Saturday, May 4, 2013

IPL Laser Damage and Support Forum - Approaching 580 Members

When will the madness stop? When will doctors who KNOW this is happening have the heart and guts to stand up and speak out?

Doctors at most of the major teaching hospitals such as:

Johns Hopkins
Mass General
Cleveland Clinic
UCLA

have seen members of our forum and ADMITTED what our members claim is happening to them happens often. Yet, not one doctor will go on record nor stand up in court to testify, initiate a study, nor report this to the FDA.

Why? Fear? Peer pressure? Who cares why?

Simply do the right thing, honor your medical oath and stop the damage that happens daily. Save someone the pain and suffering the 577 members of our support forum have suffered.

Sunday, April 24, 2011

FDA MAUDE Database for Adverse Events

This list only goes through 2008...it is staggering...these are adverse events filed surrounding cosmetic devices only (IPL, fractional lasers, VBeam, Co2 lasers, and others)

2002-2004 Adverse Event Filings




http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=553996



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=536602



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=536612



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=535908



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=532729



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=578327



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=517792



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=519796



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=528734



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=509760



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=505557



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=501699



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=502793



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=495989



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=493913



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=491206



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=486961



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=485719



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=485743



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=488193



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=481848



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=480840



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=481072



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=480273



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=477218



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=473530



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=476303



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=471907



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=458619



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=458737



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=454612



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=453913



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=452290



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=447931



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=445421



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=442956



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=441611



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=442043



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=429054



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=420473



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=414279



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=399377



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=399380



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=397304



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=384776



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=381176



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=374922



2005 Adverse Event Filings



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=658495



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=652942



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=652423



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=648770



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=648442



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=648768



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=644955



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=746907



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=696464



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=639427



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=639449



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=639650



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=635221



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=751512



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=633487



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=632241



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=624757



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=623600



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=621127



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=621134



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=621033



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=620321



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=617329



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=617341



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=617080



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=616462



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=617051



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=599881



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=597204



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=590374



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=687099



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=574099



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=575866



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=571677



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=568534



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=371624



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=370332



2006 Adverse Event Filings



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=800624



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=800173



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=799199



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=799221



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=799193



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=799209



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=793737



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=789479



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=793717



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=794803



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=981221



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=796649



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=788039



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=785244



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=782290



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=782242



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=778908



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=781738



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=781070



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=777178



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=777126



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=780957



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=770266



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=769642



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=769673



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=768746



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=768264



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=768870



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=767076



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=858866



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=766642



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=766949



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=764108



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=761892



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=761181



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=766178



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=759038



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=758404



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=776948



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=884232



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=757291



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=754070



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=775320



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=753691



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=754315



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=752110



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=748805



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=752117



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=772839



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=748850



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=751404



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=745908



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=741602



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=737273



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=740029



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=731560



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=728628



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=728776



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=726880



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=727192



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=727519



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=726593



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=726903



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=727577



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=725945



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=724545



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=719577



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=965300



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=716824



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=723810



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=713398



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=713408



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=722656



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=712823



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=712413



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=712918



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=710193



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=708471



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=708186



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=708967



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=709191



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=707183



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=707870



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=710067



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=715634



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=702864



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=702146



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=700948



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=701016



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=700412



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=698473



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=693410



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=693540



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=693546



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=693580



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=692109



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=690912



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=690706



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=689078



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=686785



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=685760



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=974907



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=681980



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=681430



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=681611



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=681313



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=677601



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=677561



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=677574



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=675806



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=675845



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=683605



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=679764



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=679833



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=665567



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=666930



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=663663



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=667132



2007 Adverse Event Filings



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=963816



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=956560



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=956518



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=948012



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=948098



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=831530



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=831547



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=831688



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=831708



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=828058



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=828234



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=829981



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=830380



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=830611



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=830621



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=830631



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=830641



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=914762



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=829869



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=829842



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=829851



