Coloplast Titan Mechanical Malfunctions - January 2026 Updates from MAUDE DB

[lasthope2.0]

Events Analyzed = 71/122

Explanted for Mechanical Malfunction:
Max - 20 years
Mean - 5 years
Median - 4 years

<= 1 year 20%
2-5 years 42%
6-10 years 25%
11-15 years 8%
16-20 years 4%

https://www.fda.gov/medical-devices/med ... data-files

[ready2go]

Events Analyzed = 71/122

Explanted for Mechanical Malfunction:
Max - 20 years
Mean - 5 years
Median - 4 years

<= 1 year 20%
2-5 years 42%
6-10 years 25%
11-15 years 8%
16-20 years 4%

https://www.fda.gov/medical-devices/med ... data-files

so close to 50% within 2-5 years , not very good ,considering the expense and the surgery/ recovery time

[lasthope2.0]

Events Analyzed = 71/122

Explanted for Mechanical Malfunction:
Max - 20 years
Mean - 5 years
Median - 4 years

<= 1 year 20%
2-5 years 42%
6-10 years 25%
11-15 years 8%
16-20 years 4%

https://www.fda.gov/medical-devices/med ... data-files

so close to 50% within 2-5 years , not very good ,considering the expense and the surgery/ recovery time

One argument is that these are only for malfunctioned implants. For hip, knee, breast, and dental implants, there are registries of surviving implants. We need a registry for surviving dick implants. I have no doubt that SMSNA will come up with one.

[Kodixx]

lasthope2.0, thanks again for sending this out. Given that hundreds of thousands of these are implanted over 10-20 years, the number of failures seems really small -- or am I missing something ?

- Chuck

Events Analyzed = 71/122

[vincentmh]

Events Analyzed = 71/122

Explanted for Mechanical Malfunction:
Max - 20 years
Mean - 5 years
Median - 4 years

<= 1 year 20%
2-5 years 42%
6-10 years 25%
11-15 years 8%
16-20 years 4%

https://www.fda.gov/medical-devices/med ... data-files

dam, where does come the famous 10-15 years average ?

[lasthope2.0]

lasthope2.0, thanks again for sending this out. Given that hundreds of thousands of these are implanted over 10-20 years, the number of failures seems really small -- or am I missing something ?

- Chuck

Events Analyzed = 71/122

You right, Chuck. Hopefully these are only a few lemons among the thousands that are thriving. I was surprised to see someone get 20 years out of it.

[lasthope2.0]

Events Analyzed = 71/122

Explanted for Mechanical Malfunction:
Max - 20 years
Mean - 5 years
Median - 4 years

<= 1 year 20%
2-5 years 42%
6-10 years 25%
11-15 years 8%
16-20 years 4%

https://www.fda.gov/medical-devices/med ... data-files

dam, where does come the famous 10-15 years average ?

It does seem to be highly random. I saw tubing fractures in 2 years and all the way up to 18 years. Hopefully it's just a tiny quiver among thousands.

[vincentmh]

Events Analyzed = 71/122

Explanted for Mechanical Malfunction:
Max - 20 years
Mean - 5 years
Median - 4 years

<= 1 year 20%
2-5 years 42%
6-10 years 25%
11-15 years 8%
16-20 years 4%

https://www.fda.gov/medical-devices/med ... data-files

dam, where does come the famous 10-15 years average ?

It does seem to be highly random. I saw tubing fractures in 2 years and all the way up to 18 years. Hopefully it's just a tiny quiver among thousands.

well i guess people that make it over 10 years are barely using it like 1 times per week in average. ?

[lasthope2.0]

dam, where does come the famous 10-15 years average ?

It does seem to be highly random. I saw tubing fractures in 2 years and all the way up to 18 years. Hopefully it's just a tiny quiver among thousands.

well i guess people that make it over 10 years are barely using it like 1 times per week in average. ?

Titan Bioflex cylinders are bulletproof. The silicone tubes will rub against each other and wear out, even if we maintain celibacy.

[vincentmh]

It does seem to be highly random. I saw tubing fractures in 2 years and all the way up to 18 years. Hopefully it's just a tiny quiver among thousands.

well i guess people that make it over 10 years are barely using it like 1 times per week in average. ?

Titan Bioflex cylinders are bulletproof. The silicone tubes will rub against each other and wear out, even if we maintain celibacy.

i dont understand your answer, first you say they are bulletproof, then you say it will wear out even without utilisation ?