How to Report Problems With Medical Products to the FDA

Breast implants do not last a lifetime and many women report complications that they did not expect. Many women with breast implants experience implant rupture, capsular contracture, breast or body pain, joint pain and other autoimmune symptoms, mental confusion, rashes, and even cancer of the immune system (ALCL). If you have experienced any of these complications, you could help other women by reporting it to the FDA.

The FDA is responsible for protecting patients and consumers by warning them about the risks of medical products, and taking products off the market if the risks outweigh the benefits.  The main way they gather information about the risks of breast implants (and other types of implants) is when doctors, nurses, and patients report problems through the FDA’s Voluntary MedWatch Report. If the FDA sees that complications are more serious or more frequent than expected, we will urge them to require manufacturers to conduct better research or to pull the product from the market.

You can report any problems caused by your breast implants using this short online form.

You don’t need to remember exactly when the symptoms or complications started, but give an estimate of how long it was after you got your implants.  If you don’t know the exact brand or model of your implant, you should report your problems anyway, but include the brand if you can.  From 2000 to 2015, most breast implants in the US were made  by either Mentor or Allergan (also called Inamed or McGhan).

If you are in Canada, you can report medical device complications to Health Canada using this short online form.

If you prefer to report your problem over the telephone, you can do that by calling the at 1-800-FDA-1088.

If you have problems completing the form, ask for help at info@center4research.org

 

All articles are reviewed and approved by Dr. Diana Zuckerman and other senior staff.