IBIR Background and History
The concept of the International Breast Implant Registry (IBIR) was formulated in an endeavor to provide patients, physicians, regulatory bodies and manufacturers with essential and updated information that would improve knowledge and ensure safety in the use of breast implants.
The application of any new device in medicine can generate short- and long- term unexpected adverse effects. The registry of breast implants should provide the basic data needed to evaluate and compare the quality of breast implants, to enable early detection of serial defects, to assess short- and long-term reactions and complications. The registry can shorten the time lapse before any health hazard is perceived.
The mutual collaboration on the international registry of breast implants of all kinds is also essential in order to gather full and accurate data related to the full scope of implants (related to various manufacturers), used around the world, in a relatively short time. Since silicone filled breast implants are currently available mainly in Europe and the saline filled implants are mainly used in the US, the combined registry, having basically the same database, can provide us with the unique information we lack regarding short- and long-term malfunctions and complications of these two most widely used implants. The registry can provide data concerning the need for secondary surgery, longevity, rupture, capsular contractures and the comparison between the various types of breast implants.
It is anticipated that the European Parliament and the FDA would impose, in the future, a mandatory registry for breast implants, thus securing larger numbers of plastic surgeons in the project.
IPRAS, ASPS and EQUAM should collaborate in order to incorporate as many aesthetic and reconstructive plastic surgeons as possible in this project. A campaign should be started in order to provide surgeons the incentive to join the registry. The IBIR and the national registries, those currently active and those which will be set up, need to be compatible in order to increase incorporated data.
The breast implant registry should be regarded in the general context of breast implant safety. As concluded at The EQUAM‘s 2000 Consensus Declaration, patients should be provided with complete and updated information prior to their signing a standardized informed consent.
When was it developed?
IBIR was formally
The interest in development of registries arose from published issues and concerns from consumers and federal governments regarding either real or perceived health risks of silicone, specifically breast implants, in the human body, as well as local complications and frequency of re-operations. Interest in collaborating on an international registry was the result of many countries looking for and at the same data, and that there was an opportunity to compare findings as the majority of implants used throughout the world come from the same manufacturers.
IBIR is currently in a pilot phase with the goal of understanding data collection issues and concerns in various countries. The pilot is utilizing an electronic format. This format includes collection of data on a paper worksheet during the physical assessment process, or as a chart abstraction worksheet, following which the data is entered into a web-based program. This allows for real-time aggregation of international data, while maintaining individual country confidentiality. Once the final program is built, it is proposed that IBIR would report aggregate international data, identify and prioritize an international research agenda regarding breast implants while it would provide country specific reports back to participants in that country.
What is the IBIR's objective?
IBIR was formed to facilitate the collection and analysis of data generated by patients who have undergone augmentation mammaplasty or breast reconstruction with all types of breast implants.
The primary objective of this organization is the collection of relevant data regarding the utilization, design, surgical implantation, complications, long term outcomes and patient satisfaction. Analysis of this data will allow the application of the knowledge gained to the improvement of breast augmentation and reconstructive procedures.
How is it currently used in practice? - As IBIR is in a pilot phase, the data currently lacks enough scientific rigor to be of clinical benefit at this time.