Reporting implant complications

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To report complications (like deflation, contracture,

or additional surgery, as well as illnesses that have

occurred, or worsened, since getting implants) start

by calling MedWatch: 1-800-FDA-1088. Be sure to

explain the problem -- rather than just saying

contracture, describe it in terms of pain, hardness,

or distorted shape, etc.

To expedite getting the form submitted, you can fill

out as much of the form as possible, and ask your

doctor to complete the portion about the adverse

effects due to implants (while you WAIT), then offer

to mail it . . . If you get the runaround, or suspect

that your doctor will not cooperate, fill it out and

send it in yourself!!

Information about MedWatch reporting can be found at:

http://www.fda.gov/cdrh/breastimplants/bimedwat.html

(information about reporting implant problems)

and : http://www.fda.gov/medwatch/index.html (more Med

Watch info)

Unless we report the complications resulting from

breast implants, we cannot expect the FDA to hold the

manufacturer's responsible.

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