If I Experience a Problem, Should I Report It?

Frequently Asked Questions

If you believe that you have experienced a serious problem(s) related to your breast implants, you should have your health professional report the problem(s) to the FDA. You are encouraged to report any adverse events through their health professionals. Although reporting by physicians or other health professionals is preferred, women may also report any serious problem directly through the MedWatch voluntary reporting system. An adverse event is serious and should be reported when it results in an initial or prolonged hospitalization, disability, congenital anomaly, or medical or surgical intervention.

To report, use MedWatch form 3500, which may be obtained through the FDA's website at http://www.fda.gov/medwatch/index.html. You may also call 1-888-463-INFOFDA (1-888-463-6332) from 10:00 a.m.  4:00 p.m. Eastern Time, Monday through Friday, to receive an additional FDA MedWatch package. Keep a copy of the MedWatch form completed by your doctor for your records.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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Breast Reconstruction
About Mastectomy
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A wealth of information about your choices in breast reconstruction.
Frequently Asked Questions
Your frequently asked questions about breast implants and breast reconstruction, answered here.
Mentor Breast Implants
Our full range of gel and saline breast implants, as well as tissue expanders.
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NeoForm is a highly innovative product from a very predictable source.
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For important information on the benefits and risks associated with breast augmentation surgery, read our document called "Important Information for Reconstruction Patients about Mentor MemoryGel™ Silicone Gel-Filled Breast Implants."

You may download a copy of the product package insert "Mentor MemoryGel™ Silicone Gel-Filled Breast Implants", or for saline-filled breast implants "Mentor Saline Filled and Spectrum® Mammary Prostheses."