It was during my legal studies that the PIP-case came to my attention. Tragic, but fascinating to me, was the fact that things could have gone so wrong, and that the legal framework could be so outdated. This was the beginning of my critical view of the law, as I still see the law lagging behind societal and technological developments. Through NAALA I can apply my in-depth legal knowledge and critical view of the law to new situations and developments. After all, the law should not work against anyone having good intentions; the law should support future- and solution-orientated ideas. At the same time, fraudulent practices such as in the PIP-case must be thwarted by the law. At least the latter was the thought of the legislators as well. This blog describes the PIP-case and its consequence: the Medical Device Regulation (MDR).

Over many years, the Poly Implant Prothèse (PIP) Company fraudulently made use of industrial silicone instead of medical grade silicone in many of the breast implants they manufactured. During the procedure, in which an independent notified body determined whether the implants were safe to market, the company actually used the silicone gel that was approved for medical use. However, at some point the company replaced this medical silicone gel with (comparatively cheaper) industrial silicones. Under the applicable legal framework – the Medical Device Directive (MDD) – audits were carried out by notified bodies on a regular basis to check whether the products, which they had approved for marketing, still met the applicable standard for safety and efficacy.

However, at that time the audits were always pre-announced. The story goes that as soon as the company knew the notified body would be coming for an audit, the barrels of industrial silicones were hidden and the barrels of medical silicones were brought into the manufacturing facility specifically for the audit. In this way, they could make it appear that all breast implants were manufactured in the approved manner. Once the notified body had left the facility, the barrels of medical silicone would make way for the industrial silicone again.

Were there literal barrels rolling in and out of the manufacturing facility? Probably not. Was the notified body fooled? Yes it was. Just like the (estimated) 400.000 women worldwide who received PIP breast implants.

The fraudulent activities remained undiscovered until 2010, when investigations were finally triggered by an unusually high number of ruptured breast implants in a short period of time. Even though ruptured PIP implants have no proven long-term health effects, it can cause unpleasant symptoms such as redness, pain and tenderness, lumpiness or swelling in and around the breast. Moreover, such fraudulent production is obviously punishable by law.

Triggered by this scandal, questions arose about the effectiveness of the regulatory framework around medical devices in Europe. The PIP Action Plan was issued in 2012. As part of the plan, notified bodies were required to perform unannounced audits on a regular basis at manufacturers’ and critical suppliers’ facilities to prevent practices like the “rolling barrels” from repeating.

At the same time, European legislation on medical devices was already being revised. There had been formal consultations in 2008 and 2010. However, when the new legislation was about to being proposed in 2012, the European Commission had no choice but to adjust the proposals in response to scandals like this one. There was a need and a necessity for stricter controls for high-risk medical devices before they are put on the market. This, as well as a more centralized enforcement of the law, is reflected in both the new MDR and the new In-Vitro Diagnostic Medical Device Regulation (IVDR).

Curious about what the MDR and IVDR change for you? Feel free to get in touch and keep following us, as we will be taking a closer look at the changes brought about by the MDR and IVDR in subsequent blogs.