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PIP – Quis custodiet ipsos custodies?


News of the start of the PIP trial in Marseille has been widely reported. The four defendants, including PIP’s owner Jean-Claude Mas are accused of using substandard silicone in the manufacture of PIP breast implants. Mas remains defiant and, in fact, tests by the French, British and Australian governments have so far failed to identify any obvious harm from the non-medical grade silicone used. There is no doubt, however, that a substandard product that had not been approved for the manufacture was used. Additionally, there were many years of flagrant illegality and concealment, so guilt appears not to be in doubt in this respect at least.

This, of course, takes no account of the worry and distress of affected patients, many of whom underwent surgery in the midst of a media circus when factual information was not abundant. Even if not health-affecting, PIP implants in a large proportion of cases have definitely proven wealth-affecting.

One interesting aspect, highlighted by several patients, is the apparent ease with which PIP managed to circumvent Europe’s highest level of regulation over a period of several years. Furthermore, the government’s own agency specifically concerned with the safety and regulation of medical devices, the MHRA, appears to have failed in its duty to protect patients. After the prostheses were banned in April 2010, some authorities attempted to shift blame onto the surgeons who implanted them. It is worth remembering that surgeons are highly trained in their field. This field is surgery and not safety inspection of devices already assessed at an international level. They were also victims of fraud and inadequate regulation. Many surgeons worked hard during 2012 to replace PIP implants at heavily reduced fees. Such surgery generally takes longer, carries a higher rate of complications (which become the responsibility of the exchange surgeon) and is less predictable with respect to outcomes.

The entire saga reminds us of another latin phrase, which is ideal advice for any consumer. Caveat emptor translates as ‘buyer beware’ and indicates that we should all undertake sufficient research that we are happy to use a certain product, be it a car, a foreign timeshare or a breast implant. Some find it incomprehensible that the UK Government was happy to support a failing bank to the tune of many billions yet could not sanction treatment, costing only a few millions, for women who, through no fault of their own, found themselves the recipients of a potentially unsafe implant, the long-term effects of which remain unknown.