Tag Archives: extender

Penis Stretcher: Big problem as Peyronie’s Treatment

Posted on by Dr.Herazy

Question safety and effectiveness of mechanical penis stretcher

I closely monitor all aspects of Peyronie’s disease treatment.  On July 27, 2010, I received the following news release from the Food and Drug Administration.  This information is of vital importance to any man who has Peyronie’s disease and has considered using a mechanical penis stretcher for this curved penis problem.

Please carefully read the last sentence of the last paragraph of the FDA release since I will discuss that sentence in particular:

News & Events

FDA NEWS RELEASE

For Immediate Release: July 27, 2010
Media Inquiries: Erica Jefferson, 301-796-4988
Consumer Inquiries: 888-INFO-FDA

Federal Agents Seize FastSize Extenders and FastSize EQM Erectile Quality Monitors
Unapproved devices are adulterated and misbranded; safety and efficacy not established

At the request of the U.S. Food and Drug Administration, U.S. Marshals today seized $346,954.43 worth of FastSize Extender devices and FastSize EQM Erectile Quality Monitor devices, as well as component parts used in the manufacture of the FastSize Extender. The FastSize Extender and the FastSize EQM Erectile Quality Monitor are manufactured and distributed by FastSize, LLC of Aliso Viejo, Calif.

The FastSize Extender and the FastSize EQM Erectile Quality Monitor are misbranded and adulterated because they, among other things, are unapproved and were manufactured under conditions that did not meet current Good Manufacturing Practices (cGMP) requirements. The seizure warrant was issued by the U.S. District Court for the Central District of California.

The FastSize EQM Erectile Quality Monitor device was promoted to measure penile axial rigidity (intercavernosal pressure) and to aid in the diagnosis of health related issues such as diabetes, high blood pressure, and heart disease. The FastSize Extender device was promoted to gain length, girth, and overall penile health improvement and to correct penile deformity caused by Peyronie’s disease. Because the devices are intended to diagnosis, cure, mitigate, treat or prevent diseases, they are subject to the regulatory authority of the FDA. The devices do not have approved applications for premarket approval for these uses.

During a recent inspection of the FastSize LLC manufacturing facility, inspectors noted significant deviations from cGMP regulations. Additionally, the devices are not properly listed with the FDA as required by law, and the firm failed or refused to furnish materials or information regarding the devices to federal inspectors as required under the Medical Device Reporting regulation.

Three important issues come to mind about this penis stretcher:

1.    Seizure of more than a third of a million dollars worth of property is a serious action for the FDA to take.  It indicates they acted in accordance with strong evidence against the FastSize Extender manufacturer to immediately stop any further sales of this product.  This is not just a slap on the wrist over a difference of opinion or a minor offense; this suggests the FDA encountered a major problem with the FastSize Extender.  Perhaps they had reason to think they would not be cooperative or forthright if they were otherwise simply asked to stop selling this device to the public.

2.    Although the news release does not go into detail about the deviations from current Good Manufacturing Practices problems encountered by the FDA inspectors, it could possibly do with sanitation or material and assembly quality issues.  None of this should make anyone feel good who has used this product in the past.

3.    The first sentence of the second paragraph, in which the FDA says. “…The FastSize Extender…are misbranded and adulterated because they, among other things, are unapproved and were manufactured under conditions that did not meet current Good Manufacturing Practices (cGMP) requirements…” caught my interest.  I wanted to know more about what these “other things” might be.  For this reason I called the FDA spokesperson who wrote this FDA news release, Erica Jefferson,  to learn what she did not report concerning these “other things” that were a problem with the FastSize Extender.  I specifically asked her in a telephone conversation about details concerning the safety of this product and what is called efficacy (the ability to produce the desired result) meaning, the ability of the FastSize Extender to reduce the penile curvature of Peyronie’s disease.  In an email on 7-28-10 Ms Jefferson replied to me:

Dear Dr. Herazy,

Thanks for your call. So, I checked in with our compliance folks and as the release points out, the FastSize Extender has no approved application for premarket approval in effect (pursuant to 21 U.S.C. 360e(a) of the Federal Food, Drug, and Cosmetic Act), thus, there is no assurance that the device is safe and effective for its intended uses.

