The Poly Implant Prothese (PIP) Breast Implant Scandal is one of the most significant patient protection failures in the history of clinical research.
As traumatic as it was for the patients involved, it has also been credited in part for triggering significant regulatory changes in the European Union—including the new EU MDR requirements.
Here's a look back at what happened and how the regulatory landscape in Europe has changed as a result.
What Is The PIP Breast Implant Scandal?
In 1965, plastic surgeon Henri Arion introduced breast implants to France. Jean-Claude Mas, a former butcher turned medical sales representative, and Henri Arion worked together in this field; following the death of Arion in a plane crash, Mas went on to launch Poly Implant Prothese (PIP) in 1991. It was the beginning of a company that would produce approximately two million sets of silicone breast implants over the course of a 20 year period and in its path, create a global health scare and shape medical device regulations.
The silicone-based scandal came about when PIP implants made from a cheaper, industrial-grade silicone (that was not approved for medical use) were rupturing at a rate that was double the industry average. When compromised, the silicone gel was known to cause inflammation and possible scarring, and these implants continue to raise questions over the possibility of other harmful long-term affects. The timeline below summarizes the key points of the complex story:
The PIP Breast Implant Scandal Timeline
- 1991: PIP launched by Jean-Claude Mas
- 1992: US Food and Drug Administration (FDA) calls for voluntary moratorium on use of silicone gel implants and implant sales are halted in the US
- 1994: PIP sells hydrogel implants
- 1996: PIP begins selling saline-filled implants in US
- 1997: PIP authorized to produce medical-grade silicone implants
- 2000: FDA refuses to approve PIP’s saline-filled implants and warns about deviations from “good manufacturing practices” found at the PIP plant. Additionally, the company withdraws its hydrogel implants from the market when it cannot show they are safe.
- 2001: PIP starts using unapproved, (“in-house” formula) industrial-grade silicone in their implants
- 2003: The first signs of legal problems and financial losses can be traced by regulatory filings
- 2009: Concerns surfaced in France when surgeons started reporting abnormally high rupture rates; a flood of legal complaints and the company’s bankruptcy resulted. In addition, the UK regulatory authority is warned of a number of medical claims
- 2010: PIP was placed into liquidation after the French medical safety agency recalled its implants.
- 2011: The French government recommended that 30,000 women with PIP implants seek removal of the implants as a precaution
- 2012: Jean-Claude Mas, the founder of Poly Implant Prothese is arrested as France launches an investigation into the scandal
- 2013: Mas sent to prison for four years, fined 75,000 euros, and banned for life from working in medical services or running a company. Mas also faces two additional pending legal cases, one for involuntary manslaughter and another linked to the financial implications of the scandal.
- 2016: Mas’s sentence upheld by appeal court
- May 25, 2017: new European Medical Devices Regulation (MDR) published and in force, with transition period for manufacturers to comply over 3 years
The EU MDR Requirements
The PIP breast implant scandal made it clear that immediate improvements in the oversight of medical devices were needed. As a result, the European Commission embarked on a full regulatory overhaul of the medical device regulations with the goals of providing high levels of safety and restoring public confidence.
The new regulatory framework around the medical device industry, often called the European Medical Devices Regulation (MDR) includes Regulations (EU) 2017/745 and 2017/746 and the following points:
- Extension of the scope of medical device regulation to cosmetic/aesthetic devices
- More stringent requirements for compliance from manufacturers to ensure patient safety
- Creation of a national registry where manufacturers have to register themselves and the devices they place on the EU market in a central database; the goal of the registry is to guarantee traceability through unique device identification
- Ban on aggressive marketing (competitions, BOGO offers, and so called “Mother/Daughter” deals)
- Improved training and qualification standards were set for cosmetic surgery providers
- Greater transparency is required along the entire supply chain of devices
- Establishment of an EU portal where manufacturers would be required to report serious events and corrective actions to reduce the risk of recurrence
- Increased rights and responsibilities for Notified Bodies (certification organizations) and their monitoring of all medical devices, including breast implants
The MDR requirements go into effect May 26, 2020. Another set of similar requirements for in vitro diagnostic devices (IVDR) take effect two years later in 2022.
What This Means For Manufacturers
These requirements will not allow grandfathering of previously approved products, so device manufacturers will need to re-evaluate their entire product portfolio to identify the steps needed to ensure compliance. This impacts every aspect of the organization, from research and development to manufacturing and marketing.
Medical device manufacturers will likely need additional clinical data to certify and re-certify devices, which could be gathered or generated from various sources and methods. They will also need to perform additional post-market surveillance to provide safety and effectiveness oversight for the lifecycle of a device.
There are many understandable concerns about how this will impact device companies, and there are still many unknowns.
However, with the deadline looming, manufacturers should be taking steps now to prepare.
One of the most important first steps they can take is to ensure they have a compliance-minded clinical research organization (CRO) that specializes global medical device trials.
In this resource, we’ll discuss the most important elements you need to know and how you can start preparing. Explore our MDR requirements resource to get started.
Note: This post was previously published Nov. 7, 2017 and has been updated with new information.