Professionalism/PIP and Silopren

Background

Poly Implant Prothese (PIP) was a French company founded by Jean-Claude Mas in 1991. PIP is infamous for their silicone gel breast implants which were sold primarily to European, Latin American, and Australian women.

Timeline

In 1991, PIP received French health ministry approval for their silicone gel breast implant. Their silicone was required to be purchased from an external, medical grade silicone manufacturer.

In 2001, PIP illegally switched their formula from the approved externally sourced medical grade silicone to an in-house produced industrial grade silicone in the majority of its implants. This new industrial formula was around 90% cheaper and contained chemicals such as silopren, baysilone, and rhodorsil which are normally used as fuel additives or in rubber tubing. While silopren toxicology effects have not yet been determined, its safety data sheet recommends proper handling with protective equipment and immediate contacting of a poison treatment specialist if large qualities are ingested or inhaled.

In 2009, surgeons reported high rupture rates for the PIP silicone implants, in which the implant tears and the silicone gel can leak into the body. This can cause lumps, inflammation, and tissue hardening. In this case, the unapproved silicone was brought into direct bodily contact. PIP was liquidated shortly after.

In 2011, the French health ministry conducted an investigation and concluded that there is no link between the implants and breast cancer. However, 20 cases of breast cancer were documented in women with the implants, including one death in which the cancer formed directly from the scar tissue surrounding the implant.

In 2013, Jean-Claude Mas was convicted for fraud, sentenced to prison for four years, and fined 75,000 euros. Four other PIP executives were convicted with lesser sentences ranging from 1-3 years. Around 300,000 women are thought to be impacted by the faulty implants.

Who is to Blame?

Jean-Claude Mas

Mas claims to have "organized everything to escape being monitored" and that "we did it for 13 years without a problem". He allegedly told police he had ordered staff to "hide the truth" in 1993. While PIP was thought to make the switch in their formula in 2001, these statements indicate that the corruption and intentional deception of regulatory agencies may have gone on for longer. Yves Haddad, the lawyer representing PIP and Mas, blatantly states that PIP "did not formally receive the regulators' approval" and there was "a violation of regulations". When asked about the company reasoning behind their non-approved product, Haddad stated that is was "because of corporate management that tried to get the best cost". Most evidence points to corporate management, and specifically Mas, being the mastermind behind the fraudulent operation.

The Engineers

While Mas may have been the mastermind, the engineers were not completely ethical in their work. According to trial attendee Isabel Traeger, when they asked one engineer how they made their implants, he responded with "you use your best guest". This demonstrates not only poor manufacturing practices, but also reveals that the engineers knew they were not complying with medical regulations. However, former worker Eric Mariaccia claims that “the responsible ones aren’t the workers but the heads of the company". However, the workers did not comply with regulations nor conduct any pre-launch clinical trials as required by their profession.

The FDA

It is worth noting that PIP's faulty breast implants did not affect women in the United States. The reason being that in 2000, the FDA did not approve PIP's saline implant, which differs from the silicone gel implants that caused the issues in other countries. At the time, silicone gel breast implants were banned throughout the US. Therefore, PIP's only way to sell their products in American markets was through the new saline implant. The FDA investigated PIP's manufacturing plant and sent a warning letter to the company's owner, Mas, citing 11 deviations from good manufacturing processes. These deviations are related to the saline implants, which are a different line from the silicone implants. However, the plant inspected produced both types. While the FDA claimed they made this warning letter public, French authorities claim they were not informed directly. It is unknown if the FDA shared this information with France in 2000. This lack of communication is thought to have damaged PIP's anticipated revenue and potentially contributed to the company switching formulas. It is impossible to know what would have happened if France had this information in 2000.

TÜV Rheinland

In 1997, PIP commissioned TÜV Rheinland as a Notified Body to evaluate its quality assurance system. Notified Bodies assist medical device manufacturers, such as PIP, in complying with regulations and standards and implementing proper quality assurance systems. However, manufacturers remain solely responsible for the safety and quality of their products. TÜV Rheinland claimed they “acted responsibly and in compliance with all laws and regulations at any time – from the initial assessment of PIP’s quality assurance system, the examination of the design dossiers to subsequent audits… [and] Where deviations were found these were diligently followed up. At no time there was an indication of criminal or unlawful behavior by PIP”. TÜV Rheinland also stated that if PIP had manufactured its products in accordance with the reviewed design dossier and quality assurance processes, the implants would have complied with all legal requirements.

