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1、TextA/ 509Words/ Timeforreading:3.5minutes/TheEuropeanCommissionsaidonThursdayitwouldtoughentheregulationofmedicaldevices asaresultofconcernsraisedbybreastimplantsproducedbythedefunctFrenchcompany PIP,evenasascientificexpertreviewitorderedconcludedtherewascurrently“insuffici
2、entevidence” thatwomenusingitsproductsfaced greaterhealthrisksthanothers.JohnDalli,healthandconsumerpolicycommissioner,pledgedtoexaminesurveillanceand operationofthe“notifiedbodies”thatscrutinisemedicaldevicesacrosstheEUinacurrentreview oflegislation,stressing:“Thecapacityto
3、detectandminimisetheriskoffraudmustbeincreased.”HiscommentsfollowedanofficialreportreleasedonWednesdayinFrancethatcalledfornational andEU-wideco-operationincludingrandominspectionsandsamplingofmedicaldevices topreventarepeatofthefraudulentuseofsubstandardnon-medical-gradesil
4、iconebyPIPinimplants soldtoupto400,000womenaroundtheworld.XavierBertrand,France’sministerofhealth,calledforenhancedactioninFranceandacross Europeinthewakeofthestudy,whichhighlightedthatAfssaps,theFrenchmedicalregulator, didnotinspectPIPfrom2001untilatip-offledofficialstoinsp
5、ectandclosedownthecompany in2010.Jean-ClaudeMas,itsfounder,isunderpoliceinvestigationformanslaughter.Mr.Bertrandhaspledgedtohiremorehealthinspectorsandundertakerandomcheckson medicaldevicecompaniesfollowinggrowingconcernsoveritsregulatorysystemhighlightedby thewidespreaduseo
6、fPIP’ssubstandardbreastimplants.AFrenchdecisionattheendoflastyeartoofferallwomenfreeremovalofPIPimplantstriggered similarproposalsintheUK,GermanyandtheCzechRepublicandhashelpedsparkafreshdebateover tougherEUregulationofmedicaldevices,whicharesubjecttofarlessscrutinythanpharm
7、aceuticals.However,areviewreleasedonThursdaybytheEU’sownScientificCommitteeonEmerging andNewlyIdentifiedHealthRisksconcluded:“Breastimplantscanfail,regardlessofmanufacturer, andtheprobabilityoffailureincreaseswithtimesinceimplantation.Inmostcases,breast implantfailureappears
8、tobewithoutidentifiablehealthconsequencesforthepatientwiththeexception ofpo
