TextA/509Words/Timeforreading:3.5minutes/TheEuropeanCommissionsaidonThursdayitwouldtoughentheregulationofmedicaldevicesasaresultofconcernsraisedbybreastimplantsproducedbythedefunctFrenchcompanyPIP,evenasascientificexpertreviewitorderedconcludedtherewascurrently“insufficientevidence”thatwomenusingitsproductsfacedgreaterhealthrisksthanothers.JohnDalli,healthandconsumerpolicycommissioner,pledgedtoexaminesurveillanceandoperationofthe“notifiedbodies”thatscrutinisemedicaldevicesacrosstheEUinacurrentreviewoflegislation,stressing:“Thecapacitytodetectandminimisetheriskoffraudmustbeincreased.”HiscommentsfollowedanofficialreportreleasedonWednesdayinFrancethatcalledfornationalandEU-wideco-operationincludingrandominspectionsandsamplingofmedicaldevicestopreventarepeatofthefraudulentuseofsubstandardnon-medical-gradesiliconebyPIPinimplantssoldtoupto400,000womenaroundtheworld.XavierBertrand,France’sministerofhealth,calledforenhancedactioninFranceandacrossEuropeinthewakeofthestudy,whichhighlightedthatAfssaps,theFrenchmedicalregulator,didnotinspectPIPfrom2001untilatip-offledofficialstoinspectandclosedownthecompanyin2010.Jean-ClaudeMas,itsfounder,isunderpoliceinvestigationformanslaughter.Mr.BertrandhaspledgedtohiremorehealthinspectorsandundertakerandomchecksonmedicaldevicecompaniesfollowinggrowingconcernsoveritsregulatorysystemhighlightedbythewidespreaduseofPIP’ssubstandardbreastimplants.AFrenchdecisionattheendoflastyeartoofferallwomenfreeremovalofPIPimplantstriggeredsimilarproposalsintheUK,GermanyandtheCzechRepublicandhashelpedsparkafreshdebateovertougherEUregulationofmedicaldevices,whicharesubjecttofarlessscrutinythanpharmaceuticals.However,areviewreleasedonThursdaybytheEU’sownScientificCommitteeonEmergingandNewlyIdentifiedHealthRisksconcluded:“Breastimplantscanfail,regardlessofmanufacturer,andtheprobabilityoffailureincreaseswithtimesinceimplantation.Inmostcases,breastimplantfailureappearstobewithoutidentifiablehealthconsequencesforthepatientwiththeexceptionofpossiblelocalcomplications.”Itstressedthatlimiteddatameantthatwhiletherewasnolinkbetweenbreastimplantsandcancer,therewasaneedforfurtherworktounderstandthespecificrisksfromthePIPproducts.Mr.BertrandhasendorsedcallsforaparliamentaryinquiryinFranceaswellasareportfromthecountry’ssocialaffairsinspectorate,mirroringsimilarmovesthatledtotoughnewrequirementsforthepharmaceuticalindustryintroducedlastyearinthewakeofconcernsaboutServier’sdrugMediator.Medicaldevicemanufacturershavecalledforreformstoensurethatthenational“notifiedbodies”whichauditthequalityoftheirproductsacrossEuropeareofaconsistentlyhighstandard,whilecautioningthattoughnewregulatoryrequirementscouldharmtheEU’sco...