One of the TUBA method criticisms offered by people who do not know much about the method, has been that the "warranty is voided." This error is based on ignorance about the procedure. Even some of the manufacturer's reps have this misconception. The most common misinformation is that "the implants could get damaged by being passed through the endoscope". If someone actually tried to pass an implant through an endoscope, it would certainly damage the implant. But in the actual technique, the implants do not pass through ANY instrument, and in fact the implants do not come in contact with any instrument whatsoever as the technique is now performed. (In the original publication of the technique years ago, the implants were pushed into place by an instrument, but that changed five years ago.) The implants touch nothing but the body's own tissues. Perhaps doctors who have not been trained properly may be doing something wrong here, so all we can do is talk about the current correct technique, and we cannot really focus on what incorrect doctors might be doing.
Less commonly heard is that "using the implant as an expander to open the pocket will damage it". Here too, there is a lack of information and understanding on the part of the speaker. Implants are not used as expanders; that was described as part of the original technique, but that changed about 1993. There may be improperly trained doctors still doing that, perhaps, but that would be a reflection upon those doctors, not upon the technique. A surgeon certified by the American Board of Plastic Surgery, who has been properly trained in the TUBA method, and who has attended meetings and read current publications on the technique, will not be doing anything to justify voiding of any warranty by doing the TUBA method.
To view a copy of the letter from the McGhan Corporation specifically re-affirming that all the warranty programs continue to be valid with the transumbilical approach, click below the image here:
To view a copy of the letter from the Mentor Corporation specifically re-affirming that all the warranty programs continue to be valid with the transumbilical approach, click on the image here:
To view a copy of the letter from the FDA specifically stating that the FDA did not specify in the implant labelling any contraindication, precaution, or warning against transumbilical insertion, rather that the FDA cannot recommend the transumbilical approach because there was no data submitted to them, click on the image here:
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