adverse event reports silicone gel implants' in All of the FDA

January 3, 2008

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Breast Implants - Breast Implant Adverse Events During MammographyAdverse events noted with Breast Implants During Mammographywww.fda.gov/cdrh/breastimplants/b-adverse-events.html - Posted: 04-23-2004 - Cached

Breast Implants - Breast Implant Questions and Answers (2006)Breast Implants - Breast Implant Questions and Answerswww.fda.gov/cdrh/breastimplants/qa2006.html - Posted: 11-17-2006 - Cached

[PDF] November 3,2003 Dockets Management Branch Food and Drug ...... Whether these reports have been ... improve and ensure the accuracy of adverse eventreporting by ... method of assuring the safety of silicone gel-filled breast ... www.fda.gov/ohrms/dockets/dailys/03/Nov03/110603/03p-0511-cp00001-01-vol1.pdf - 12-08-2003 - Text Version

[PDF] November 25,2002 MEDICAL DEVICE REPORTING Federal Register ...... 167 MDRs have been filed by McGhan Medical for their silicone-gel filled breast ... Theadverse event reports for all saline and silicone breast implants ... www.fda.gov/ohrms/dockets/dailys/02/Nov02/112502/02n-0405-c000001-01-vol1.pdf - 12-14-2002 - Text Version[ More results from www.fda.gov/ohrms/dockets/dailys ]

Manufacturer and User Facility Device Experience (MAUDE) Database ...... Event Description. ... This is on the grounds of a) evasive info and failure to takeup reports of implant rupture as adverse incidents as written down ... www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=234767 - Cached

Manufacturer and User Facility Device Experience (MAUDE) Database ...... Dr never told her the mammogram reports stated a contained rupture. ... Type of Device,SILICONE GEL BREAST IMPLANT. ... Is This An Adverse Event Report? No. ... www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=16635 - Cached[ More results from www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM ]

[PDF] 5208 â€˜%3W 16 P2:20... tissues can be induced by silicone breast implants ... Informed Consent stating theirpatients receiving gel-filled ... The adverse event reports of 115,920 are full of ... www.fda.gov/ohrms/dockets/dockets/98n0339/98n339r/c000001.pdf - 09-18-1998 - Text Version

[PDF] MENTOR MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS... For specific adverse event rates/outcomes for Mentor implants ... There have been reportsof silicone presence in ... Movement of silicone gel material to lymph nodes ... www.fda.gov/cdrh/pdf3/p030053c.pdf - 11-17-2006 - Text Version

[PDF] MENTOR SILICONE GEL-FILLED BREAST IMPLANTS... First Occurrence Kaplan-Meier Adverse Event Risk Rates ... maternal silicone breast implantsand adverse health outcomes ... Study: Number of Confirmed Reports of CTD ... www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4101b1_tab-3_01_mentor-insert%20Labeling.pdf - 04-06-2005 - Text Version

[PDF] Guidance for Saline, Silicone Gel, and Alternative Breast Implants ...... the compounds will produce, significant adverse effects ... Complete reports of thepreclinical testing should ... This testing pertains only to silicone gel-filled and ... www.fda.gov/ohrms/dockets/98fr/994003gd.pdf - 08-09-2001 - Text Version

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January 3, 2008