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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
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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and Alternative Breast Implants - Draft Guidance for Industry and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
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