Part 1: Treading the Line

The recent alarm over use of sub-standard breast implants has exposed serious flaws in the European health regulatory system. But leaders must ensure that they strike a balance between managing risk and stifling innovation in coming up with a better model.

Nearly two years ago, in March 2010, the French health regulatory authorities conducted a non-routine inspection of a manufacturing facility operated by the French company Poly Implant Protheses (PIP). As we all know from the extensive coverage of this story over recent weeks, the now bankrupt manufacturer, once the third largest producer of breast implants in the world, was found to have been substituting approved medical-grade silicon for a cheaper, industrial-grade product called Baysilone – a material more commonly used as mattress filler. News of the finding was quickly disseminated across the decentralised European health governance system and at the end of March 2010 the UK Medicines and Healthcare products Regulatory Agency (MHRA) advised surgeons to cease use of the illegal and potentially dangerous implants.

In total, approximately 150,000 women, primarily from Europe and South America, are thought to have received PIP implants since their approval for sale in 2000. The company is believed to have been using illegal silicon since 2001.

Perhaps unsurprisingly – we are talking about mattress filler, after all – concerns about the safety of the implants had been long-standing within medical circles. In 2006, authors of a case report documenting the rupture of a PIP implant in the influential Journal of Plastic, Reconstructive and Aesthetic Surgery (impact factor 1.6) warned that “high cohesive gel implants may not be as safe as is commonly believed”. Indeed, in 2008 the MHRA felt concerned enough to ask some questions about the apparent increase in the rupture rate of PIP products. Regrettably, however, the company’s explanation that this was due to increased sales and improvements in the reporting of adverse events was accepted and no further action was taken.

So, given the warning signs, how did such blatant violation of the rules take so long to uncover? And why is the data surrounding the use of an industrial chemical as a breast-enhancer so limited when hundreds of thousands of women have unknowingly lent their bodies to the investigation of just that topic?

The answer lies in the current system of regulation for medical devices.

In order to market a medical device in Europe, a company must affix a CE mark indicating that the product reaches the necessary safety standards. Fair enough, you might think. However, even for high risk Class III medical devices such as breast implants, limited clinical data is required to prove safety or efficacy – which is why PIP failed to obtain approval in the US – and little if any quality monitoring is performed once a product has made it to market. National health governance agencies such as the MHRA have limited direct involvement in the regulation that does exist, delegating much of the work to over 80 private “notified bodies” which are responsible for approval, and relying on the manufacturers themselves to report any adverse effects resulting from the use of their products.

So, in a nutshell, the process relies on all medical device makers (and there are a lot of them), acting ethically and responsibly at all times, ignoring the potential cost savings available from cutting corners after approval and honestly reporting adverse events, even if this might lead to bankruptcy. How could this ever go wrong, we might ask?!

This system is a far cry from the equivalent governance process applied to other medical products such as drugs, where a notoriously long-winded series of regulatory hoops is accused by the industry of smothering innovation. From 2000-2005, the median time taken for the European Medicines Agency (EMA) to approve a drug was sixteen months, a delay that is expensive both for cash-strapped drug-makers and for suffering patients.

Sometimes, of course, the price of careful vigilance is well worth paying – the 60 year-old thalidomide tragedy remains our reference case for drug development gone horribly wrong, and we probably have the current system to thank for that. But the products covered by medical device legislation are laughably broad, covering everything from bandages to pacemakers, with surprisingly little variation in regulation across the spectrum. So, while further care is obviously needed in some areas, it would be a sad waste to sacrifice potentially life-saving innovations for the sake of super-safe elastoplasts.

Preventing another PIP scandal is not about adding more regulation across the board; it’s about tweaking what’s there and making it more effective, and if recent events have taught us anything they should have taught us that good data is essential in working out how best to react to a crisis. We still don’t know the health implications of inserting industrial silicon into the body because no one has been measuring them, and no one ever will if the burden of post-market surveillance falls solely on the supplier. The answer lies in finding a balance that offers a commercial environment in which companies can innovate, while taking sensible measures to ensure that dangerous products don’t make it to market. A clunky model that introduces further delays while ignoring the importance of post-market data collection is doomed to fail, both medically and commercially.

And that is a high price to pay indeed.

Next week – Part 2: Footing the Bill
Next week I’ll look at the financial impact of the PIP scandal, and ask the question: when regulation goes wrong, who should pay?

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