The quest for a breast implant

Medical devices can suffer from manufacturing defects, but in recent years, barcodes have made it easier to track errors and defects. With GS1 standards and technology, it is now possible to ensure traceability for everything from medicine to implants. The latter was at the center of an international scandal in 2010. It could have been nipped in the bud if barcodes had been as widespread as they are today.

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1. The incident

In 2010, leading doctors discovered that the French company Poly Implant Prothèse had been selling silicone breast implants for medical use, even though the silicone was intended for industrial purposes. In other words, the quality was not at all as promised. Poly Implant Prothèse had engaged in this illegal practice for nine years, but the alarm was only raised when more and more implants began to leak. By that time, up to half a million women worldwide had received the company's breast implants.

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2. Tracking

When the scandal broke, there was no common registry for implant registration. Or for much other medical equipment, for that matter. Therefore, it took a long time to identify the common denominator for the debilitating and, in some cases, fatal consequences experienced by the women with the implants. When investigations pointed toward the implants, a new problem arose: Who had actually received them? Scores of students were sent into clinic basements to see if they could find answers as to who had implants from Poly Implant Prothèse.

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3. New control

Poly Implant Prothèse was not the reason for the creation of a pan-European concept for traceability – but the scandal was a catalyst. It was clear that traceability was lacking, and therefore common legislative frameworks had to be created. The solution became 'Unique Device Identification' (UDI). Since May 2017, the EU has been working toward a system where medical devices (including implants) must be reported and stored in a database. Today, medical devices are divided into different classes from 'high risk' to 'low risk'. Breast implants are 'high risk'.

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4. Database

Most technical barriers to a common European database have now been cleared. Since 2021, it has been possible to report data to the European Database on Medical Devices (EUDAMED). Today, all implants are born with either a batch/lot number or a serial number as a Unique Device Identification Production Identifier (UDIPI). This is about ensuring traceability throughout the process should a problem arise. Now, it is possible to zoom in directly on the individual product. There is no longer any need to send people down into a basement in the hope that they will find the owner of a damaged implant.

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5. Registration and standards

EUDAMED – the European Database on Medical Devices – is the place where manufacturers can already register their products and ensure that the master data for their products is correct. The more information, the better the control. There are clear standards for what must be included in the database. Therefore, EUDAMED is also the tool that will help if an incident involving medical devices occurs. The database is not yet fully completed, but it is on its way.

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