building national infrastructure for evaluation of breast...
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BuildingNationalInfrastructureforEvaluationofBreastImplants
Before2006
2006
2011
2012
2013
2016
4/1992:investigationaldevices1/1992:voluntarymoratoriumonthesaleandimplantation4/1991:FinalRulecallforPMAs1988:ReclassifiedasClassIII1978:ClassIIdevice(panel)1963: siliconegel-filledBIonmarket(pre-amendment)
11/2006:FDAapprovedtwosiliconegel-filledPMAswith6PASseach
2011initiateddevelopment/datacollectionofPROFILEregistry8/2011:BIPostmarket AdvisoryPanel5/2011:updatedsafetyofsiliconegel-filledBI1/2011:postedALCLonFDAwebsite
10/2012:startedworkingondevelopingNationalBIregistry3/2012:approvedasiliconegel-filled BIfromanewmanufacturer
2/2013,6/2013:approvedtwosiliconegelBis (higherdegreeofcohesivity)with6PASseach
12/2016: UpdatedPROFILEprotocolanddatacollectionforms2016:completedNBIRpilotphaseI
2017 3/2017:FDAupdatedBIA-ALCLwebsitewithnewMDRandliteraturedata2017:NBIRpilotphaseII
BreastImplantFDA/RegulatoryHistory NationalBreastImplantRegistry(NBIR) ALCLPost-MarketSurveillance
PatientRegistryandOutcomesforBreastImplantsandALCL EtiologyandEpidemiology(PROFILE)
MethodsTwo data sources (literature and medical device adverse events reports (MDRs)) are extracted and cleaned systematically. Analyses are conducted by each data source, regarding:
◦ implant fill (e.g. silicone gel, saline)◦ implant surface (e.g. textured, smooth)◦ time to diagnosis/reporting◦ ALCL biomarkers◦ Other clinical data
Results
◦ Fill types: 35% Saline vs. 52% Silicone in MDRs, and 44% Saline vs. 56% Silicone in literature.
◦ Surface types: textured surface was much more frequent than smooth surface (90% vs 1% in literature, and 57% vs 8% in MDR).
Through February 1, 2017, the FDA received a total of 359 medical device reports (MDRs) of breast implant associated anaplastic large cell lymphoma (BIA-ALCL), including nine deaths. There are 231 reports with data on surface information at the time of reporting. Of these, 203 were on textured implants and 28 on smooth implants. There are 312 reports with data on implant fill type. Of these, 186 reported the use of silicone gel-filled implants, and 126 reported the use of saline-filled implants .
ASPS
(PreparedbyAsiyahYuLinonbehalfofDEPI/OSB/FDA)
•Collaboration betweenASPS,PSF,FDA,andBreastImplantDeviceManufacturers•SafetySurveillanceRegistryandQualityImprovementInitiative•Trackingpatientsafety,effectiveness,andoutcomesforreconstructiveandaestheticprocedures•Multi-yearregistrythatcollectspatientdemographic,risk/co-morbidity,procedural,andcomplication/adverseeventdatarelatedtobreastimplants•VehicleinwhichDeviceTrackingDataelementscangettotheManufacturersfortheirfederallymandatedDeviceTrackingpurposes,aswellaspreandpostmarketstudies.•Planstolaunchbroadlyinearly2018
Primarygoal:tobetterunderstandtheroleofthebreastimplantsintheetiologyofprimaryALCLinpatientswithbreastimplants,andtoidentifypotentialriskfactorsandcriteriadetectionandmanagementofthisdisease.
Please contact Dr. Nilsa Loyo-Berríos for joining the [email protected](https://www.thepsf.org/research/registrie
s/profile)