From the PIP Scandal to MDR: A New Era in Medical Device Regulation

1. The Genesis of the Scandal: PIP’s Fatal Decision

In 2001, Poly Implant Prothèse (PIP), a medical device manufacturer based in the small French town of La Seyne-sur-Mer, made a decision that would eventually threaten the lives of women worldwide, becoming the catalyst for a major scandal. Jean-Claude Mas, the founder of PIP, began using industrial-grade silicone gel (a material typically used for coating electrical wires) instead of medical-grade silicone in order to reduce costs. This industrial silicone cost approximately one-tenth of medical-grade silicone, achieving a cost reduction of about 90%. This decision represented a fatal error—prioritizing short-term profits at the expense of patient safety.

PIP was subject to annual audits by TÜV Rheinland, a German notified body. However, since inspections were announced 10 days in advance, factory staff were able to conceal evidence of the industrial silicone before inspections took place. Furthermore, regulations at the time did not require re-testing of the chemical composition of products after certification was obtained, and unannounced inspections were not conducted. As a result, this fraudulent practice went undetected for many years.

2. Discovery of the Problem: Abnormal Rupture Rates and Sales Prohibition

Beginning in the mid-2000s, French surgeons and numerous patients began noticing abnormally high rupture rates in PIP breast implants. While the industry standard rupture rate for breast implants was approximately 1%, PIP products showed rupture rates of 5-10%, with some studies reporting a 500% higher risk compared to other approved products. Cases of implant ruptures and leakage of harmful substances into patients’ bodies occurred in rapid succession. Even more seriously, a phenomenon called “gel bleeding” was observed, where gel would seep out even when implants had not ruptured.

The UK Medicines and Healthcare products Regulatory Agency (MHRA) had been receiving reports of problems with PIP products as early as 2002, receiving 269 adverse event reports between 2001 and 2009. These concerns were communicated to the manufacturer starting in 2003, but adequate action was not taken.

On March 29, 2010, the French Agency for the Safety of Health Products (AFSSAPS, now renamed ANSM) prohibited the sale and use of PIP breast implants. An unannounced inspection by AFSSAPS revealed that PIP had been using unapproved industrial silicone gel instead of the medical-grade NUSIL gel specified in their application documents. On the same day, PIP entered liquidation proceedings with debts of 9 million euros.

3. Global Impact: Fear Spreading Worldwide

This decision sent shockwaves around the world. An estimated 300,000 to 400,000 implants had already been used in more than 65 countries worldwide. PIP had manufactured approximately 2 million sets of breast implants over a 20-year period and was the world’s third-largest breast implant manufacturer. News spread rapidly, plunging women around the world into fear. Many women were tormented by anxiety about whether the implants in their bodies were safe and whether they would suffer health damage.

Among the victims were patients who had received PIP implants during reconstructive surgery following mastectomy as part of breast cancer treatment, making this situation particularly serious for women who needed implants for medical reasons.

Victims experienced various physical problems including siliconomas (silicone granulomas), lymph node swelling, night sweats, unexplained sepsis, inflammation, and joint pain. Tragically, some victims developed breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a newly recognized cancer associated with textured-surface silicone implants, with fatalities reported. The first recorded deaths from BIA-ALCL were among women with ruptured PIP implants.

On December 23, 2011, the French government recommended that approximately 30,000 women in France have their PIP implants removed as a precautionary measure. France’s public health insurance decided to cover the costs of implant removal and replacement (estimated at 60 million euros) when used for medical reasons, but costs for new implants when used for cosmetic purposes would be borne by patients themselves.

In the UK, an estimated 30,000 to 40,000 women were affected. In June 2012, a report by an expert panel led by Sir Bruce Keogh concluded that “PIP implants have not shown any evidence of significant risk to human health.” However, this conclusion faced criticism from medical professionals. The report also acknowledged that PIP products had double the rupture rate of other products.