Regards,

Erica

Erica V. Jefferson
Press Officer
Office of Public Affairs
U.S. Food and Drug Administration
office: 301-796-4988
cell:  240-753-3047
fax:  301-847-3536
email: Erica.Jefferson@fda.hhs.gov

So, apparently these “other things” are the fact that in spite of the extensive advertising about how great the FastSize Extender is to treat PD, the manufacturer has no proof that it is safe or effective.  No additional details were available about the safety issues.

If the manufacturer actually had any data or information to prove the FastSize Extender was safe or that it had efficacy (effectiveness) to treat Peyronie’s disease, you can rest assured they would have completed the necessary applications for premarket approval from the FDA.  It is reasonable to assume that they did not complete the required forms because they could not prove the safety or the ability to help treat Peyronie’s disease.

Mechanical penis stretcher not a Peyronie’s treatment

For years now this blog has addressed the problems of these mechanical penis stretching devices.  To read a past blog about this subject, go to Peyronie’s disease and the penis stretcher.   Many men have told me their PD started after they injured themselves with a mechanical penis stretching device; therefore, it does not make sense to me that this same device could actually help PD.

Please keep this FDA news release in mind the next time you see one of those slick ads promoting a mechanical penis stretcher.  It looks like the government is starting to crack down on these folks.

Let me know what you think about this FDA announcement, and let me know your experiences with a mechanical penis stretcher.

Peyronies Treatment and the Penis Stretcher

Posted on by Dr.Herazy

Peyronie's Curved Penis and the Penis Stretcher

This blog report is about the hot Peyronie’s disease treatment topic of penis stretchers, or as they sometimes call an extender, and the long awaited announcement of our new, one-hour PDI Manual Penis Stretching Method© CD video.

All of this work and the discovery of yet another way to use Alternative Medicine to treat Peyronie’s disease started because I receive so many questions about the penis stretching devices, and the sad fact that I hear so many bad stories about them. I got tired of telling people why these penis stretcher devices cannot work, describing the common potential dangers they create, their mechanical limitations of use, and the many horror stories I hear from men whose PD started after using a penis stretcher. So, I started with a goal to learn if I could safely and effectively stretch the Peyronies penis, and I did.

A few months ago I wrote in the PD Institute Newsletters that I would soon offer a process that would revolutionize the concept of penis stretching as an improved form of Peyronies treatment. Now, the brand new PDI Manual Penis Stretching Method© CD is complete and ready for your review on the PDI website.

There are several very good reasons I looked into, and then developed, this entirely new concept in Peyronie’s disease treatment. Most of these reasons are well known to a large percent of men who have Peyronies treatment and have tried and failed with the commonly advertised mechanical penis stretcher devices, and should be well known to the rest of you for your personal benefit and safety.

From my experience, those over-priced penis stretcher devices you see advertised so heavily as a Peyronies treatment are not effective, and are potentially dangerous to all men with PD.

One aspect of the problem is the inability to wear the stretcher. Makers of these manual devices do not mention on their websites that you should not wear the device for more than two hours at a time – yet they want you to wear it for eight to nine hours a day to achieve results. If you could actually wear the stretcher for the full two hours, this would mean that you would put it on and take it off four or five times a day, with perhaps an hour or two rest periods between each wearing cycle. Most of your day would be spent tending to the stretcher, and you would have to do this for perhaps a year or more!

