Breast implants

[womanofdulwich]

I dont see why the NHS should replace these if they wsere put in privately. They are fundamentally not right- they will all need replacing at some stage and if the NHS had not done them in the first place they should not put anything back in. What do you think? What about having them taken out? should the NHS help in taking them out? Do you think that this will influence the demand for breast implants?

[El Pibe]

I think it makes sense that the NHS remove them, as they are potentially life threatening, that's what the NHS is there to do, save lives.

Replacing is another matter.

But I guess if the private boob folk pay for their own replacements it can't take that much longer to put them in whilst you're taking them out can it?

[Marmora Man]

Some thoughts from me - someone, almost, in the eye of the storm. I'm currently managing a large private hospital (Interim Managment turnaround contract) for a group that has not used any significant number of PIP breast prothesis (approximately 150 patients over ten years of the > 40,000 reported cases in UK.

The group was first to state they would explant and replace any PIP implants free of charge and has been central in providing advice to worried women and in proposing new rules and regulation around this aspect opf cosmetic surgery. The other major independent sector providers have behaved in a similarly ethical fashion, tho' the smaller specialist cosmetic surgery providers haven't. With my team we're just working out how to support 63 women with PIP implants, for soem of whom the oruiginal surgeon and hospital is no longer available.

My thoughts on who pays - it's an interesting conundrum.

The absolutists - as per OP: Their choice, their risk, their cost is a understanable argument. My libertarian instincts kick in and sees the logic of this argument.

The rationalists: The NHS exists to provide healthcare, free at the point of care, to all regardless of how or why the problem occurred. Alcoholics requiring liver transplants, promiscuity leading to sexual health problems, smoking leading to lung cancer could all be seen as self created problems - but the NHS looks after the patient. So this element says it is right for the NHS / gov't to pick up the cost.

The legalist: The various cosmetic surgeons and the dodgier cowboy clinics were using what were "kitemarked" protheses approved by government agencies so had good reason to believe they were safe and appropriate - albeit suspiciously cheap. This argues that it's a failure of regulation and thus the cost should fall to gov't.

On the whole I come down on El Pibe's side to do otherwise is to question the NHS commitment to no blame treatment. However, I would also expect the NHS and / or others providing free care and support to make claims on either the original manufacturer (difficult - it's bankrupt) or the government as the failed regulator.

[El Pibe]

"I would also expect the NHS and / or others providing free care and support to make claims on either the original manufacturer (difficult - it's bankrupt) or the government as the failed regulator"

very good point.

[womanofdulwich]

Don't you think the Harley Street place are shootign themwlves in the foot? I guess they can close and reopen under another name but they are reacting so badly to this its frightening. I would have thought they would be offerign somethign at a non profit cost just to restore confidence. Surely they could be offering something to these poor women. Its is frightening the lack of regulation. If the implants were so much cheaper than other ones would you not sniff there was something wrong?

[Undisputedtruth]

The private clinics have a moral duty to resolve PiPs and I'm shocked by their blame game tactics. They took the money from the women to perform the operations and yet offers no safeguards if anything goes wrong.

Sorry but the private clinics do not deserve to be in business if their business plan does not cover risk management.

[El Pibe]

That's actually an interesting wider question WoD, people being notoriously bad at making risk based decisions.

I wonder how many people given the frank choice

a) ?16k and is 99.6% safe over a ten year period due to pricey expensive human tested poymers or

b) ?4k and 80% safe over a ten year period due to cheap industrial polymers

how many people would still opt for b. I suspect it'd be higher than we might expect.

[Marmora Man]

For info - a 10 point plan put forward by an Independent Healthcare Operator. Point 10 is a very sensible proposal.

1. ????The guidance for all medical devices to be re-examined to ensure patients can be tracked quickly and effectively if concerns are raised around any implants they received.

2. ????Standardised data collection methods to be used to improve outcome data.

3. ????The government to reintroduce a National Implant Registry for all breast and other cosmetic implant medical devices (as with the hip, knee and ankle registries). ?

