FDA Guidelines For Safety - 17 Inches of Mercury (Vacuum Pressure)

Specific talk about pumps: Questions, hints, recommendations, etc.
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niarceel
Posts: 127
Joined: Sat Dec 07, 2019 9:50 pm
Location: Utah, USA

FDA Guidelines For Safety - 17 Inches of Mercury (Vacuum Pressure)

Postby niarceel » Sun Feb 02, 2020 11:37 am

If you read enough documentation and marketing information about VEDs, you will find that safety is a serious concern. The issue/danger is primarily from exceeding (negative) vacuum pressure limits with can damage blood vessels in the penis. (The other primary danger is using them for too long a period of time.)

This document from the U.S. FDA specifies their safety guidelines for VEDs:
https://wayback.archive-it.org/7993/20170403201650/https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm072098.htm

Open the document in a browser and search for "17". You will find this sentence:
Vacuum Level – Vacuum pumps typically draw a vacuum of less than 17 inches of mercury. If the vacuum range of a new device differs substantially from that specification, manufacturers should conduct studies to establish the acceptability of the vacuum drawn by their device.

I encourage everyone who uses a VED to pay attention to this number (17). It is a rational safety limit.
Born 1947. Live in Utah. Married 1995. 5'8". 160 lbs.
Health is very good. ED began from venous leakage (2003).
Used Cialis (2003-2017), penile injections (2018-2019), 4 implants (2020-2021), now have an AMS 700 installed.
Hobbies: Only one, my wife.

young_and_impotent
Posts: 215
Joined: Mon Apr 23, 2018 1:00 pm

Re: FDA Guidelines For Safety - 17 Inches of Mercury (Vacuum Pressure)

Postby young_and_impotent » Sun Feb 02, 2020 12:26 pm

Unfortunately my electric pump is cheap and doesn't have a gauge. It has 3 levels but the lowest level is pretty intense. I barely last 2 mins and then have to let the air off. I press the relief valve at last 7-8 times in 5 mins. It seems like the pressure keeps increasing.
28 year old with severe lifelong ED.
Implanted in New Delhi on 26/12/19 with AMS CX (15x12) + 4cm RTE
Post op length 4.5 inches from ~ (5.5 to 6) inches. Disappointed!
Wish to have a revision to LGX some day.

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niarceel
Posts: 127
Joined: Sat Dec 07, 2019 9:50 pm
Location: Utah, USA

Re: FDA Guidelines For Safety - 17 Inches of Mercury (Vacuum Pressure)

Postby niarceel » Sun Feb 02, 2020 2:06 pm

Since your pump does not have a pressure gauge, you might want to use this rule (a physician recommendation):

Stop increasing vacuum pressure when your penis feels a light stinging sensation.


https://www.franktalk.org/phpBB3/viewtopic.php?f=3&t=9266
https://file.scirp.org/pdf/ASM_2013012514045982.pdf - I strongly recommend that you read this article if you are considering a penile implant.

My personal care physician recommends this dictum: "If it hurts a lot, do it not."
Born 1947. Live in Utah. Married 1995. 5'8". 160 lbs.
Health is very good. ED began from venous leakage (2003).
Used Cialis (2003-2017), penile injections (2018-2019), 4 implants (2020-2021), now have an AMS 700 installed.
Hobbies: Only one, my wife.

dtwarren1942
Posts: 1909
Joined: Wed Oct 27, 2010 7:58 pm
Location: Jersey Shore

Re: FDA Guidelines For Safety - 17 Inches of Mercury (Vacuum Pressure)

Postby dtwarren1942 » Mon Feb 03, 2020 9:03 pm

I have been using a penis pump with a vacuum gauge several times a day for over 10 years. Based on my experience, if you were to subject your dick to a vacuume level of 17 in/hg for more than 10 minutes you’d develop significant bruising and possibleI blood blisters on your glans.

The accepted rule of thumb among “professional” pumpers is to limit time under vacuum to less than 20 minutes and a maximum vacuum level of 5 in/hg.

My recommendation for those without a vacuum gauge, is to pump until you feel slight discomfort and then back off slightly.
Age 81
Diabetic
Pumping
Started Trimix injections 8/'11

thereishope
Posts: 190
Joined: Sat Oct 27, 2018 3:22 am

Re: FDA Guidelines For Safety - 17 Inches of Mercury (Vacuum Pressure)

Postby thereishope » Mon Feb 10, 2020 1:05 am

dtwarren1942 wrote:I have been using a penis pump with a vacuum gauge several times a day for over 10 years. Based on my experience, if you were to subject your dick to a vacuume level of 17 in/hg for more than 10 minutes you’d develop significant bruising and possibleI blood blisters on your glans.

The accepted rule of thumb among “professional” pumpers is to limit time under vacuum to less than 20 minutes and a maximum vacuum level of 5 in/hg.

My recommendation for those without a vacuum gauge, is to pump until you feel slight discomfort and then back off slightly.


Hey dt. thanks for the insight. May i ask how has your penile size been throughout this time? maintained? increased?

dtwarren1942
Posts: 1909
Joined: Wed Oct 27, 2010 7:58 pm
Location: Jersey Shore

Re: FDA Guidelines For Safety - 17 Inches of Mercury (Vacuum Pressure)

Postby dtwarren1942 » Tue Feb 11, 2020 7:19 pm

thereishope wrote:
dtwarren1942 wrote:
Hey dt. thanks for the insight. May i ask how has your penile size been throughout this time? maintained? increased?

During my first four years or so, I gained almost 3/4 inch in erect girth. Over the succeeding years I increased my girth up to a little over one inch - 4.4” to 5.5”.
Age 81
Diabetic
Pumping
Started Trimix injections 8/'11

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niarceel
Posts: 127
Joined: Sat Dec 07, 2019 9:50 pm
Location: Utah, USA

Re: FDA Guidelines For Safety - 17 Inches of Mercury (Vacuum Pressure)

Postby niarceel » Fri Feb 28, 2020 1:37 pm

dtwarren1942 wrote:I have been using a penis pump with a vacuum gauge several times a day for over 10 years. Based on my experience, if you were to subject your dick to a vacuume level of 17 in/hg for more than 10 minutes you’d develop significant bruising and possibleI blood blisters on your glans.

The accepted rule of thumb among “professional” pumpers is to limit time under vacuum to less than 20 minutes and a maximum vacuum level of 5 in/hg.

My recommendation for those without a vacuum gauge, is to pump until you feel slight discomfort and then back off slightly.


With regard to my original post quoting the FDA on 17 in/hg, I strongly recommend that readers follow your recommendations, not what the FDA says is the maximum safe limit.

For all we know, 17+ in/hg might be the threshold for a penis explosion.
Born 1947. Live in Utah. Married 1995. 5'8". 160 lbs.
Health is very good. ED began from venous leakage (2003).
Used Cialis (2003-2017), penile injections (2018-2019), 4 implants (2020-2021), now have an AMS 700 installed.
Hobbies: Only one, my wife.


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