FORTY thousand women are affected by the industrial-grade silicone breast implant scandal in Britain alone, and now recriminations are flying between the government, the manufacturers and the regulatory bodies over who will pay for the replacement surgery involved.
Ninety-five per cent of the implants were inserted by private clinics, but the Harley Medical Group on Thursday insisted they would not replace them free of charge.
Health Secretary Andrew Lansley told parliament that the NHS would remove, but not replace, them free of charge.
Meanwhile, the manufacturers’ organisation said that any outstanding moral and ethical obligation lies with the Medicines and Healthcare products Regulatory Agency (MHRA).
As a result, the NHS is loaded up with costly surgery at the same time as its funding is savagely cut, while the money-grubbing private sector which caused the problem is merely called upon to exercise its ‘moral duty’ by Lansley!
Richard Horton, writing in The Lancet on January 12, brought these questions out in the conclusion to his analysis of the Poly Implant Prostheses (PIP) scandal:
‘One final concern. The UK Government’s Health and Social Care Bill will open up the NHS to private sector providers. The events of the past month show why this policy is so misguided.
‘When something goes wrong in the NHS the entire organisation can be mobilised to address the problem coherently, transparently, equitably, and to the very highest of standards.
‘In the case of PIP implants, over 95% of which were done by private providers, what have we seen?
‘Mr Lansley has had to castigate private cosmetic clinics for failing to gather and provide high-quality data on their procedures.
‘The best he could do was ask that they “take similar action” to the NHS; he could not require such action.
‘Bruce Keogh, the medical director of the UK’s NHS, went further: “we can place no reliance upon (their) figures”.
‘Yet this is the future for the NHS.
‘A system of health care that cannot be held accountable by government, one that has no obligation to collect or supply accurate information about what it is doing, one that fiercely resists its duty of care to patients, and one that is more concerned with cost than it is with quality.
‘The evidence is before us: it’s time to kill this Bill.’
The rest of Horton’s article began by praising Bruce Keogh for his interim report on Poly Implant Prostheses (PIP) of January 6th.
‘…his report also reveals an astonishing regulatory failure. It identifies weaknesses in UK health decision making.
‘And it shows why opening up the NHS to private providers is such a dangerous and ill-considered venture.
‘Breast implants in the UK are regulated under an EU medical devices directive. The PIP implant was approved in 2000 on the understanding that it used medical grade silicone. Exports to the UK began that year.
‘The Medicines and Healthcare products Regulatory Agency (MHRA) first noted concerns about the PIP implant in 2008. This was two years after surgeons had begun publicly reporting their own anxieties about these prostheses.
‘In 2007, R B Berry wrote: “That a high cohesive gel implant could have suffered such a massive failure only three years after implantation is very worrying and, in this case, not only had silicone migrated to a regional lymph node, but the exposed silicone gel appears to have provoked an inflammatory response with the production of a significant quantity of serous exudate.
‘“In view of these two reports the reliability of PIP implants must be questioned and, for myself, I intend to discontinue their use in favour of implants from other manufacturers.”
‘Did the MHRA read this report?
‘If not, then what is the point of an agency that does not keep up with safety signals reported in the medical literature?
‘If it did, then why did it not order an urgent safety review?
‘The only reasonable conclusion can be that the MHRA failed to do the job the public expects of it — to protect it from harm.
‘In December, 2011, the French regulatory authorities advised women, based on their assessment of the evidence, to consider removal of their PIP implants.
‘The MHRA responded on the same day (December 23) by disagreeing with their French counterparts. The MHRA argued that it did “not believe that the associated risks of surgery from breast implant removal can be justified without further evidence”.
‘This judgment was hasty, cavalier, and completely counter to ongoing concerns about PIP implants…
‘The government had told women who had received PIP implants “not (to) be unduly worried”. But that view was quite literally incredible given that women had received implants containing an industrial-grade silicone gel that was not approved for human use.
‘Women should certainly be worried that regulatory procedures in place in the EU and UK have failed them so spectacularly.’
The Lancet editorial of January 12 on breast implants reported on the experience of regulation in the US. It points out that:
‘In April, 1992, FDA Commissioner David Kessler imposed a federal moratorium on the availability of silicone breast implants. They were only to be used for reconstructive (medical), and not elective, purposes until their safety was proven.
‘The next 14 years was an era of divisive and acrimonious litigation (including the biggest US class-action lawsuit in 1995 of US$4.3 billion) — as well as publications in peer-reviewed journals and a 400-page Institute of Medicine report in 1999 — all failing to link systemic disease with silicone breast implants.
‘The ban on implants was lifted in 2006 and since then just two manufacturers, Mentor and Allergan, have supplied the US market. Part of the FDA’s decision depended on manufacturers conducting large post-approval studies following 40,000 women for 10 years after receiving breast implant surgery.’
All of which, says the editorial, raised the question ‘How safe is safe enough?’
‘Kessler put it this way: “The role of the FDA is not to prove a device to be unsafe before it can protect against its use, but rather the US law states that safety first is to be demonstrated by manufacturers.”
‘The FDA rightly sees itself as a protector of the American people.’
The Lancet calls for a mandatory national registry of silicone-gel breast implant recipients and that regulators ‘ensure that manufacturers complete post-marketing safety studies’.
‘Here are absolutely vital lessons to learn for governments, regulators, and the professions in Europe,’ the editorial concludes, noting that women should expect nothing less than safety and the prevention of further crises.