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=826316



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=827469



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=824529



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=822836



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=823793



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=821899



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=821927



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=822895



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=814665



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=812920



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=824003



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=810399



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=811085



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=808806



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=806696



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=807764



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=806724



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=806208



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=806217



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=806224



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=806223



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=801627



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=801644



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=801654



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=801666



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=801677



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=801735



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=940298



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=940346



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=938045



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=938132



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=938207



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=935184



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=935256



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=932798



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=930447



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=930469



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=926624



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=928487



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=926158



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=923709



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=923710



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=924523



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=908820



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=909619



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=904168



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=902267



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=890996



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=879757



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=875517



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=871997



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=871998



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=852581



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=851299



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=851301



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=851302



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=851306



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=842104



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=954207



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=844024



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=835237



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=834993



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=840103



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=835033



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=835465



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=834776



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=834634



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=831707



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=829531



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=829916



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=830840



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=830887



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=830907



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=832025



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=913089



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=829146



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=829156



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=831430



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=831512



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=801778



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=801872



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=801917



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=801942



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=804672



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=806241



2008 Adverse Event Filings



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1276469



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1278393



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1271547



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1269843



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1269843



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1258484



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1252368



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1242596



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1244705



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1237827



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1229703



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1225783



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1221989



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1221990



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1220249



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1236812



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1216524



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1204543



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1193755



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1199003



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1200343



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1198932



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1190223



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1200283



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1173327



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1174586



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1080974



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1080972



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1080973



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1081430



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1079068



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1068459



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1067422



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1057554



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1056170



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1063289



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1023731



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1055427



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1052146



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1051604



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1045367



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1040345



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1033977



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1034847



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1031650



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1006203



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1001406



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1001407



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1000364



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=996419



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1002866



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1002868



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1002870



2009 Adverse Event Filings



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1280945



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1285687



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1291444



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1291443



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1288579



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1303344



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1293241



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1352573



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1324592



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1327306



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1330770



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1329996



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1334368



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1341579



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1344305



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1346130



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1345645



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1355806



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1358560



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1350013



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1359146



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1360635



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1364949



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1435534



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1368978



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1370857



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1370589



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Friday, April 22, 2011

New Website Reveals and Exposes IPL and Laser Damage

New website that reveals and exposes the damage caused by IPL (intense pulsed light) and various cosmetic lasers such as fractional lasers, ablative lasers, VBeam, and radio frequency devices. The side effects of IPL and side effects of cosmetic lasers are revealed and exposed:

Please visit the site and post your comments on the Guestbook Tab:

http://www.iplandlaserdamage.com/

Friday, November 19, 2010

MAUDE Adverse Event Database-File A Complaint If You Have Been Harmed By A Cosmetic Medical Device

For those who do not know, the FDA maintains a database for reporting adverse events from the use of any medical device, including cosmetic medical devices. This database is called MAUDE (Manufacturer and User Facility Device Experience). Although this is a terribly flawed system, it is a cosmetic device victim's only means of reporting these FDA approved devices to federal authorities. As it is now, the manufacturers fill out reports themselves and investigate themselves. Sadly, doctors/facilities rarely report adverse events as they should. I would imagine out of fear of a lawsuit or being ignored by the FDA. Nonetheless according to the Archives of Dermatology/VOL 142, FEB 2006" editorial (www.dcwderm.com/arch.pdf)

"it is estimated that only1%-2% of reportable events actually get reported..."

It is important to file an adverse event report if you have been harmed. Once you are on the first page of the form, you can skip this page if you do not wish to leave your information, although it is protected by the HIPPA law. You can file a complaint here:

Click "Begin" Button at This Link To File A Complaint

You may also file an adverse event report by:

telephone at 1-800-FDA-1088

fax at 1-800-FDA-0178

mail to:

MedWatch
The FDA Safety Information and Adverse Event Reporting Program
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20852-9787

From the MedWatch Website:

"MedWatch is the Food and Drug Administration's (FDA) program for reporting serious reactions, product quality problems, therapeutic inequivalence/failure, and product use errors with human medical products, such as drugs and medical devices.

If you think you or someone in your family has experienced a serious reaction to a medical product, you are encouraged to take the reporting form to your doctor. Your health care provider can provide clinical information based on your medical record that can help FDA evaluate your report.


However, we understand that for a variety of reasons, you may not wish to have the form filled out by your health care provider, or your health care provider may choose not to complete the form. Your health care provider is NOT required to report to the FDA. In these situations, you may complete the Online Reporting Form yourself.


You will receive an acknowledgement from FDA after your report is received. You will be personally contacted only if we need additional information.

What the FDA requires regarding Adverse Events from manufacturers:

"Adverse event reporting enables FDA to take corrective action on problem devices and to prevent injury and death by alerting the public when potentially hazardous devices are discovered. Within FDA, the Center for Devices and Radiological Health (CDRH) is responsible for regulating medical devices.


Regulations require device manufacturers to report to FDA (1) within 30 calendar days of acquiring information that reasonably suggests one of their devices may have caused or contributed to a death, serious injury, or malfunction and (2) within 5 working days if an event requires action other than routine maintenance or service to prevent a public health issue. Regulations also require user facilities, such as hospitals and nursing homes, to report deaths to both the manufacturer, if known, and FDA within 10 working days. User facilities must report serious injuries to the manufacturers (or FDA if the manufacturer is unknown) within 10 working days. User facilities must also submit annual reports to FDA of all adverse event reports sent to manufacturers or FDA in the past year.

"Overall, FDA received twice as many adverse event reports for medical devices in 2007 than in 2003; however, some types of reports decreased. Manufacturers, user facilities, and other reporters submitted 72,866 medical device adverse event reports in 2003, which doubled to 150,210 reports in 2007. Manufacturers submitted the vast majority of these reports. Thirty-day reports of death, serious injury, and malfunction accounted for almost all manufacturer reports and drove the overall increase in adverse event reports."

