Building National Infrastructure for Evaluation of Breast Implants Before 2006 2006 2011 2012 2013 2016 4/1992: investigational devices 1/1992: voluntary moratorium on the sale and implantation 4/1991: Final Rule call for PMAs 1988: Reclassified as Class III 1978: Class II device (panel) 1963: silicone gel-filled BI on market (pre-amendment) 11/2006: FDA approved two silicone gel-filled PMAs with 6 PASs each 2011 initiated development/data collection of PROFILE registry 8/2011: BI Postmarket Advisory Panel 5/2011: updated safety of silicone gel-filled BI 1/2011: posted ALCL on FDA website 10/2012: started working on developing National BI registry 3/2012: approved a silicone gel-filled BI from a new manufacturer 2/2013, 6/2013: approved two silicone gel Bis (higher degree of cohesivity) with 6 PASs each 12/2016: Updated PROFILE protocol and data collection forms 2016: completed NBIR pilot phase I 2017 3/2017: FDA updated BIA-ALCL website with new MDR and literature data 2017: NBIR pilot phase II Breast Implant FDA/Regulatory History National Breast Implant Registry (NBIR) ALCL Post - Market Surveillance Patient Registry and Outcomes for Breast Implants and ALCL Etiology and Epidemiology (PROFILE) Methods Two 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 (Prepared by Asiyah Yu Lin on behalf of DEPI/OSB/FDA) • Collaboration between ASPS, PSF, FDA, and Breast Implant Device Manufacturers • Safety Surveillance Registry and Quality Improvement Initiative • Tracking patient safety, effectiveness, and outcomes for reconstructive and aesthetic procedures • Multi-year registry that collects patient demographic, risk/co-morbidity, procedural, and complication/adverse event data related to breast implants • Vehicle in which Device Tracking Data elements can get to the Manufacturers for their federally mandated Device Tracking purposes, as well as pre and post market studies. • Plans to launch broadly in early 2018 Primary goal: to better understand the role of the breast implants in the etiology of primary ALCL in patients with breast implants, and to identify potential risk factors and criteria detection and management of this disease. Please contact Dr. Nilsa Loyo-Berríos for joining the project! [email protected] (https://www.thepsf.org/research/registrie s/profile)
Welcome message from author
This document is posted to help you gain knowledge. Please leave a comment to let me know what you think about it! Share it to your friends and learn new things together.
Transcript
-
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)
Related Documents
