Community | November 21, 2009 | 6 comments

FDA ALERT AGAINST X4LABS PENIS ENLARGEMENT EXTENDER WARNING

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Import Refusal ReportRefusal Details as Recorded in OASIS by FDA
for Refusal UPS-5523013-8/1/1/
warning gangeros penis enlargement extender X4labs
Violation Code Section Charge Statement
DIRECTIONS 502(f)(1), 801(a)(3); MISBRANDING The article appears to lack adequate directions for use.
NO PMA 501(f)(1)(B), 801(a)(3); ADULTERATION The article appears to be a class III device without an approved application for premarket approval pursuant to section 515(a).

http://www.accessdata.fda.gov/scripts/ImportRefusals/ir_detail.cfm?EntryId=UPS-5...
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6 comments // FDA ALERT AGAINST X4LABS PENIS ENLARGEMENT EXTENDER WARNING

  • NuMaWei
    • 0
      NuMaWei  
    • Image

    • Levine and most other American MDs are prescribing a medical grade extender device imported by Fastsize LLC of Aliso Viejo (www.fastsizemedical.com) for the treatment of Peyronie's Disease (not penis enlargement). This disease results in curvatures of the penis caused by plaque or injury. A clinical medical trial and subsequent clinical experience has proven that the Fastsize device works (there are many unproven 'knock-offs' on the web).
      Clinical trial subjects and many subsequent patients have reported a side effect of the Peyronie's treatment - thickening and lengthening of the penis! Photo is of Dr. Laurence A. Levine MD, FACS, the highly respected researcher who conducted the first Fastsize Medical Extender trial.

    • 2 years ago
  • Danillo
    • -1
      Danillo  
    • NuMaWei:

      Well, actually I have searched on internet and the information I got about this doctor and Fast size.... is not very good. I am interested in curvature correction and enalrgement if possible and I found several products for this purpose...Fastsize is not a serious company and its products are not safe... I don't trust these products...and I read about it on forum and other articles...It seems you have to be careful regarding penis enlargement. I found one device which holds FDA approval and other certifications worldwide and a lot pf doctors recommend it, it is called andropenis and its manufacturer is andromedical, they seem to be serious I contected them and probably I will buy one andropenis. I contacted Fastsize too just to compare prices but fastsize seemed to be not very professional and very their answers about the qulity and medical certifications were evasive. I don't know if it will work for me but i will try it...I will let you know.

      FYI
      Regards,

    • 2 years ago
  • FalseBlaster
  • FDAalertX4labsWARNING
  • FDAalertX4labsWARNING
    • 0
      FDAalertX4labsWARNING  

    • I have notice of a costumer with side effects, He used this forbidden X4labs device, Dr. Giunta sold this X4labs extender a year ago and now he is with lesions and decreased sensation in the penis, with permanent damage.
      X4labs extender device can cause irritation to the penis, which can result in temporary swelling- eventually leading to permanent damage.

    • 2 years ago
  • FDAalertX4labsWARNING
    • 0
      FDAalertX4labsWARNING  

    • I have notice of a costumer with side effects, He used this forbidden X4labs device, Dr. Giunta sell this X4labs extender a year ago and now he is with lesions and decreased sensation in the penis, with permanent damage.
      X4labs extender device can cause irritation to the penis, which can result in temporary swelling- eventually leading to permanent damage.

    • 2 years ago
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