Visit this link to see the adverse event reports filed from 2002-10/2010 regarding cosmetic devices detailing hundreds of adverse events surrounding these devices.

Saturday, August 14, 2010

Lucille Iacovelli

If you have never heard her name then you've probably never researched plastic surgery.

I "met" Lucille several years ago on an Internet forum.  She was posting of the evils of having plastic surgery. We corresponded off and on for several years. While I was not in total agreement with Lucille that all plastic surgery was evil, I always agreed that the way she was treated by the medical community was evil. The harm done to her is beyond the comprehension of most of us. It would take hours to tell her heartbreaking story.

Lucille died on August 2, 2010. She was steadfast in telling her truth, an indomitable spirit. She joined our support forum in late June and posted our blog and forum URL on to her blog. I will do the same for her here today. The posts on our forum were amongst some of the last she left on the Internet.

She spoke her truth. She did what her heart said to do. She did not buckle under and stayed true to herself until the end.

May you have the peace in death that you were not given for the last 10 years, Lucille.

http://www.losingface.net/

Wednesday, August 4, 2010

Stories From Our Support Board

Below is a story from one of our IPL and Laser Damage Support Board members. I have posted this with her permission:

I unfortunately want to document here, on the IPL and Laser Damage blog, that I have suffered more than just fat loss from IPL. I have suffered nerve/muscle damage as well. I trusted this FDA approved machine, administered by a board certified doctor to correct acne scars and stop hair growth on my chin and upper lip. My face was mutilated and my life permanently altered by this device, which I was told and assured was safe, non-invasive.
Whether it be said or proved how many people are being affected or damaged from these devices, each individual life counts and this damage should not be minimized by doctors, the manufacturers or the FDA. The public has the right to know possible side affects that these devices cause before they receive the treatments. Patients are not being told.

Doctors insisted it was impossible for Thermage to melt fat, which was later proven, and now legally must warn patients beforehand. Doctors will tell you it is not possible for fat loss to occur with the IPL, but that is not true. I am proof that it does happen, it happened to me. If you want to trust the  information provided by doctors performing IPL and using other cosmetic devices then do so at your own risk.

The FDA is not enforcing further research or testing to prove our damage, so there is no proof out there that is required to reveal it is happening,other than the stories like mine and so many others on our support board and all over the Internet.  Many have and will continue to be harmed, as long as those affected are dismissed or not heard. It's sad. My intention, please just know, is to make you aware that it is happening and of the possibility that it can happen to you as well. Slim or not, decide if the risk is worth it to you.
If you are reading this and have already been harmed by IPL or other lasers please report it to Erin Brockovich's site, she has a link under "product liability" on her website to collect the data of those harmed. Also, for much more helpful information, insight and support from others harmed and places to go to receive help if damaged, please come to the IPL and Laser Damage support forum to talk more in depth. It is a safe place to help support each other through this and has helped me personally, a great deal.
This laser did not stop after melting through my fat, it kept going...burning from my insides out. I say to any doctor who disagrees. Receive the same treatment as myself, same settings, same temp, same areas and then we can talk from equal experience.
The bottom line is...these lasers and cosmetic devices are penetrating deeper then those who are administering them and selling the treatments claim. Unfortunately until the amount of those harmed proves and outweighs, the false claims, it can and will continue. Please be counted and consider at least joining the The IPL Laser Damage Support forum or writing Erin B so that you, as an individual, can be counted and help prove this damage is occurring. The more stories accumulated in one place, the easier it will be to prove this is happening to many people.
Peace

Monday, June 21, 2010

IPL and Laser Damage Support Board

Our support board has moved to the following URL:

http://iplandlaserdamagesupport.prophpbb.com

Please visit to read the stories of those damaged by government approved cosmetic devices at:

http://iplandlaserdamagesupport.prophpbb.com/

Monday, June 7, 2010

The Damage Continues

The support board continues to have new members, almost weekly. I wish I could say we never have new members and that no one else has been harmed by IPL, Fraxel and other cosmetic devices, but that is not the case. We've saved a few the fate so many have suffered and some have found the support board too late. Doctors still refuse to believe the reports of the support board members, even though most of the stories are eerily the same, if not identical.

We have a new board. Please visit us at:

http://iplandlaserdamagesupport.prophpbb.com/

Link to board (click here)

CNN was considering a story regarding the damage from these devices, but don't know that it will ever come to fruition. There is also another company representative from a red light device maker who has shown interest in helping those harmed by cosmetic medical devices.

If somehow you stumble across this blog and know of a researcher or anyone who has an open mind or might be willing to read the stories posted or help those harmed by these devices, please let me know or point them to the IPL and Laser Damage Support Board where they can read the stories themselves.

Saturday, February 20, 2010

In Memoriam: Angela Walker (AWalk)

Angela Walker was a young woman from Virginia who went in for a simple "Fraxel" treatment and came away damaged for life. She was extremely brave and exposed her pain and suffering for the world to see on realself.com, in hundreds of posts and with pictures of her devastating facial damage. Angela was a beautiful person, inside and out.