TÜV Rheinland issued a press release stating “ PIP deceived all parties involved – most importantly the patients, but also the competent supervising authorities and TÜV Rheinland”. PIP kept complete records of the use of approved implant materials and concealed any hints of different raw materials. When PIP's fraud was exposed, TÜV Rheinland immediately suspended the certificates. Despite TÜV Rheinland's defense, a French court ruled in 2021 that TÜV Rheinland had been negligent in awarding safety certificates for PIP implants. Various court orders required TÜV Rheinland to pay compensation to faulty breast implant victims.

In conclusion, TÜV Rheinland's involvement in PIP's fraudulent activity resulted in legal consequences. Despite their claim that they acted responsibly and in compliance with all laws and regulations, a French court found them negligent in awarding safety certificates for PIP implants. The court ordered TÜV Rheinland to pay compensation to victims of faulty breast implants.

Professional Ethics

Corporate Leaders and Ethical Decision-Making

CEOs and other company leaders have a duty to ethical decision-making since they play a crucial role in establishing the general tone and direction of their organizations. They should act in the best interest of their company, which includes not only customers, employees, and shareholders, but also the wider community. During Jean-Claude Mas' tenure as CEO, he made a number of unethical decisions that put the health and safety of thousands of women at risk. It was Mas's plan to shift from externally sourced medical-grade silicone to internally produced industrial-grade silicone, knowing this would make the implants significantly less safe. PIP would have continued to sell the cheap implants had they not been caught in 2011. As CEO, Mas had the responsibility to ensure that his company's product was of high quality and designed to minimize risk of harm to patients. However, he failed to do so and many women suffered because of his selfish decisions. Even after being caught, Mas showed no remorse to those affected and denied any wrongdoing.

The Ring of Gyges and Selfish CEOs

The story of the Ring of Gyges can be used to explain the conduct of self-serving CEOs. In the story, a shepherd discovers a powerful ring that makes him invisible and subsequently leads him to become increasingly corrupt and selfish, committing immoral acts without fear of consequence. The same way that the shepherd was corrupted by the power of the ring, some CEOs may become corrupted by the power of their position. When granted enormous power and wealth, these CEOs may become selfish and corrupt, as they feel invincible and above the law. This can lead them to make unethical decisions, such as engaging in fraudulent behavior, exploiting workers, or prioritizing short-term profits over long-term sustainability. In Mas's case, he pushed production of unsafe, cheap implants, ordered employees to cover up evidence, falsified paperwork, and ignored medical regulations. The lack of oversight and accountability can create a sense of impunity that encourages such behavior. This story is a cautionary tale about the corrupting influence of power and highlights the important of ethical leadership.

Leadership Virtues, Employee Ethics, and Reporting Wrongdoing

Another connection can be made between PIP and The Great Learning excerpt by Confucius. “When the self is cultivated, the family is in harmony. When the families are in harmony, the state is well governed. When the state is well governed, tranquility reins throughout the land.” However if the root is in disorder, then there will be disorder throughout the rest of the steps. This stresses the need for leaders to prioritize personal development and cultivate a virtuous character in order to govern justly and effectively. It’s clear that the leader and root in this case, CEO Jean-Claude Mas, did not do any of that, which lead to a state of disorder. Due to one man and other company leaders with the same mindset, thousands of peoples lives were negatively affected. Regulatory bodies like TUV Rheinland were criticized for negligence, doctors and healthcare professionals who recommended or used PIP implants had their reputations affected, and most importantly the patients who received the faulty breast implants, many experienced complications such as ruptured or leaking implants, inflammation, pain and even death.

Employees also have an ethical duty to report any wrongdoings or injustices within the company when they are made aware of it. PIP Employees who were complicit and agreed to cover up evidence were also at fault. Had it not been for the doctors who began reporting higher than usual rupture rates, then there wouldn’t have been investigations launched that led to the discovery of the company’s decade long fraud and corruption. No matter the position or role, employees should attempt to speak up against wrongdoing and try to bring awareness to it. Even if they are fired, it is not their fault, it is likely that the company’s foundations and virtues are flawed. A job can always be replaced, but a life lost can never be regained.