The FDA wants problems to be reported...

[Guest guest]

The Mentor Corp. says any serious problems should be reported.

Source: http://www.mentorwwllc.com/pdf/FinalInformedConsent.pdf Page 42

" The Food and Drug Administration (FDA) requires that serious injuries (defined

as those that need medical or surgical intervention to prevent permanent damage)

be reported by hospitals if they are aware of the serious injuries. If you

believe that you have experienced one or more serious problems related to your

breast implants, you are encouraged to report the serious problem(s) through

your health professional to the FDA. Although reporting by doctors or other

health professionals is preferred, women may also report any serious problem

directly through FDA's MedWatch voluntary reporting system. You can report by

telephone to 1-800-FDA-1088; by FAX, use Form 3500 to 1-800-FDA-0178;

electronically at http://www.fda.gov/medwatch/index.html; or by mail to MedWatch

Food and Drug Administration, HF-2, 5600 Fishers Lane Rockville, MD 20857-9787.

Keep a copy of the MedWatch form completed by your doctor for your records. The

information reported to MedWatch is entered into databases to be used to follow

safety trends (patterns) of a device and to determine whether further follow-up

of any potential safety issues related to the device is needed. "

Hugs,

M.