Monthly Archives: December 2010

Peyronie’s Disease and Having a Merry Christmas

Posted on by Dr.Herazy

Peyronies is no reason to not enjoy the holiday

Well, we are not far from the big day that is so heavily pushed upon us by commercial interests.   Yet, as we struggle with the burdens life has given to us, it would be good to take comfort in what we learned in our innocent youth about this season of the birth of the  Christ Child.    It might be helpful to the spirit and body to allow your nostalgia to take you back to that time of wonder when anything was possible.  When on a special day at the end of December everything somehow was supposed to be better.   We believed it then, yet over time lost a lot of that expectation to the reality of life.

Do yourself the favor of taking a few minutes to imagine what you would think and how you would feel right now if you had that same youthful enthusiasm for life and for your future.  The child hidden inside you will make you feel good.

You are now attempting to change what has happened to your body, and you are working hard to assist your recovery.  You do not have to feel discouraged or  unhappy.  How you feel inside is your choice.   Realize you have chosen to feel however your attitude  is directed.  If you want to feel like a kid again , it is up to you.  No one can take that from you, and no one can give it to you, but you.

Please stay focused to your PD treatment and let me know if you have any questions or need help in any way.

Merry Christmas to you and to those you love.  Be grateful for all that you have.

TRH

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.

Protection for Peyronie’s Disease during Intercourse

Posted on by Dr.Herazy

Girth enhancement rings stabilize Peyronies

Since 2002 Peyronie’s Disease Institute has made several different products available to our customers that offer important penile protection while still allowing sexual intercourse to take place.   One of these is the girth enhancement ring or sleeve, please see Girth Enhancement Ring.

Using this uncomplicated device provides a level of support that greatly reduces the possibility of re-injury of the penis during intercourse.  For many men this simple and inexpensive device is essential in a couple’s ability to engage in sex at all – for many men the added support is needed to make penetration.

The basic girth enhancement sleeve is a thick but flexible tube that is open at both ends, made of very soft and stretchy silicone material.  The penis is slipped into the tube and the glans or head of the penis sticks out at the other end for full sexual contact.   With this added support the shaft is less likely to be re-injured by sudden bending or collapse.

Even if the cause of Peyronie’s disease in your case was not trauma, it is critical that you do all you can to not injure your penis during sex if you have PD.  The following deformities present a real or potential weakness of the shaft of the penis that can easily get re-injured during sexual activity, and therefore will benefit from the use of girth enhancement sleeve:

1.    Twist

2.    Curve

3.    Bend

4.    Dent, dink, nick, depression, impression or filling error

5.    Bottleneck deformity

6.    Hourglass deformity

Any of these Peyronies deformities is weakest at the area of the greatest distortion, or thinnest part of the shaft, that can suddenly bend, fold or collapse during insertion or while thrusting.  This is the area over which the girth enhancement sleeve should be worn.

Dealing with a penis that is weak in one small area is like having an ankle that is weak because of an earlier injury, making it susceptible to re-injury.   Also, just like a sprained ankle, each penile re-injury occurs more easily and gets progressively worse.  The best approach to take is to not allow additional injury to take place so the tissue remains as healthy and strong as possible.  For the ankle the treatment is to wear a support and to slow down so that you do not hurt yourself again.  The same with Peyronie’s disease.

A valuable second benefit to the girth ring support is the additional thickness or girth it adds to the penis that can make up for the lost dimension that many men experience.

I urge any man whose penis is distorted by Peyronie’s disease – known as a Peyronie’s penis – to investigate the girth enhancement sleeve to provide protection during sexual activity to avoid re-injury and worsening of his problem.

Peyronie’s Treatment and a Crying Baby

Posted on by Dr.Herazy

Peyronie’s disease treatment requires a variable approach

Peyronie’s treatment is a lot like caring for a crying infant.

If you have never had to care for an infant it is necessary to understand that, regardless of what the adult might think about solving the problem of a crying baby, it is the baby who will ultimately determine how a situation is handled and a problem is solved.

The adult might have a certain idea in mind to stop a baby from crying, but to be successful the solution must be in agreement with what is wrong with the baby. It is the baby who will eventually dictate how the problem should be addressed because the baby has needs that must be met, regardless of any adult preconceptions

  • If it is a wet diaper that makes a baby cry, what good is it for the adult to feed the baby?
  • If the baby is frightened, what good is it for the adult to change the baby’s diaper?
  • If the baby wants to eat a lot, what good is it for the adult to feed the baby only a little?