You may read her entire story here (in her own words):

http://www.realself.com/review/do-not-do-fraxel-ruined-face-burns

This is Angela's first post from realself:

"Do not let anyone put this laser on your face...I was burned and haven't felt comfortable leaving my home in over a year......At first you may think its ok and you're healing...but the laser goes so deep the real results show later.....NOT PRETTY....

The B/After pics aren't that impressive and its very new...

Stick with tried and true I had better results with peels....

510k FDA is not FDA approved or safe......only says other lasers like it on market.....Don't fall for it....It's all marketing and hype....

WAIT till it's been around longer and they work out the kinks and know how to use it....

Will upload pics later

Updated on Jan 25, 2009:
I had this procedure 2 years ago at a plastic surgeons office who I’ve seen for 9 years for botox resty….I would not recommend it to my worst enemy… It seems you may have improvement at first but it causes DNA damage to the existing cells not destroyed..The negative results damage may not be apparent for months or years…..There is not enough research it was put to market to soon and we are the guinni pigs……Don’t let this laser on your face…They have treatments available with long term studies on all skin types that doctors have more experience using…

Updated on Feb 4, 2009:

To the company, executives and sales reps, who rushed this laser to market before they did correct and responsible studies. Exploited the system ..Your unscrupulous, irresponsible, marketing, advertising, and buying of doctors is inexcusable.

You are the true criminals of society not drug addicts, burglars, adults abused as children or the mentally ill that fill our prisons… You have options yet choose to in danger others for personal gain…

You should know I cry everyday and every time I look in the mirror..Your greed, lack of integrity and irresponsibility has ruined life’s...My son is hurt when I hide in the car to watch his soccer games. My mother is sad when she watches me isolate myself from the things and people I love because I have sores and scars covering my face now...Knowing It hurts them is the worst feeling I've ever experienced....One you are obviously incapable of comprehending since you continue these practices today...It’s pure evil and you should be the ones crying or sitting in prisons.

Today is my birthday..The second one I will spend sad and crying with sores and scars on my face, I feel like a caged animal, my phone is turned off and I wonder if I will ever look normal again…Enjoy a birthday dinner, Cheer on the field at my sons soccer game, Go to lunch with my Mom, Attend parties, Go on vacations, Visit my neighbors or Go out with my friends and family ect ect…..

I hope you read this and I hope you think of us when you enjoy theses simple pleasures you have taken from me and my family…Maybe it will take you a few minutes longer to go to sleep tonight??? One can only wish..

To the Doctors performing this procedure Please Take it seriously learn everything before you put it on a patients face...Start with the person you intend to delegate it to...You took an oath when you became a doctor..We count on you to protect and guide us thru the mish mosh of info and the corrupt FDA..

Everyone has a right to make a living especially after so much education...But never at the expense of another....Do your homework...

Do not listen to sales reps.. Or base your decision on delegating this and profit margins..They take no oath, have no education requirements. If you do you don't deserve the title,trust or respect we give you..

You will quickly become a commodity to greedy executives with half your education Please honor your oath and put pressure on peers to disclose..

If I wanted to get a sales reps opinion I’d talk to a sales rep Not my doctor….

Updated on Apr 2, 2009:

I felt a strong need to update this based on the positive reviews I am seeing 24 hours after the procedure... I thought it was fine 24 hours after and was looking forward to the results..

It's impossible review a treatment 24 hours or even weeks after when the results are not visible for months... While helpful in describing what to expect during treatment they should in no way be taken as a positive result.......

If you read the negative reviews you will notice most are months or years after treatment and are not happy ..They say they look much older or it ruined their skin....At this point you can pretty much determine the final result..

I wanted to make sure people considering this treatment put the appropriate weight on the reviews they read...The length of time after treatment should be taken into consideration when making your decision...As results and complications do not present immediately"
These are Angela's pictures:

Angela, the day before her treatment:





Angela, before her treatment that was done later that day:

Angela, one year after her procedure:

Angela twenty months after procedure:


Angela two years after her procedure:



















































Angela was brave to post these pictures, it was not easy. She told her story to warn others and hopefully save them from the fate that befell her.

Angela passed away last October after spending nearly two years hidden away from the world because of the depression and her self-perceived disfigurement from the Fraxel treatment. God bless her goodness and bravery. May she one day have justice for what happened to her life.

To her mother, son and family, I hope you know she was an inspiration and a heroine for what she did to protect and save others.





Visit the IPL and Laser Damage Support board and read the stories of those damaged by government approved cosmetic devices: http://iplandlaserdamagesupport.prophpbb.com/

Saturday, December 19, 2009

The Pain and Devastation Continues

I have had at least six emails in the last week from new 'victims' of IPL, lasers, and V-Beam. Why isn't someone listening when these people speak of their pain and suffering?

