IBIR
Background and History
Abstract
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
organized in
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.