However, after talking to many hundreds of men over the years I know that most men cannot wear one for longer than 10-15 minutes at a time because of the pain and injury they cause. The pain is not so much caused by actual stretching of the penis, but by the pinching and compression to the head of the penis (glans) that is needed to forcefully hold the penis while it is stretched. Now, I don’t know about you, but my penis does not have a handle on it, so there is no good or easy way for a mechanical stretcher to grab the penis in order to stretch it. Thus, it is necessary to apply a strong and constant pressure directly around and below the glans while the traction force is applied.

I have met a few men who could wear a manual stretcher for up to an hour at a time, but not much more than that. If you are one of the men tough enough to wear one for up to an hour, this would mean most of your waking hours would be spent waiting in pain to either put the stretcher on or take it off. I have met men who had so much pain, tissue erosion and broken blood vessels that they never tried to wear it more than once. I have met men whose Peyronies started after a single use of a manual penis stretcher.

The danger of bruising, blisters and tissue erosion are so common that the instructions that come with the stretcher devices discuss what you should do when – not if – these problems occur. If this level of injury happens to the outside of the penis, it can do similar injury to the delicate tunica albuginea where the real injury of Peyronie’s disease occurs. This is how men get into trouble.

There are other practical problems with the stretchers. These involve common issues of daily living like wearing clothes, sitting down, working or urinating that make using a stretcher rather difficult or impossible. I guess these would not be a problem to men who do not wear clothes, do not sit down, do not work, and urinate wherever and whenever they wish. For the rest of us, the mechanical stretchers pose a real problem in the real world.

There are other considerations about the stretcher devices. Have you ever wondered why most of the penis stretcher companies that advertise so heavily are located outside the U.S.? It could be that it is better for them to be located outside the bounds of U.S. law when it comes to customer complaints, product returns and refunds.

Over the years I have been approached by many major manufacturers of these stretching devices, asking me to sell their products on the PDI website. When I ask a few specific questions of these people, something interesting always happens. I find that the person I am speaking to suddenly is not the correct person to answer my kind of question, and I am told that someone else will get back to me with an answer. When I do not get called back by the second person, for fun and curiosity, I call back to speak to the second person. The second person is never available, or is never in the office, and never calls me back. Never, in all the times and all the situations this has happened over the years, has anyone ever answered one of my questions. Remember, these are the people who want me to sell their product, yet this is the kind of help and service I receive. Can you imagine the help and service you would receive if you called with a problem after you spent your money?

Did you ever wonder, if the stretchers worked as quickly and easily as the advertising says they do, why do they have to advertise constantly everywhere you go when you read about PD? There is a reason they are advertised so heavily, and it is not because of effectiveness.

Yet, the concept of stretching soft tissue is interesting since Peyronie’s disease is a soft tissue problem.

So, I recently completed this experimental trial that lasted a little less than two years, in which I worked with 10 men who were customers of PDI and NCMP. From this effort I was able to devise a totally new concept in manually stretching the Peyronies plaque or scar. Our results showed that 80% had moderate to marked reduction of curvature and/or scar formation, with each and every man experiencing an improvement of sexual function.

I encourage you to visit the PDI website to learn more about this method to safely, painlessly, comfortably, and effectively reduce your PD scar, reduce your PD curvature, and improve your sexual ability in 80% of the cases. I ask that you understand that the same concepts of Alternative Medicine, logic and common sense you see throughout the PDI website also applies to the strategy and methods taught in the new PDI one-hour stretching CD.

If, after watching the brief demonstration video, you still have questions about the procedure then just send me an email at info@peyronies-disease-help.com You know I will answer your questions.

Bear in mind that the primary principle behind all PDI treatment concepts has always been synergy, and it always will be. Therefore, you need to understand that the PDI Manual Penis Stretching Method© is not a stand alone method.

Manual penis stretching was used in our tests in conjunction with standard Peyronie’s Disease Institute treatment plans as an additional method to increase synergy of care. No one used just this gentle manual penis stretching technique. In each case, greater progress occurred after using the Peyronie’s Disease Manual Penis Stretching Method© than without it; each man who followed the system saw better progress from his PDI therapy plan after adding the stretching technique. It seems that the PDI Manual Penis Stretching Method© increased effectiveness of our current treatment concept in eight out of 10 in our little study group.