The ONLY thing these people have in common is they have had a laser, IPL or V-Beam treatment within days or a couple of weeks of the on-set of their symptoms. Many of those contacting me lately have complained of systemic problems, involving joint pain, vision problems, and swallowing difficulty.

Many of these victims have had innumerable medical tests all coming back 'normal'. Doctors appear to be looking for a 'specific' disease or problem rather than a correlation between the recent procedure and on-set of symptoms.

A tiny handful of doctors have admitted behind closed doors that they feel the symptoms are because of something (deep burns, high temperature??) that happened during the IPL/laser/V-Beam procedure, but none know what or how. These ARE safe procedures, after all. Aren't they? No, think again. They are anything but safe. These procedures are ruining lives and damaging people forever.

Someone who can make a difference and speak out loudly, please step forward. Someone who can expose these devices and procedures for what they are, please pay attention, care, and be brave enough to take on this cause. Someone, anyone, please help!

To read the stories of victims of government approved cosmetic devices, please visit our support forum at:  http://iplandlaserdamagesupport.prophpbb.com/

Saturday, November 28, 2009

IPL and Facial Fat Loss

How do I know? I've corresponded with 100s of people who've experienced this phenomenon following IPL treatments. Their doctors do not believe them but it happens nonetheless.

Please visit:  http://iplandlaserdamagesupport.prophpbb.com/  or click here

to read the stories of those suffering the horrible outcomes from having had IPL treatments.

Many feel it causes DNA damage than can turn into systemic problems that many are also experiencing.

Blame the FDA for this, the blame is at the feet of this quagmire of complicity with medical device manufacturers and the 501k process.

Wednesday, September 2, 2009

New Information

If you visit the IPL and Laser Support Board at: http://iplandlaserdamagesupport.prophpbb.com/   there is a post "general" concerning a study done at Harvard by the doctors at the Wellman center. This study speaks of "by-stander" damage and DNA damage from 'thermal heating' from laser devices. This study was not intended for the average lay person as the intended audience is other medical professionals, but I feel it speaks volumes of the potential damage that can be done by laser devices.

Wednesday, July 15, 2009

If you have been damaged by laser and do not wish to speak publicly, you can anonymously join the IPL and Laser Damage discussion group. You may email any other member there, once you have joined. There are many stories of others harmed by laser and other cosmetic devices on the board. Here is a link:

http://iplandlaserdamagesupport.prophpbb.com/  or click here

Sunday, March 1, 2009

Some Research Papers on IPL


Intense Pulsed Light or IPL as it is known to most patients was first used in the cosmetic industry for hair removal. It evolved into a tool for facial redness, Rosacea, pigmentation issues and "anti-aging".Light pulses targeted at the hair follicle causing the hair to fall out and prevent further growth.

In ththis diagram, you can see how deep a the light must penetrate to reach the hair follicle to "destroy" it. To me, as I am not medically trained, it looks as though the laser has gone well below where the fat layer is, passing through the fat layer on the way to its target (hair follicle).

How can it be assumed that surrounding layers of fat are not damaged in the "journey"?

From what I have read and in my discussions with those who have experienced fat loss following IPL treatments, our feeling is that the fat layer IS damaged by IPL. IPL treatments for other cosmetic procedures appear to be compromising the blood vessels in the fat layer leading to the "death" of the fat or fat atrophy. If an IPL treatment can kill hair follicles, it seems perfectly logical (to me) that it could damage blood vessels in the fat layer of the skin.

The quote from one study speaks of the oxidative and cumulative damage of IPL.

It appeared in the Archives of Dermatology, Olivier Sorg, PhD; Victor Janer, MD; Christophe Antille, MD; Pierre Carraux; Evelyne Leemans; Elizabeth Masgrau, MD; Jean-Hilaire Saurat, MD; Denis Salomon, MDArch Dermatol. 2007;143(3):363-366Quoting the study:



Conclusions: These preliminary results indicate that IPL, although filtered for wavelengths shorter than 500 nm, can generate oxidative stress, a typical hallmark of UV-A, but does not induce thymine dimers. This emphasizes the need for long-term studies involving IPL before using this technique in a recurrent manner.

The quote below is taken from an article commenting on the above study written by Craig A. Elmets, MD . Published in Journal Watch Dermatology April 13, 2007.

According to the subtitle of Dr. Elmet's article:

Molecular study suggests that we keep an open mind about the long-term safety of IPL therapy.


However, the level of lipid peroxides in IPL-exposed skin was six times as high as in nonirradiated skin and twice as high as in skin exposed to UVA light. Comment: The implication of this study is that IPL treatment may not be without consequences. Although IPL irradiation did not affect thymine dimer production because the light source does not emit in the UV range, it did produce considerable amounts of lipid peroxides, an indicator of oxidative stress. Oxidative stress has been associated with a number of deleterious effects; beyond premature aging of the skin, it has been shown to promote skin cancer in experimental animal models. Although these molecular studies do not necessarily mean that long-term adverse effects will ensue, the results point to our ignorance of IPL’s lasting effects. Many highly effective therapies have had adverse effects that were not fully identified until years after regulatory approval. Until IPL has been in active use for a while longer, continuing
follow-up of patients remains important.

