The International Breast Implant Registry

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 will 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 will 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," said Dr. Moris Topaz, secretary-general of EQUAM (the European Committee on Quality Assurance and Medical Devices in Plastic Surgery), and a member of the executive committee of IPRAS (the International Confederation for Plastic, Reconstructive and Aesthetic Surgery). "The IBIR and the national registries, those currently active and those which will be set up, need to be compatible in order to increase incorporation of data."

Dr. Topaz added: "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."

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