Yes, Peyronies is a lousy problem and I wish I could tell you that this is a magical cure – just like the people who make the mechanical penis stretchers or the herbal products, but I can’t. Effectively treating Peyronie’s disease is still work.

While I can report that 80% of the group saw improvement, that means that 20% did not. I came to learn that those who did not do well with the manual stretching method were those who used very small therapy plans or did not follow their plans faithfully. So, there is room for improvement with this manual Peyronies treatment method. I would hope so. We are just learning how to apply this concept, so it will be necessary to share our insights, experiences and ideas with each other.

Please check it out. I believe you will be impressed and intrigued with the PDI Manual Penis Stretching Method©.

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Peyronies treatment and the penis stretcher

Posted on by Dr.Herazy

Peyronies treatment and the penis stretcher

last longer for men

This blog report is about the hot Peyronie’s disease treatment topic of penis stretchers, or extender, and the long awaited announcement of our new, one-hour PDI Manual Penis Stretching Method© CD video.

All of this work and the discovery of yet another way to use Alternative Medicine to treat Peyronie’s disease started because I receive so many questions about the penis elongating devices, and the sad fact that I hear so many bad stories about them. I got tired of telling people why these mechanical penis stretching devices cannot work, describing the common potential dangers they create, their mechanical limitations of use, and the many horror stories I hear from men whose PD started after using a penis stretcher. So, I started with a goal to learn if I could safely and effectively stretch the Peyronies penis, and I did.

A few months ago I wrote in the PD Institute Newsletters that I would soon offer a process that would revolutionize the concept of penis stretching as an improved form of Peyronies treatment. Now, the brand new PDI Manual Penis Stretching Method© CD is now complete and ready for your review on the PDI website at Manual Penis Stretching Method©

There are several very good reasons I looked into, and then developed, this entirely new concept in Peyronie’s disease treatment. Most of these reasons are well known to a large percent of men who have PD and have tried and failed with the commonly advertised mechanical penis stretcher devices, and should be well known to the rest of you for your personal benefit and safety.

From my experience, those over-priced penis stretcher devices you see advertised so heavily as a Peyronies treatment are not effective, and are potentially dangerous to all men with PD.

One aspect of the problem is the inability to wear the stretcher. Makers of these manual devices do not mention on their websites that you should not wear the device for more than two hours at a time – yet they want you to wear it for eight to nine hours a day to achieve results. If you could actually wear the stretcher for the full two hours, this would mean that you would put it on and take it off four or five times a day, with perhaps an hour or two rest period between each wearing cycle. Most of your day would be spent tending to the stretcher, and you would have to do this for perhaps a year or more!

However, after talking to many hundreds of men over the years I know that most men cannot wear one for longer than 10-15 minutes at a time because of the pain and injury they cause. The pain is not so much caused by actual stretching of the penis, but by the pinching and compression to the head of the penis (glans) that is needed to forcefully hold the penis while it is stretched. Now, I don’t know about you, but my penis does not have a handle on it, so there is no good or easy way for a mechanical stretcher to grab the penis in order to stretch it. Thus, it is necessary to apply a strong and constant pressure directly around and below the glans while the traction force is applied.

I have met a few men who could wear a manual stretcher for up to an hour at a time, but not much more than that. If you are one of the men tough enough to wear one for up to an hour, this would mean most of your waking hours would be spent waiting in pain to either put the stretcher on or take it off. I have met men who had so much pain, tissue erosion and broken blood vessels that they never tried to wear it more than once. I have met men whose PD started after a single use of a manual penis stretcher.

The danger of bruising, blisters and tissue erosion are so common that the instructions that come with the stretcher devices discuss what you should do when – not if – these problems occur. If this level of injury happens to the outside of the penis, it can do similar injury to the delicate tunica albuginea where the real injury of Peyronie’s disease occurs. This is how men get into trouble.