This study speaks of possible DNA damage by IPL.

This study was published in Lasers Surg Med. 2007 Jan;39(1):7.


The study was conducted on mice:
CONCLUSION: The repeated use of high-energy laser and intense pulsed light source did not cause any toxicity in mice. The changes in p16 and PCNA imply that further studies are necessary to consider the implications of repeated exposure to longer wavelength radiation in human skin.
There is no doubt, based on the studies above that IPL has considerable risks. It is now time to acknowledge that the risks go far beyond those found in the studies above and give credence to those who have most definitely experienced fat loss through IPL treatments. Our blog and support forum exist to enlighten and warn others of the dangers of IPL. IPL damage is real, not a myth.

Friday, February 20, 2009

Do You Have Recourse If a Loved One Is Severely Injured or Dies Because of a Defective FDA Approved Medical Device?


According to the Supreme Court, NO . There is no recourse:

http://www.newsinferno.com/archives/4787

An excerpt from the article follows:

From a year ago:
According to The New York Times, both Waxman and Pallone have criticized the Riegel decision. For his part, Pallone said he expects the House Energy and Commerce Committee to hold hearings this session to question whether the FDA. process for approving devices is adequate.

Many consumer advocates also decry the ruling because of the FDA’s poor track record of policing medical device, something that has been well-documented in recent months.
In fact, last month the Government Accountability Office issued a report that criticized the agency for failing to conduct appropriate medical device reviews. Around the same time of FDA scientists wrote then President-elect Obama imploring him to reform the agency, which they characterized as corrupt.
The letter explained that that FDA’s regulation of medical devices was “corrupted and distorted by current FDA managers, thereby placing the American people at risk.” The letter also provided specifics about how scientists who differed in opinion from FDA management were threatened with disciplinary action.

“Consumers face the worse of all possible worlds,” David C. Vladeck, a professor at Georgetown University Law Center and a medical industry watchdog, told the Times.
“The FDA has shown itself incapable of keeping dangerous products off the market, and now the Supreme Court has said patients can’t sue companies for redress.”


http://www.nytimes.com/2008/02/21/washington/21device.html

Your child, mother, father, or grandparents could literally have a known defective lead from a Medtronics implantable defibrillator and die or be severely injured from the defect device and you have no recourse.

This is a travesty and the law MUST BE CHANGED!


Medtronic and the Bush Administration asserted that allowing state personal injury lawsuits against the makers of defective medical devices amounts to a state “requirement” different from FDA requirements because such complaints are based on state laws. Eight members of the high court agreed with Medtronic. The Court recently heard another case, Wyeth vs. Levine, that could extend a similar lawsuit shield to drug makers.



There is renewed effort to overturn one of the Bush era tragedies (his staunch support that medical device manufacturers cannot be sued), please read here:

http://www.yourlawyer.com/articles/read/16018

I have no affiliation with the website above and used it only for the purpose of displaying the updated information regarding efforts to overturn the law.

Some in Congress are seeking to do just that. According to The Minneapolis Star Tribune, Rep. Henry Waxman, D- Calif. and Rep. Frank Pallone Jr., D-N.J., plan to introduce legislation that would ov turn the Supreme Court's Riegel ruling. The Supreme Court decision "left consumers without any ability to get compensation for injuries caused by certain defective medical devices,'' Waxman said in a statement to the Star Tribune.
"The Supreme Court assumed that FDA approval ensures medical devices are safe, but the many recent stories of patients harmed by faulty devices have proven that assumption false."
According to the Star Tribune, the Supreme Court ruling covers Class III medical devices, such as implantable defibrillators, which are theoretically subject to the greatest level of scrutiny by the FDA before they are approved.

But lawyers representing Sprint Fidelis victims argue that the lead was not subjected to the same level of clinical scrutiny as other Class III devices because its application piggybacked an earlier Medtronic lead approved by the agency, the Star Tribune said.




It does not stop there, the FDA is rife with corruption! From the New York Times in mid-January, excerpts from the article are below:

http://www.nytimes.com/2009/01/28/us/28fda.html?_r=1&emc=tnt&tntemail0=y



But the accountability investigators found that the agency still allowed manufacturers of most Class III devices to gain approval without conducting extensive testing. Part of the reason may be that some Class III devices should be reclassified as Class II devices, while other such devices simply should be tested more.Critics have long bemoaned the agency’s device approval process, which allows most devices to be approved with minimal testing. Manufacturers say the agency is already overly restrictive.

Of course they (manufacturers) feel they are "over regulated", they want these devices on the market as soon as possible to make MONEY, they don't care about the safety of the public at large, only the money going in their coffers!!