The wise adult will listen to the baby and watch for clues, and act accordingly.

Peyronie’s disease treatment

What was said of the baby is also true of your treatment of the Peyronie’s disease plaque.

  • If you think a high price mechanical penis stretcher will somehow solve your curved penis like straightening out a bent paperclip, I can assure you that your penis is not a paperclip and will not respond like one.
  • If you are convinced that taking vitamin E for a few weeks should help your Peyronie’s problem, but you are actually deficient in MSM, acetyl-L-carnitine, PABA and systemic enzymes, then you will be disappointed.

To be effective, your Peyronie’s treatment must be directed toward what your body needs to heal and repair the Peyronie’s plaque.  In other words, to be successful your Peyronie’s disease treatment philosophy must be correct and directed toward what is actually wrong in your body.

Monitor Peyronie’s plaque to guide treatment

If you know the exact size, shape, density and surface characteristics of each of your PD scars, you will know when your treatment is being effective because one or more of these findings will change as you alter your treatment plan.  Without this exact information about your scar you are only guessing if your treatment plan will work.

For more information about this vital process for successful Peyronie’s disease treatment, go to “Peyronie’s Disease Handbook.”

Causes of Peyronie’s Disease

Posted on by Dr.Herazy

Many possible Peyronie’s causes, few proven ideas

While the cause of Peyronie's disease is not well understood, it is generally thought to be the result of an excessive response to wound healing, or exaggerated internal scar formation at the site of injury.  The traumatic cause of Peyronie’s disease is said to be repeated minor trauma to the penis that occurs during sexual activity; from my experience it is often from significant or major injury during sexual activity in which the penis is suddenly bent during sexual intercourse or during aggressive foreplay of various types.   This type of injury can also occur during a work related or sports accident.

Factors that influence causes of Peyronie's Disease

  • Inherited weakness – a genetic predisposition is thought to exist because Peyronie's disease is seen to be more common in men with family members who also have  PD, or Dupuytren’s contracture, or Ledderhose disease, or systemic lupus erythematosus, (SLE, a connective tissue disorder).   This is supported by a commonly found inherited abnormality of the human leukocyte antigen B27 (HLA-B27).
  • Injury – Peyronie's disease can sometimes start after trauma to the penis in which localized bleeding occurs.   Sufficient injury may happen during  an accident related to sexual intercourse, a medical procedure such as catheterization in which a tube or catheter is passed through the urethra of the penis, or unusual events like falling forward on the ice or even prolonged bicycle riding.
  • Vitamin E deficiency – some evidence this makes Peyronie's disease easier to occur after injury.
  • Drug side-effects – Peyronie’s disease is a rare side effect of blood pressure medications that belong to a group called beta blockers (Inderal).
  • Diabetes – Prolonged diabetes can predispose to damage to the internal lining of blood vessels, including the penis, making either trauma, vitamin E deficiency or genetic factors easier to trigger an occurrence of Peyronie's disease.
  • Infection – When inflammation occurs secondary to an infection it sometimes can spread to the blood vessel walls (vasculitis) causing a reduced blood flow because the response is very similar to a direct trauma to the penis.

Peyronie’s disease and wound healing
Two things you need to know about Peyronie’s penis anatomy is that the penis is made of three long tube-shaped cylinders of tissue – two larger ones called the corpus cavernosae, and one smaller one called the corpus spongiosum; both are filled with a blood-filled type of tissue that resembles a sponge. And the other is that these three tissue structures are wrapped by a layer of tough but delicate tissue called the tunica albuginea.   During sexual arousal or when erection occurs nerve impulses from the higher centers are sent down to chambers signal that they should fill with blood, resulting in the penis being able to expand, straighten and stiffen, causing trouble with sexual activity.

The two corpus cavernosae are surrounded by a sheath of thin elastic tissue called the tunica albuginea, which very slightly stretches during an erection.  During penile injury the tunica can become damaged, causing inflammation.

When Peyronie's disease develops – especially easily in men who are genetically predisposed, but in other men as well when the injury is more significant – normal wound-healing process does not occur because the internal scar tissue becomes excessive.  When this happens the area of the tunica albuginea with the internal scar is no longer flexible and expandable, and the ability to develop an erection in Peyronie’s disease is reduced totally or partially.   When erect, the Peyronie’s penis is distorted and often painful.

For more information, cause of Peyronie’s disease.