4. Regulatory Response: Development of the MDR

European regulatory authorities took this situation very seriously. Deficiencies in existing medical device regulations became apparent, and the need for more stringent regulation was strongly voiced. The PIP scandal exposed the following significant flaws in the existing Medical Device Directives (MDD 93/42/EEC and AIMDD 90/385/EEC):

• Inadequate oversight by notified bodies
• Weak post-market surveillance systems
• Lack of product traceability
• Limitations of pre-announced inspections
• Absence of requirements for re-testing product chemical composition after certification

In 2012, the European Union (EU) developed an action plan (the so-called PIP Joint Action Plan) to strengthen market surveillance and develop new regulations for medical devices. The European Commission embarked on developing a new regulatory framework, and after years of discussion and preparation, the European Union (EU) formally adopted the Medical Device Regulation (MDR, Regulation (EU) 2017/745) on April 5, 2017. The MDR entered into force on May 25, 2017, but to provide manufacturers and regulatory authorities with sufficient transition time for adaptation, full implementation was initially scheduled for May 26, 2020.

5. Characteristics of the MDR: Innovative Safety Measures

The MDR incorporated many innovative elements, learning from the lessons of the PIP scandal.

5.1 Expansion of Product Scope

The MDR expanded its regulatory scope by including products without a medical purpose (such as colored contact lenses and dermal fillers). This brought products with characteristics and risks similar to medical devices under appropriate safety standards.

5.2 Rigorous Post-Market Surveillance System

The MDR strengthened continuous monitoring throughout the lifecycle of medical devices. Manufacturers are obligated to implement post-market surveillance (PMS) plans, periodic safety update reports (PSURs), and post-market clinical follow-up (PMCF). This ensures that safety and performance continue to be monitored even after products enter the market.

5.3 Revision of Medical Device Classification System

Annex VIII of the MDR expanded from the previous 13 classification rules to 22 rules. Particularly important new classification rules include:

• Rule 11: Clear classification of Software as a Medical Device (SaMD)
• Rule 19: Classification of devices containing nanomaterials
• Rule 21: Classification of substance-based medical devices

Reusable surgical instruments were also included in their own category (Class Ir), and from May 26, 2024, aspects related to reprocessing and (re-)sterilization became subject to notified body review.

5.4 Enhanced Clinical Evaluation and Risk Management

The MDR significantly strengthened clinical evaluation requirements, demanding more rigorous clinical evidence. For high-risk devices (Class III and implantable devices), creation of a Summary of Safety and Clinical Performance (SSCP) is mandatory, which is made publicly available through the EUDAMED database.

5.5 Introduction of the UDI (Unique Device Identification) System

The UDI system facilitates product tracking and improves market surveillance by assigning unique identifiers to all medical devices. UDI includes device identifiers (UDI-DI) and production identifiers (UDI-PI). This enables rapid identification of affected products and notification of patients in cases like the PIP scandal.

5.6 Introduction of the Person Responsible for Regulatory Compliance (PRRC)

Article 15 of the MDR requires manufacturers and authorized representatives to have a Person Responsible for Regulatory Compliance (PRRC) within their organization. PRRCs must meet certain qualification requirements regarding education and experience and bear several duties and responsibilities, including ensuring fulfillment of post-market surveillance obligations.

5.7 Strengthened Oversight of Notified Bodies

The MDR tightened designation requirements for notified bodies and strengthened qualification requirements for audit staff. Processes for regular supervision and re-assessment of notified bodies themselves were also introduced.

5.8 Introduction of the EUDAMED Database

The EUropean DAtabase on MEdical Devices (EUDAMED) is a database for collecting and publishing information on medical devices and in vitro diagnostic medical devices. Data on economic operators, device registration, and certificates are made publicly available, linking manufacturers’ certification with Single Registration Numbers (SRN) and Basic UDI. EUDAMED increases transparency and enables patients and healthcare professionals to easily access information about medical devices.

6. Dawn of a New Era: Full Implementation of the MDR

Due to the COVID-19 pandemic, the full implementation date of the MDR was postponed by one year to May 26, 2021. This day marked the dawn of a new era for the European medical device industry. The MDR, born from the tragedy of the PIP scandal, became a beacon of hope promising patient safety and improved quality of medical devices.

Initially, certificates issued under MDD/AIMDD were to remain valid until May 26, 2024, but due to insufficient notified body capacity and manufacturer unpreparedness, Regulation (EU) 2023/607 was adopted in March 2023, extending the transition period in stages under certain conditions:

• Class III and implantable devices: Until December 31, 2027
• Other Class II devices: Until December 31, 2028

However, to benefit from this extension, manufacturers must meet several requirements, including updating their quality management systems to MDR requirements by May 2024, ensuring continued surveillance by notified bodies, and not making significant design changes or changes to intended use.

