P SF reg i ST rie S ProFile regiSTry In 2011, the pSF, aSpS and the FDa began collaborating on a five-year research project to conduct research and develop a comprehensive breast implant-alCl registry called the patient registry and outcomes for Breast INVESTIGATING ALCL & BREAST IMPLANTS Implants and anaplastic large Cell lymphoma etiology and epidemiology (proFIle). this registry was started in response to reports of a possible link between women with breast implants and anaplastic large cell lymphoma (alCl). It serves as an effort to learn more about whether an association truly exists. the project database was developed in 2012 and the study team is now actively involved in data collection. the pSF serves as the coordinating center for the project and is responsible for all aspects of study coordination and project management. the proFIle protocol received IrB approval in august 2012. potential and confirmed cases of alCl can be reported to the pSF through alCl@plasticsurgery.org naTional breaST imPlanT regiSTry In June 2012, an amendment was made to the existing Cooperative research and Development agreement (CraDa) between the aSpS, the pSF and the FDa to incorporate the exploration and development of a national Breast Implant registry into the existing infrastructure set up for the proFIle study. In october 2012, aSpS, the pSF and the FDa convened a stakeholder meeting with the three device manufacturers with breast implants approved in the united States (allergan, Mentor, and Sientra). the meeting was an opportunity for each stakeholder to discuss their role in the future registry and their expectations. the primary action items from the meeting were to develop two working groups, Scientific Questions and Business operations, that further define the national Breast Implant registry. Since the october 2012 meeting, the Scientific Questions working group has focused on identifying appropriate questions and data points to be addressed by the national Breast Implant registry. a request for proposal was issued, for the purpose of conducting a systematic review of the breast implant literature to help inform which questions are appropriate and relevant for the registry. Pa g e 1 1