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implants - international magazine of oral implantology

According to business report provider GBI Research, the dental implants market issettoalmostdouble invalueoverthenext sixyears.Owingtotechnological advancements and the aging population world- wide,thecompanyexpectsarapidincreaseinthe useofdentalimplantsinthenearfuture.Ananalysisof themarketfortitaniumandzirconiumdentalimplants revealedthattheglobaldentalimplantsmarketisex- pectedtogrowatacompoundrateof10percentfrom $3.4 billion in 2011 to $6.6 billion in 2018, GBI Re- search’shealthcareexpertssaid.Theyfoundthatthe market is mainly driven by growing concerns about oralhygiene,increasinglifeexpectancyandtheavail- abilityofadvancedsolutionsfordentalimplantsbased on digital dentistry, which increases procedure effi- ciency and reduces the incidence of adverse out- comes. Moreover, the investigators observed an in- creasingpreferencefordentalimplantsasatreatment option over conventional devices such as crowns, bridgesordentures. I 49implants1_2013 Dental implants market Will double by 2018 TheAmerican Food and DrugAdministration (FDA) has proposed a reclassification of blade-form en- dosseous dental implants commonly used in den- tal restoration from Class III to Class II devices,re- ducing the regulatory requirements for marketing these implants. The FDA recognises three classes of medical de- vicesbasedonthelevelofcontrolnecessarytoas- sure safety and effectiveness. While Class II de- vices,i.e.medium-riskdevices,aresubjecttogen- eral and special controls, Class III devices are highly regulated. Usually, Class III devices support or sustain human life, or are of substantial impor- tance in preventing impairment of human health, but may present a potential, unreasonable risk of illness or injury. In many cases, premarket approval is required to ensure the safety and effectiveness of these de- vices. The FDA said that it has proposed the reclassification of blade-form en- dosseous dental implants based on new informationregardingtheirhealthbenefits andriskincidencespublishedsincetheor- ganisation‘s prior recom- mendation. “FDA has been reviewing these de- vicesformanyyearsandtheirrisksarewellknown. A review of the applicable clinical literature indi- cates that the device has a high success rate and that few relevant adverse events have been re- ported in the case of these devices or related devices, suggesting that the de- vice has a high long-term safety profile,” the organisation stated. In addition to complying with general con- trols,theimplantswouldbesubjectto special controls, including special labelling requirements, mandatory performancestandardsandpostmar- ket surveillance. However, premarket approval would no longer be mandatory to effectively mitigate possible health risks,includ- ing infection and adverse tissue reac- tions. Electronic or written submissions on the proposal can be submitted by April 15, the organisation stated. FDA considers Reclassification of dental implants TheEUhealth-caresectorisfacinghardtimes.With an ageing work-force and insufficient new recruits toreplacethosewhoareretiring,thefuturedoesnot look promising.Owing to demanding working con- ditions and relatively low pay in some health occu- pations, recruits are not attracted to the sector. A while ago, the EU member states invited the EC to proposeanactionplantoassistthemintacklingthe key challenges facing the health work-force in the mediumtolongerterm.Thiscommissionstaffwork- ing document describes the current status of the sector,amongothermatters. Thehealth-caresectorcomprisesworkerswhopri- marilydeliverhealth-careservices,includinghealth professionals (doctors, nurses, midwives, pharma- cists and dentists),allied health professionals,pub- lic-health professionals, health management, and administrative and support staff.Some people also work for the health-care sector indirectly, such as those employed in the health-care industries and support services,pharmaceuticals,medical device industries, health insurance, health research, e- health, occupational health, spa, etc. Most health- care workers are female. More than 13.1 million womenwereemployedinthesectorin2010,mak- ingupmorethanthreequartersofthehealthwork- forceintheentireEU.Healthcareisoneofthelargest sectors in the EU, with around 17.1 million jobs in 2010,whichaccountsforeightpercentofalljobsin theEU-27.Thenumberofjobsinthesectorincreased by21percentbetween2000and2010,creatingfour millionnewjobs.AccordingtotheECdocument,the health-care sector even continued to grow during theeconomiccrisis,withthepositivetrendreflected inallagegroups.Forecastspredictthatitwillremain a growing sector,even though employment growth willbemoremodestcomparedwith2000to2010. EU health-care sector faces Serious recruitment problems [PICTURE:©VIOLETKAIPA] [PICTURE: ©VIOLETKAIPA] [PICTURE: ©MITYA73]