7. Legal Liability and Compensation

The legal aspects of the PIP scandal also left important lessons. PIP itself, which went bankrupt in 2010, was unable to pay damages to victims. PIP’s insurer, Allianz, also claimed that the insurance contract was void because the company had deliberately engaged in fraudulent activities.

Therefore, many victims filed lawsuits against the notified body, TÜV Rheinland:

• December 10, 2013: Jean-Claude Mas was sentenced to four years in prison and fined 75,000 euros for fraud, and was permanently banned from working in the healthcare field and managing any company. Mas died in 2019 at the age of 79.
• 2013: The court ordered TÜV Rheinland to pay 4,000 euros to each victim.
• 2017: The Toulon court ordered TÜV Rheinland to provisionally pay 60 million euros to 20,000 victims (TUV3 case), or 3,000 euros per victim.
• May 2021: A French appeals court issued a landmark ruling that TÜV Rheinland was negligent and should be partially liable for damages. The court determined that TÜV Rheinland had failed to fulfill its duties of inspection, due diligence, and vigilance in annual inspections. This ruling concerned approximately 2,700 victims (including 540 British citizens), with compensation of tens of thousands of euros per victim being sought.
• May 2025: France’s highest court (Court of Cassation) confirmed TÜV Rheinland’s responsibility in the PIP implant case.

This series of legal proceedings clarified the importance of notified body responsibility and the need for appropriate oversight systems. The MDR reflects these lessons, significantly strengthening notified body responsibilities and oversight structures.

8. Ongoing Challenges and Lessons Learned

However, this story is not yet over. The PIP scandal and the establishment of the MDR have left profound lessons for the medical device industry.

8.1 Prioritization of Patient Safety

Patient safety must always take priority over cost reduction and profits. Because medical devices directly affect people’s health and lives, the highest standards of quality control and safety are required.

8.2 Importance of Rigorous Quality Control

Rigorous quality control throughout the manufacturing process, effective oversight by notified bodies, and continuous post-market monitoring are essential. The limitations of pre-announced inspections were also recognized, emphasizing the importance of unannounced inspections and re-testing of products after certification.

8.3 Importance of the Role of Regulatory Authorities

Regulatory authorities play a crucial role in ensuring the safety of medical devices and protecting patients. Appropriate legal frameworks, adequate resources, and strict enforcement are necessary.

8.4 Transparency and Traceability

Tools that improve transparency and traceability, such as the UDI system and EUDAMED database, enable rapid response when problems occur.

8.5 Unresolved Issues

Meanwhile, many victims have still not received compensation, and some women do not even know whether they have PIP implants. It is particularly difficult for women who underwent surgery abroad or whose clinics have gone out of business to verify the type of implants they have. Additionally, recommendations and responses regarding compensation vary across different parts of the world, creating disparities in victims’ suffering.

9. Looking to the Future: Pursuit of Safety and Trust

The global medical device industry, including Japan, has taken these lessons to heart and is striving to develop safer and more reliable products. While Japan has its own regulatory framework based on the Pharmaceuticals and Medical Devices Act (PMD Act), the importance of international regulatory harmonization is also recognized.

The MDR, born from the dark past of the PIP scandal, is illuminating the path to a brighter medical future. This regulation goes beyond being merely a legal framework; it continues to evolve as a bulwark protecting patient safety and trust. The MDR promotes a paradigm shift from the pre-approval stage to a lifecycle approach spanning the entire period after market introduction, similar to the lifecycle approach advocated by the U.S. Food and Drug Administration (FDA).

Regulatory authorities outside the EU are also learning from the PIP scandal. On June 6, 2025, the UK Parliament’s Women and Equalities Committee announced a formal inquiry into breast implant and cosmetic procedure safety. This inquiry will examine informed consent, regulation, cosmetic tourism, and gaps in medical device safety research, demonstrating that survivor-led advocacy is bearing fruit.

The medical device industry, regulatory authorities, healthcare professionals, and patients must work together in ongoing efforts to ensure that tragedies like the PIP scandal never happen again. Transparency, accountability, and above all, an unwavering commitment to patient safety should form the foundation shaping the future of medical devices.