7% at 15 years, and 52.9% at 20 years. The results of the meta-analysis were not significantly influenced by single study effects in a 1-study removed sensitivity analysis. In a subgroup analysis, 5-year device survival rates were 90.6% vs 82.1% (P = .01) comparing newer vs older studies; no other patient or study design characteristic was statistically associated with device survival rates. In conclusion, the median device survival time of an inflatable PP is approximately 20 years. The factors responsible for improved device survival in newer studies remain unclear and warrant further study.

Copyright © 2022 The Author(s). Published by Elsevier Inc. All rights reserved.

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