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Official FDA Penis Pump Warnings

Here are the official FDA warnings and precautions regarding penis pumps:

1. Delayed Diagnosis of Other Conditions

If you have symptoms of erectile dysfunction, i.e., inability to achieve an erection that is sufficient for sexual intercourse, consult your physician prior to using this device to avoid a potentially harmful delay in diagnosing any of the most common causes of this condition, such as diabetes, multiple sclerosis, cirrhosis of the liver, chronic renal failure, or alcoholism.

2. Use with Impaired Pain Perception

Do not use the device if you have decreased sensation of pain in the area of the penis. (This warning should inform the user that if he cannot feel pain, he may not know whether or not he is being injured by the device.)

3. Use with Decreased Hand Strength

Do not use the device if you have decreased hand strength because this may make removal of the device difficult.

4. Alternative Treatments

In addition to vacuum pumps, users can seek alternative treatments for erectile dysfunction or penis enlargement such as counseling, drug therapy, hormonal therapy, vascular surgery, and implanted prosthetic devices. Please contact your physician for more information regarding these alternative treatments.

5. Indications for Use

Follow the instructions and user manual for use of device. Do not use the pump for longer than the recommended duration, typically no more than 20-30 minutes at a time. Overuse can cause tissue damage and bruising.

6. Appropriate Populations for Use

• Men with erectile dysfunction
• Older adults
• Men seeking enhancement
• Men with poor blood flow
• Men with psychological erectile issues

7. Complications

Consult a physician if any complications occur and discontinue use of the device if complications continue.

8. Use of Lubricants

Some lubricants may adversely affect the materials of the device. Please only use water-based lubricants or test the lubricant on the device prior to use.

9. General Warnings

• stop using the vacuum pump if pain occurs
• do not use under the influence of alcohol or drugs, since such use may impair the user’s judgment and increase the risk of injury to the penis.
• do not use if the user has sickle cell disease, has a history of prolonged erections, or is taking large quantities of aspirin or other blood thinners, as these conditions increase the risk of bruising and hematoma.
• misuse of the vacuum pump could injure the penis.

10. Precautions

• apply only the minimum amount of vacuum pressure necessary to achieve an erection; excessive vacuum pressure may bruise or injure the penis.
• use of a vacuum pump may bruise or rupture the blood vessels within the penis or scrotum, resulting in petechiae, hemorrhage, or the formation of a hematoma.
• use of a vacuum pump may aggravate already existing conditions such as Peyronie’s disease (the formation of hardened tissue in the penis that causes pain, curvature, and distortion, usually during erection); priapism (persistent, usually painful erection of the penis as a consequence of disease and not related to sexual arousal); and urethral strictures (urethral stricture is an area of hardened tissue, which narrows the urethra sometimes making it difficult to urinate).
• if appropriate, the labeling should instruct patients not to use an electrically powered vacuum pump in or near water.