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.