There are other practical problems with the stretchers. These involve common issues of daily living like wearing clothes, sitting down, working or urinating that make using a stretcher rather difficult or impossible. I guess these would not be a problem to men who do not wear clothes, do not sit down, do not work, and urinate wherever and whenever they wish. For the rest of us, the mechanical stretchers pose a real problem in the real world.

There are other considerations about the stretcher devices. Have you ever wondered why most of the penis stretcher companies that advertise so heavily are located outside the U.S.? It could be that it is better for them to be located outside the bounds of U.S. law when it comes to customer complaints, product returns and refunds.

Over the years I have been approached by many major manufacturers of these stretching devices, asking me to sell their products on the PDI website. When I ask a few specific questions of these people, something interesting always happens. I find that the person I am speaking to suddenly is not the correct person to answer my kind of question, and I am told that someone else will get back to me with an answer. When I do not get called back by the second person, for fun and curiosity, I call back to speak to the second person. The second person is never available, or is never in the office, and never calls me back. Never, in all the times and all the situations this has happened over the years, has anyone ever answered one of my questions. Remember, these are the people who want me to sell their product, yet this is the kind of help and service I receive. Can you imagine the help and service you would receive if you called with a problem after you spent your money?

Did you ever wonder, if the stretchers worked as quickly and easily as the advertising says they do, why do they have to advertise constantly everywhere you go when you read about PD? There is a reason they are advertised so heavily, and it is not because of effectiveness.

Yet, the concept of stretching soft tissue is interesting since Peyronie’s disease is a soft tissue problem.

So, I recently completed this experimental trial that lasted a little less than two years, in which I worked with 10 men who were customers of PDI and Natural Complementary Medicine LLC. From this effort I was able to devise a totally new concept in manually stretching the Peyronies plaque or scar. Our results showed that 80% had moderate to marked reduction of curvature and/or scar formation, with each and every man experiencing an improvement of sexual function.

I encourage you to visit the PDI website to learn more about this method to safely, painlessly, comfortably, and effectively reduce your PD scar, reduce your PD curvature, and improve your sexual ability in 80% of the cases. I ask that you understand that the same concepts of Alternative Medicine, logic and common sense you see throughout the PDI website also applies to the strategy and methods taught in the new PDI one-hour stretching CD.

If, after watching the brief demonstration video, you still have questions about the procedure then just send me an email at info@peyronies-disease-help.com You know I will answer your questions.

Bear in mind that the primary principle behind all PDI treatment concepts has always been synergy, and it always will be. Therefore, you need to understand that the PDI Manual Penis Stretching Method© is not a stand alone method.

Manual penis stretching was used in our tests in conjunction with standard PDI treatment plans as an additional method to increase synergy of care. No one used just this gentle manual penis stretching technique. In each case, greater progress occurred after using the Peyronie’s Disease DI Manual Penis Stretching Method© than without it; each man who followed the system saw better progress from his PDI therapy plan after adding the stretching technique. It seems that the PDI Manual Penis Stretching Method© increased effectiveness of our current treatment concept in eight out of 10 in our little study group.

Yes, Peyronies is a lousy problem and I wish I could tell you that this is a magical cure – just like the people who make the mechanical penis stretchers or the herbal products, but I can’t. Effectively treating Peyronie’s disease is still work.

While I can report that 80% of the group saw improvement, that means that 20% did not. I came to learn that those who did not do well with the manual stretching method were those who used very small therapy plans or did not follow their plans faithfully. So, there is room for improvement with this manual Peyronies treatment method. I would hope so. We are just learning how to apply this concept, so it will be necessary to share our insights, experiences and ideas with each other.

Please check it out. I believe you will be impressed and intrigued with the PDI Manual Penis Stretching Method©. Go to Manual Penis Stretching Method© and let me know what you think.

zp8497586rq