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Devices used to treat erectile dysfunction, including their safety features and potential risks.
Choosing an FDA‑approved penis pump hinges on two things: confirming the device is an FDA‑cleared Class II external penile rigidity device and verifying it has both an automatic vacuum limiter (often ...
FDA‑cleared vacuum erection devices (VEDs) are Class II medical devices designed and regulated to create erections by applying controlled negative pressure to the penis and to be used with a constrict...
FDA classifies external penile rigidity devices — commonly called vacuum erection devices or penis pumps — as Class II medical devices and sets special controls that focus on specific design features ...
FDA‑approved vacuum erection devices (VEDs are Class II medical devices cleared for treating erectile dysfunction and for penile rehabilitation after prostate surgery . They are designed, tested and l...
Vacuum erection devices (VEDs) are an effective, noninvasive option for many men with erectile dysfunction (ED), but there are clear clinical situations in which they are discouraged or require extrem...
Improper use of penis pumps commonly produces superficial injuries — bruising, petechiae (pin‑point bleeding), blistering, numbness and temporary discoloration — and, less frequently, more serious eve...
Randomized trials exist for each modality—PDE5 inhibitors (PDE5i), vacuum erection devices (VED), and intracavernosal injections (ICI)—and several randomized studies and systematic reviews report bene...
Urologists assess anticoagulated patients for procedures by weighing thrombotic risk, bleeding risk of the planned intervention, pharmacology of the agent, and patient factors such as renal function a...
Vacuum erection devices (VEDs) are an effective, non‑invasive treatment for erectile dysfunction and for penile rehabilitation after prostate surgery, but they carry specific risks and clear contraind...
Urologists choose between vacuum erection devices (VEDs), oral phosphodiesterase type 5 (PDE5) inhibitors, and penile implants by matching the patient’s underlying cause of erectile dysfunction (ED), ...
A patient can definitively verify whether a specific vacuum erection device (VED) is FDA‑cleared by locating the device’s 510(k) (K‑number) and confirming that number in the FDA’s official 510(k) data...
Poor glycemic control (higher HbA1c) clearly worsens the underlying vascular and neural damage that causes diabetic erectile dysfunction, and those pathophysiologic changes make mechanical therapies l...
FDA‑cleared vacuum erection devices (VEDs) are medical-grade tools intended and tested for erectile dysfunction and penile rehabilitation and usually include safety features and clear clinical guidanc...