In the healthcare industry, stories of patient harm can sometimes be the impetus for positive change. This was the case with the PIP breast implant scandal, where cost-cutting decisions that resulted in injuries eventually led to major regulatory updates. 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 effects. The timeline below summarizes the key points of the complex story:
- 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
As a result of the scandal, 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
While the PIP scandal very harshly demonstrates how the system failed the patients, it has also been credited for triggering the most significant regulation changes in the EU in years. The full range and fallout of the damage remains to be seen but the efforts given to strengthening the system and the rules are positive steps toward safeguarding quality and ultimately protecting patients.
Despite the lessons that history has taught us in regards to unethical practice, human subject/patient protection continues to be a concern. In the History of Clinical Research Timeline, a document created by IMARC Research, historical cases are outlined to identify some the atrocities that have occurred in clinical research, acknowledge those individuals affected, and highlight change that has resulted. It is good reminder to all clinical professionals of the importance of protecting our patients and the difference we can make with knowledge.
What steps do you take (or have taken) or recommend to ensure patient/subject protection?
The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.