How to Report Problems with Medical Products to FDA

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From: CPR for Women & Families

November 2001How to Report Problems with Medical Products to the FDA

Every year, tens of thousands of consumers suspect that their medicines or medical devices might be causing unexpected side effects. Side effects -- also called adverse reactions -- can be quite minor, such as a rash or stomach upset, or very serious, such as mental confusion, heart damage, or an autoimmune reaction. It is sometimes difficult to tell if the health problem is caused by the medical product, or is merely a coincidence. That is why serious problems that are possibly related to a medical product should be reported to your physician and to the Food and Drug Administration (FDA). You don’t have to be certain that the health problem is caused by the medical product -- the purpose of a tracking program is to figure that out by looking at the pattern of reports. By tracking these reports, the FDA can determine if there is a pattern that may indicate the need to warn consumers or even to withdraw a product from the market.

The FDA has a program called MedWatch for reporting serious reactions and problems with medical products, including drugs and implanted devices.

The process is relatively simple and is outlined on the MedWatch website. You may ask your doctor to fill out a MedWatch form detailing the problem you have been experiencing. The MedWatch form is available online, or you or your doctor can request a copy of the form by calling the FDA toll free at 888-INFO-FDA (888-463-6332).

If for one reason or another you do not wish to have the form filled out by your doctor or your doctor refuses to fill out the form (most but not all doctors are required by law to complete a report to the FDA), then you can complete the form yourself. MedWatch provides a set of instructions for completing the form on their website, and they even provide an online form that you can submit directly through the internet.

For those of you who prefer to report your problem over the telephone, you can do so by calling the FDA Office of Emergency Operations at 301-443-1240. If you have some questions about a specific drug or medical device, you can call the FDA toll free information number at 888-INFO-FDA (the same number at which you can request report forms)

ALL Breast Implant Survivors MUST Complete a MEDWATCH Form for the Benefit of ALL! mm

Martha Murdock, DirectorNational Silicone Implant Foundation | Dallas Headquarters"Supporting Survivors of Medical Implant Devices"4416 Willow LaneDallas, TX 75244-7537