Murky Devices: The PIP Breast Implant Scandal

PIP ImplantIn March 2010, French company Poly Implant Prothèse (PIP), a manufacturer of silicone breast implants since 1991 and one of the main producers of silicone breast implants for Europe and Latin America, was implicated in a scandal over a high rate of implant ruptures and use of substandard silicone. PIP had been using industrial-grade silicone in place of or mixed with medical-grade homologated silicone for over a decade. PIP implants were removed from the European Union market once the allegations were substantiated. In December 2013, PIP owner Jean-Claude Mas was found guilty of fraud, and an investigation into bodily harm from the PIP devices is ongoing.

A 2013 report from the French National Agency for Medicines and Health Products Safety (L’Agence nationale de sécurité du médicament et des produits de santé, ANSM) highlighted that estimating the health risks associated with PIP implants is difficult due to the variable composition of the silicon batches used in manufacturing. The higher rupture rate of PIP implants nonetheless correlated to an increased risk of skin irritation, inflammation, and a silicone-specific tissue response called siliconoma, in which nodules form in response to silicone leakage.

The state response to the PIP scandal was varied and haphazard in terms of patient protections and reimbursements. There were an estimated 30 thousand women fitted with the PIP implants in France, and about 47,000 women in the U.K. The French government paid for free removal and replacement (with another type of implant) in public hospitals for reconstructive surgery patients. Cosmetic surgery patients had access to free removal but no reimbursement for substitution. In the U.K., the National Health Service (NHS) was responsible for the removal of the implants whether inserted in the private or public sectors, but re-implantation was covered only for patients whose initial surgeries were done through the NHS. Rather than taking a proactive approach to the removal of the faulty implants, the U.K. focused its explantation efforts only on patients showing symptoms, including anxiety.

When the PIP scandal exploded in France, I was just starting a comparative research study on post-mastectomy reconstruction and cosmetic surgery in France and Italy. During my research, I met several members of one of the organizations providing resources and information to PIP victims and helping to coordinate a lawsuit. In addition to financial and other concerns from cosmetic surgery patients who were not legally entitled to re-implantation, some breast cancer patients who were technically entitled to free implant removal and replacement were unable to access it due to a bureaucratic glitch.

In France, breast cancer patients are entitled to free reconstruction in public hospitals. However, those who are unable to get an appointment end up going to private clinics and paying out of pocket. Patients entitled to both reconstruction and removal of the substandard implants also become ineligible for explantation if their initial surgeries were done in the private sector. After paying for their own, theoretically covered, reconstructions these women are obliged in some cases to turn once again to the private sector to pay for re-implantation following the removal of rupture-prone implants. The lack of uniformity in the government’s response created private pockets in a public system, leaving women who were already facing economic instability especially vulnerable.

The Silicone Breast Implant Controversy in the U.S.

PIP never sold silicone implants in the U.S. and instead entered the saline implant market in 1996. At that point, the FDA did not require safety trials for saline implants. When the FDA decreed in 2000 that saline implants needed safety trials, PIP failed them and was denied authorization to stay in the U.S. market.

Even without PIP, the U.S. had its own silicone implants saga beginning in the 1980s and reaching a high point in the 1990s. After individual lawsuits in 1984 and 1991, in which plaintiffs received damages in the millions, a class action lawsuit was initiated in 1992, involving 440,000 women with silicone breast implants who had health problems such as connective tissue diseases, rheumatoid arthritis, and other autoimmune diseases. Focusing on possible systemic health risks, the U.S. Food and Drug Administration (FDA) introduced a precautionary moratorium on the implants in 1992 that ended in 2006, as subsequent epidemiological studies found no clear link between the silicone implants and the development of autoimmune diseases or cancer [1].

As of 2013, the FDA acknowledged local complications and adverse outcomes such as asymmetry, breast pain, tissue atrophy, capsular contracture, reoperation, implant removal, rupture or deflation of the implant, wrinkling, scarring, pain, infection at the incision site and others, and that the implants often need revision within 10 years. While the U.S. debate stayed focused on the health risks associated with medical-grade silicone implants, the French investigation ascertained that PIP implants were in violation of professional and legal codes, thereby endangering health through explicit negligence and fraud.

A New Chapter in the Silicone Breast Implants Saga

The recent PIP scandal opens several lines of inquiry.

First, the inconsistent composition of the silicone gel, which varied from batch to batch, makes it difficult to monitor long-term health effects. Moreover, there are few epidemiological studies about health effects and the trial against PIP for bodily harms and manslaughter, which should establish legal damages, is still in the investigation phase. This leaves many patients feeling helpless and abandoned when dealing with the risks and uncertainty surrounding the PIP implants, as doctors themselves are unable to offer adequate answers about long-term safety.

Second, the PIP scandal provides a vantage point from which to reflect on the risks of breast surgery in general, and in particular for breast cancer patients for whom implantation is presented as a safe and in some ways optimal reconstructive option. The aftermath of PIP exposes a vital need to acknowledge limits to informed medical decision-making and management of risk, especially when safety controls are not in place to protect patients’ health.

Third, the PIP case underscores how government responses to health emergencies should address the needs and vulnerabilities of all affected patients, not just an arbitrary subset that meets state-determined criteria.

Further research on the effects of PIP would shed light on the implications of the current organization of breast cancer treatments and breast surgery. While the PIP fraud operated on a global scale, the response in each country was different (See World Health Organization documents). Thus, it would be important to hear the voices of women who received PIP implants in contexts different from France, such as the U.K. and Latin America.

[1] For a good synthesis of the evolution of the silicone breast implants controversy, see Hersch, J. (2002). “Breast Implants: regulation, litigation, and science.” In W. Kip Viscusi (Ed.) Regulation through litigation, Washington, DC, AEI-Brookings Joint Center for Regulatory Studies, pp. 142-177.

 

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