Skip NavigationFDA Logo links to FDA home pageCenter for Devices and Radiological Health, U.S. Food and Drug AdministrationHHS Logo links to Department of Health and Human Services website

FDA Home Page | CDRH Home Page | Search | CDRH A-Z Index | Contact CDRH U.S. Food and Drug Administration Center for Devices and Radiological Health
horizonal rule

(Picture of a tulip)Breast Implants
        
 

 

FDA Breast Implant Consumer Handbook
2004 Edition

Patient Labeling for Saline-Filled Breast Implants
Mentor Corporation (updated 1/04)
Inamed Corporation (formerly McGhan Medical) (updated 8/02)

Breast Implant Complications
Brochure of Potential Local Complications and Reoperations - 2004
Photographs and/or Illustrations of Breast Implant Complications

 

Breast Implant Studies
Study of Silicone Gel Breast Implant Rupture, Extracapsular Silicone, and Health Status in a Population of Women
Study of Re-operations and Self-Reported Silicone-Gel Breast Implant Rupture (Interview Component)
Study of Rupture of Silicone Gel-filled Breast Implants (MRI Component)
Breast Implant Adverse Events During Mammography

Mentor Information
Mentor Agrees to Comply with FDA Requirements for Breast Implant Manufacturing (FDA Talk Paper 98-24, May 5, 1998)
Questions and Answers about May 5, 1998, Consent Decree concerning Breast Implants made by Mentor Corp.
Mentor Consent Decree Vacated [PDF]

Other Resources
Breast Implant Resource Groups
Breast Implant Listserv
Saline, Silicone Gel, and Alternative Breast Implants - Draft Guidance for Industry and FDA Staff
Press Release for Breast Implants Guidance
MedWatch
FDA Consumer Affairs Staff

   
  We welcome any suggestion for improvement of this breast implant website, including the breast implant consumer handbook and risk brochure. If you are a consumer with questions, please contact the FDA Consumer Affairs Staff.

 

Updated June 9 , 2004

horizonal rule

CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page

Center for Devices and Radiological Health / CDRH