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1、TextA/ 509Words/ Timeforreading:3.5minutes/TheEuropeanCommissionsaidonThursdayitwouldtoughentheregulationofmedicaldevices asaresultofconcernsraisedbybreastimplantsproducedbythedefunctFrenchcompany PIP,evenasascientificexpertreviewitorderedconcludedtherewascurrently“insufficientevidence” thatwome
2、nusingitsproductsfaced greaterhealthrisksthanothers.JohnDalli,healthandconsumerpolicycommissioner,pledgedtoexaminesurveillanceand operationofthe“notifiedbodies”thatscrutinisemedicaldevicesacrosstheEUinacurrentreview oflegislation,stressing:“Thecapacitytodetectandminimisetheriskoffraudmustbeincre
3、ased.”HiscommentsfollowedanofficialreportreleasedonWednesdayinFrancethatcalledfornational andEU-wideco-operationincludingrandominspectionsandsamplingofmedicaldevices topreventarepeatofthefraudulentuseofsubstandardnon-medical-gradesiliconebyPIPinimplants soldtoupto400,000womenaroundtheworld.Xavie
4、rBertrand,France’sministerofhealth,calledforenhancedactioninFranceandacross Europeinthewakeofthestudy,whichhighlightedthatAfssaps,theFrenchmedicalregulator, didnotinspectPIPfrom2001untilatip-offledofficialstoinspectandclosedownthecompany in2010.Jean-ClaudeMas,itsfounder,isunderpoliceinvestigatio
5、nformanslaughter.Mr.Bertrandhaspledgedtohiremorehealthinspectorsandundertakerandomcheckson medicaldevicecompaniesfollowinggrowingconcernsoveritsregulatorysystemhighlightedby thewidespreaduseofPIP’ssubstandardbreastimplants.AFrenchdecisionattheendoflastyeartoofferallwomenfreeremovalofPIPimplantst
6、riggered similarproposalsintheUK,GermanyandtheCzechRepublicandhashelpedsparkafreshdebateover tougherEUregulationofmedicaldevices,whicharesubjecttofarlessscrutinythanpharmaceuticals.However,areviewreleasedonThursdaybytheEU’sownScientificCommitteeonEmerging andNewlyIdentifiedHealthRisksconcluded:“
7、Breastimplantscanfail,regardlessofmanufacturer, andtheprobabilityoffailureincreaseswithtimesinceimplantation.Inmostcases,breast implantfailureappearstobewithoutidentifiablehealthconsequencesforthepatientwiththeexception ofpo