For these reasons, in the quote above, people are dying, being treated as guinea pigs, seriously injured or even being scarred for life by cosmetic devices that went to market in less than a year!!!!

Here is an excellent editorial written by Dr. Dr. Amy Newburger (published in the Archives of Dermatology/VOL 142, FEB 2006) warning of rush to market medical devices and FDA regulation:

http://www.dcwderm.com/arch.pdf

What can you do? WRITE YOUR CONGRESSMAN!

Find contact information for all members of Congress here:

http://www.conservativeusa.org/mega-cong.htm

Sign this petition to Congress to protect yourself, family and friends:

http://www.rallycongress.com/revamp-the-fda/1546/call-to-congress-to-overhaul-fda-medical-device-approval/

To read the stories of those damaged by these FDA approved devices, please visit the support forum:

http://iplandlaserdamagesupport.prophpbb.com/

Tuesday, February 17, 2009

New IPL and Laser Support Board

The IPL and Laser Damage Support Group has a new home:

http://iplandlaserdamagesupport.prophpbb.com/  or click here


Please visit our support group to read the stories of those who have been damaged physically and emotionally by cosmetic devices such as IPL and lasers.

The old board was originally started at Daily Strength, later moved to another forum, but we have now moved to a newer PHPbb message board which offers speed and more features for visitors and members.

Please come read the stories of those damaged by government approved cosmetic devices:

http://iplandlaserdamagesupport.prophpbb.com/

Saturday, February 14, 2009

What Is The Proof?

This is a double edged sword for those who've suffered fat loss or other damage from lasers and IPL devices. The pain of showing that proof is difficult, emotionally. Yet the proof IS the faces of those who've suffered damage from these devices. When confronted, most doctors will not recognize the damage or they will attribute the damage to something/anything other than the device. I'm sure many doctors fear the legal repercussions but most patients want validation that what they are seeing is real, most doctors fear being sued and won't acknowledge it. It's a hamster wheel for victims.

There's little doubt that many have been burned by ablative lasers who's settings were too high. I had unusual damage from an erbium laser that I do not attribute to lack of skill by my doctor, but my own skin's propensity for being sensitive to ablative laser. It's been two years and I have hollowing beneath my eyes, demarcation, small scar beneath one eye and horizontal creasing below my eyes when I smile--none of which were present prior to laser resurfacing.

I am posting links to other websites where people have given reviews or posted their experience with ablative lasers/IPL/RF, many have pictures showing the damage. For me, these pictures speak volumes and are "proof" enough for me:


http://www.realself.com/review/fraxel-laser-horrible (with pictures) A very brave lady who has suffered greatly, physically and emotionally.

http://www.realself.com/review/do-not-do-fraxel-ruined-face-burns (with pictures). Another brave lady who's suffered a great deal as well.

http://www.realself.com/review/ipl-can-cause-serious-burns (pictures included of burns from IPL)

http://www.youtube.com/watch?v=-_VQNm_3NHo (youtube video of lady having fat grafts to correct volume loss from IPL)

http://www.realself.com/review/dents-face-pixel-laser-wrinkles

http://www.realself.com/review/pixel-ruined-eyes

http://www.realself.com/review/fraxel-excruciatingly-painful

http://www.realself.com/review/thermage-face-looks-different-and-older

http://www.realself.com/review/montreal-thermage

http://www.realself.com/review/ipl-ruined-face

http://www.realself.com/review/ipl-sagging-permanent-puffiness

http://www.realself.com/review/laser-resurfacing-side-effects-redness-acne-pores

http://www.realself.com/review/mixto-co2-laser-beware

http://www.realself.com/review/montreal-thermage

http://www.realself.com/review/thermage-london

http://www.realself.com/review/thermage-has-destroyed-my-face.html

http://www.realself.com/review/thermage-made-mess-my-face.html

http://www.realself.com/review/thermage-review/my_thermage_nightmare.html

The "proof" is in the pictures and video.

I could cite forum after forum where these same types of stories exist, but will stop for today.

Please leave comments or leave your story if you have had similar experiences. Our voices should and need to be heard and ring all over the world.

Please read the stories of those damaged by government approved cosmetic devices:

http://iplandlaserdamagesupport.prophpbb.com/

Thursday, February 5, 2009

Fat Loss/Atrophy From Cosmetic Devices

Many who have been damaged by cosmetic devices such as IPL and non-ablative lasers have suffered from fat atrophy, meaning the laser/IPL traveled down to the subcutaneous fat layer and destroyed the cells and compromised the blood vessel supply. While this may not be officially vetted by doctors or scientifically proven, it is the most plausible explanation. On another day, I will point out some interesting information about IPL and the depths of penetration to the skin.

