PIP Implants and Responsibility

http://www.guardian.co.uk/commentisfree/2012/jan/11/breast-implant-private-health-regulation-nhs?INTCMP=SRCH

As we have all seen, or read, in the news there is somewhat of a controversy about PIP breast implants which use industrial grade silicon gel, that is not suitable for humans, which nevertheless has been approved and used. Now a private company which provides NHS services has used this product to a greater extent than anyone else and now seeks to blame the government for approving it. I think this is a good opportunity to discuss repsonsibility within the context of regulated products.

I find it hard to be convinced that the government should be blamed for a private company’s decision to use these products, despite them being approved.

Firstly, while governmental approval is all well and good it is not perfect and a correct decision made at one time can be found to be incorrect upon new evidence. How a government responds to this change is important and they should be held accountable. But at the time the decision was made it is hard to see where the government went wrong. And if they did not then why should they be held liable for the cost? This seems particularly true when the organisation is a private profit driven company, rather than the NHS. In the case of the NHS the government can easily step in, and should be responsible because they NHS decision to use this product could be subject to review.

The case is much more difficult with a private company, which while relying on the approval, did not have to use that product at all. It was entirely their decision and in accordance with a ‘free’ market they should be responsible for their conduct. Of course they could rely on governmental approval to protect themselves from compensation or other actions, but they should not be able to us it to offload the cost of replacement. The reason for this, I think, is that they have a duty to their patients/customers and if a product is found to be faulty they have obligations to remedy the matter. They can sue the manufacturers if they wish, but the patients are their responsibility.

Additionally Richard Horton in the article linked above, argues that this will be a continuing feature of privatisation of the NHS.

Thought’s anyone?

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2 thoughts on “PIP Implants and Responsibility

  1. The UK government did not approve the PIP breast implant device. A French company – unsurprisingly now out of business – manufactured the device using the inappropriate silicon. A German company acted as the notified body and assigned the product its CE mark enabling its legal use throughout the EU. In this case, the role of the Medical and Healthcare products Regulatory Agency (MHRA) representing the UK government is one of post-marketing vigilance i.e. looking out for adverse events, product complaints. To my mind, it is the French and German organisations which are culpable here; both have acted irresponsibly, the first for using a non-medical grade of material, the second for ignoring that fact (presuming that the full technical information was included in the CE application package). The UK government is actually acting responsibly, if not in the tax payers’ economic interest, in being prepared for the NHS to pick up the tab for removal of the implants of inadequate quality in distressed cases even where the NHS was not responsible for their insertion. Wisely, they are not committing tax payers’ money to replacement implants for those whose vanity (or whatever) sent them to private ‘cosmetic’ clinics in the first place.

  2. Anthonia, thanks for clarifying the approval process. It demonstrates a difficulty in having multiple organisations involved; perhaps a single European wide agency would be an answer.

    I agree with the distinction between ‘cosmetic’ and ‘therapeutic’ implants, although it is always difficult to leave some with the ‘bad’ products when they were acting on the available information at the time.

    Perhaps it is the French and German agencies who should be heal accountable, but I still have difficulty with thinking that private companies exercising the separate profit generating activity should be able to blame someone else for their own decisions.

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