If you’re a man looking for erectile dysfunction (ED) solutions, there are many drugs, herbal supplements, devices, and therapeutic treatments to choose from. So many commercials portray simple ED remedies and seemingly happy couples. With these various choices, which are legitimate medical treatments?
Endorsements and product promotions can be unclear. Some seem intentionally confusing. The lines that separate medical treatments and lifestyle enhancement products are often unclear. Have you ever questioned an herbal supplement advertisement that had the appearance of a legitimate medical treatment?
This is partly how herbal supplements and novelty products are passed off as effective medical treatments. Furthermore, many men don’t discuss the topic of erectile dysfunction with a partner. As a result, fundamental communication about the condition of erectile dysfunction and effective treatment results are not transparent. This creates gaps between perception and reality.
Numerous promoters of pills, gels, drinks, pumps, and herbal supplements put a Young man on a clever label claiming rock hard erections. A normal guy with ED who tries this kind of product may internalize a bad experience with a gimmicky lifestyle enhancement product as a personal or medical failure. He may or may not share his experience.
Medical grade penis pumps are one of the most effective ED treatments available. There are over 800 clinical studies published on medical penis pumps. What is the difference between a medical grade penis pump and one that is non-medical?
Is your penis pump approved by the FDA?
Did you know that any penis pump (vacuum erection device) that makes a medical claim such as treating erectile dysfunction should be registered with the FDA? Unfortunately, many manufacturers do not register and this is not visible to consumers.
In the United States, the Food and Drug Administration (FDA) requires external penile rigidity devices (also known as penis pumps) to comply with Class II Special Controls. All mechanical, powered, and pneumatic devices that are designed to create or maintain erections sufficiently strong for sexual intercourse must comply with certain design and safety features.
This means that manufacturers of medical penis pumps must follow certain standards and recommendations before commercially distributing their device and marketing it to the public. In addition, the FDA recommends certain measures to mitigate known risks and ensure the safe use of penis pumps with best results. For the consumer, this provides an assurance of safety and effectiveness.
The safest penis pump is a medical grade penis pump
Manufacturers of medical grade penis pumps are subject to routine FDA inspections to ensure quality standards are being followed. These standards make a penis pump safe to use. Manufacturers must establish and follow quality systems to help ensure that their products consistently meet applicable requirements and specifications. These are known as current good manufacturing practices (CMPG’s).
According to FDA guidelines, medical penis pumps must have safety-related design features, some of which include:
- A manual safety mechanism to allow quick release of vacuum pressure.
- No feature that promotes extended or continuous use beyond the recommended time.
- A safety valve to ensure vacuum pressure remains within safe levels.
- Smooth shape and surface to minimize potential injury to the user and their partner.
- Adequate electrical safety in powered devices.
- Easy-to-understand instructions with illustrations on how to operate the device.
- Warning statements and consequences of not following instructions on proper use.
Knowing that the device purchased is an FDA-Registered medical penis pump should answer an important question. Are penis pumps safe? This level of adherence to standards and quality commitment is designed to prevent injury and ensure both the user and their partner achieve predictable and reliable results. Read our guide to penis pumps for more information on using these devices correctly and the benefits that can be expected.
Medical grade penis pumps are the most effective in treating ED
Even though FDA requirements are crystal clear about registration and quality standards, many products manufacturers do not comply with good manufacturing practices (GMP). Multiple devices that are misbranded as able to treat erectile dysfunction are available online, in novelty sex shops and some may even be in drug stores. Some of them are not safe.
Others do not offer the correct pressure and features needed to effectively treat erectile dysfunction. By purchasing these novelty devices (which are essentially just sex toys), the consumer is at risk of injury to themselves and their partner. In addition, these novelty toys may also not produce the expected results in men with erection problems. On the other hand, manufacturers of medical penis pumps are committed to aligning their product with consumer expectations without compromising on safety. This means the user is assured of a certain standard in quality, effectiveness, and safety.
When used correctly, a medical grade penis pump provides erections on demand for up to 30 minutes. These devices are recommended by physicians before and after prostate surgery for penile rehabilitation. They are a noninvasive treatment option if someone does not wish to undergo penile implant surgery.
Some men may wonder – is Viagra safe with high blood pressure? Penis pumps are associated with fewer adverse health risks in men taking high blood pressure medications. They are an effective alternative when oral ED medications such as Viagra and Cialis are not an option.
Medicare no longer covers medical vacuum therapy devices
In 2015, Medicare stopped covering vacuum erection devices. During the past few years, most private insurance carriers have followed the example set by Medicare and phased out insurance coverage for erectile dysfunction pumps. Although unfortunate, this is not different from the coverage of oral ED medications. Drugs for sexual impotence, such as Viagra, have been labeled “lifestyle” drugs and are not covered by Medicare or most private insurance.
Many physicians and men seeking ED solutions are reporting a sharp rise in the availability and visibility of non-medical “sex toys” making medical claims following the decision by Medicare and private insurance companies to discontinue coverage of medical vacuum therapy devices.
Aside from this phenomenon, men with erectile dysfunction must pay out-of-pocket for treatment of erectile dysfunction. Options include oral medications such as Viagra that work by increasing blood flow to the penis. However, these may not be effective or may cause side effects. Also, they can cost up to $50 per pill.
Penile implant surgery is not only invasive but also expensive, costing up to $20,000. Which means medical penis pumps are the most cost-effective treatment for erectile dysfunction. These devices are less expensive in the long run compared to medications and other treatments. They can be used repeatedly with few recurring costs.
Always buy a medical penis pump from a reputable company
The founders of Augusta Medical Systems spent over 35 years working directly with prescribing physicians, product users, and clinical educators worldwide. Since 2004 Augusta Medical Systems has offered the discerning customer the very best in vacuum therapy technology.
Our unwavering commitment to quality and continued focus on improving and refining our products has enabled us to maintain a leadership position in the industry. There are several advantages to buying erectile dysfunction pumps from a reputable company like Augusta Medical Systems.
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