The following blurb is posted on numerous websites all over the Internet with regard to IPL, mostly on manufacturer/distributor and practitioner websites. I cannot list them all, nor note the author as it is unknown to me:
As a photonic "Swiss Army Knife", Intense Pulsed light (IPL) devices have become very popular over the recent past. They are much less costly to manufacture than lasers-they're basically a pulsed laser without the costly laser components such as the laser rod, pump chamber, optics, and delivery device. Broadband light has the ability to target multiple chromophores, including blood and melanin, and although cutoff filters can modify the emitted broadband spectrum to some extent, it cannot match the specificity of monochromatic laser light. Any photons not absorbed by the target chromophore will be absorbed by other chromophores and then dissipated as heat. This "collateral damage" has actually been touted as an advantage of IPL over lasers by some proponents, but in reality the amount of energy delivered to the intended target may be compromised by undesirable effects on adjacent structures.
IPL devices have been aggressively marketed to physicians as a less expensive, "one box" alternative to multiple dedicated lasers. In addition to versatility, IPL devices have the advantage of larger spot sizes than lasers, which is useful for treating large areas quickly. Their lack of specificity limits their use, especially in darker skinned patients. As a rule IPL devices are less effective than a dedicated laser for a given task.
The cogent portion in the information above is bolded in red. Perhaps those suffering fat loss/atrophy have this collateral damage, with the collatateral damage mentioned as almost an aside rather than the real side-effect it has most assuredly become.

If you have doubts this collateral damage exists, please, meet the collateral damage-all of whom are members of the IPL/laser support board:

Member #1: VBeam - January - September of 2007 -5 treatments over entire face- orange peel texture, pitted and linear scars at cheeks, pitted scars at temples and a few at jaw-line, enlarged pores, fat loss over entire face, indentations at temples, forehead, jaw-line. skin is hyper-sensitive to all topicals - flushes red. changes most notable 4-6 weeks after last procedure. - IPL 1999- 3 treatments over entire face- pock mark scar and mole noted on left cheek within weeks of last procedure- indentations at temples with fat loss at temples noted months later.

Member #2: IPL -Fall 2007-Two treatments on face and neck-Complications include pin pricks on cheeks; pitted scars, ice pick scars on cheeks, chin, temples, forehead; lines like etchings or stab wounds that go in all directions on cheeks, nose, near lips, temples, chin; blotchy, hyperpigmented skin all over face. I look diseased.
Enlarged pores on cheeks, nose, forehead, chin, between nose and lips. Looks like orange peel. Wrinkles everywhere, sagging skin around eyes; fat loss all over face and neck. Thinned out skin. Overly sensitive to skin products that had been used safely in the past. Skin burns easily now. Roughened texture to skin on top of everything else. Prone to breakouts. Damage still going.

Member #3: Non-Ablative laser - Late 2007- 1 treatment resulted in 2 ndented lines that became visible within the early weeks following procedure. Volume loss right next to it in my upper right cheek that continued very slowly over the following year.

Member #4: IPL Sept. 2005 (thought it would help my rosacea) Two IPL treatments - twice in the same week as part of a special 3-part program- thank God I didn't do all 3! The first seemed fine, but I could tell during the second one (when the doctor said he was going to really crank it up) that something was wrong. Sure enough that did me in. This did me in and completely melted/hollowed my entire head. The surface skin itself became very thin and fragile with pinprick holes and even made a few weird moles grow.

Member #5: IPL 2006 - I had a series of 5 IPL sessions for my mild rosacea. Had good results, but on the 5th session the doctor decided to increase power which worsened my rosacea (but no textural damage). I waited 6 months, and saw a very good laser practitioner who decided to give me 2 test patches over a period of 6 months...everything was fine. Went ahead with the full treatment, (doctor decided it would be ok to increase the power slightly ) During the treatment I complained that the IPL treatment was actually burning my face, but he assured me everything would be ok and carried on. Well the rest is history, severe inflammation, severe nose swelling, and a few months later as my skin began to recover I noticed my cheeks were covered in pinprick indentations.
Member #6: IPL - I had about seven-eight treatments previously, spread out over 2-3 years(2006-2007), always with reduction of pigmentation on skin and good result- 5/2008- power increased at this visit- performed on face and chest-Since last treatment: scarring on one cheek immediately- indentations a few minutes after procedure (thermal burns?) which enlarged over 5-6 months; 6 weeks after IPL-cheeks deflated, then indentations formed on both cheeks (ice-pick scars), also squiggly lines all over one cheek, indentations on forehead, lines on nose, indentations and lines between nose and lips, lines/indentations extending from side of mouth down sides of chin, small tears all over skin, pinpoint scarring all over skin, orange peel texture to skin, enlarged pores-wrinkles and thin skin over chest-if I have a blemish it leaves a scar. My skin has lost its former elasticity-I look as though I had severe acne as a child. Changing still....
The story does not get better for the collateral damage group, it only compounds.

Please read the stories of those damaged by government approved cosmetic devices at:

http://iplandlaserdamagesupport.prophpbb.com/