4. ????A review to take place of all other voluntary registries (such as the bariatric surgery registry) and consider extending to other implants (such as pacemakers and cataract lenses).

5. ????The introduction of standards for patient information and informed consent with ?cooling off? period for all cosmetic surgery.

6. ????International collaboration to allow monitoring of the issues and complications which can arise from breast implant surgery.

7. ????A review of the actions and guidance provided by the MHRA on PIP implants and of the CE marking scheme for medical devices.

8. ????The MHRA to make it clearer to doctors on how to report issues with medical devices. ?

9. ????The implementation of wider safeguards for patients of all cosmetic treatments, injectables, fillers and medical lasers. ?A ban on direct consumer cosmetic advertising (as exists for medicines). Fillers to be reclassified as prescription-only medicines. Deregulation of lasers to be reversed.

10. The consideration of an industry ?bond? scheme (along the terms of ABTA / ATOL in the travel industry) where all cosmetic providers are required to provide a guarantee scheme to protect patients. ?This must include the provision of hospital facilities and follow-up to manage complications, longer-term follow-up and specialist care when required by patients.

[Carter]

The regulations or lack thereof is an interesting point in this sorry debarcle.

The Conformit? Europ?enne (CE) mark is formally the EC mark and is the mandatory conformity mark for products placed on the market in the European Economic Area. Thus, under EU law the MHRA is obliged to permit the import and marketing of any device which bears the mark even when it has no jurisdiction over the manufacturer - French in this case.

Unless it has direct evidence to suggest that there might be something wrong, the MHRA is not even allowed to carry out its own tests to ensure that imported products bearing the CE mark conform with the required standards.

The MHRA has of course its own regulations but these simply implement EU Medical Devices Directives and amendments, specifically the Council Directive 93/42/EEC of 14 June 1993 concerning medical devices. Breast implants are covered by the Directive, the applicable standard being EN ISO 14607:2009 which refers to "Non-active surgical implants - Mammary implants". The particular requirements are set out in ISO 14607:2007.

The private clinics have a moral duty to resolve PiPs and I'm shocked by their blame game tactics. They took the money from the women to perform the operations and yet offers no safeguards if anything goes wrong.

No, they do not. The fact these faulty implants have been fitted is not the fault of the clinics. Fitting implants can cover any manner of reasons including illness, cancer, accident and of course vanity. They were using EU approved surgical implants and the MHRA had no power at all.

If anything the regulatory failure is at EU level. The NHS should remove or replace these implants if needed, but in the first instance should be looking to recover costs from the french, or the EU themselves.

Edit to add - I have a personal interest in this. My Mum had a mastectomy 3 years ago due to breast cancer and is directly affected by this. Her clinic has been in very close contact with her and has been very supportive. Since the French firm that produced these implants has now closed down, we are examining all options.

[The Gastric Band]

A relative of mine has had the P.I.P's . Even she beleives that the NHS should not have to foot the bill for replacements.

[Marie81]

I think the private clinics that put in the PIP implants should be the ones to remove and if wanted by the client replace them. It's wrong for the private clinics to refuse to do this which I believe some of them are!

For the people who has this done on the NHS well then the NHS should be responsible for removing/replacing them but I don't think it should fall on the NHS to do this for the clients who went private in the first place.

I personally think it's wrong to go to the NHS for a boob job to make them bigger! If you want them larger for no other reason than you just want them then you should have to go private and pay for it. I think if you having problems with large breasts then yes the NHS can step in and offer a reduction. The same with people going to the NHS for lipo, I know someone who's doctor referred them because she said she was feeling down about her baby weight she put on when pregnant. Why should the NHS do this for her?!

[indiepanda]

It's a difficult one - it should really be the makers that pay, but I gather the company has gone bankrupt.

From what I have read, it sounds like the company quite deliberately used industrial grade silicone to cut costs and when inspected deliberately showed the inspectors some samples that were using the correct grade. Perhaps random tests should have been carried out of those supplied to clinics rather than just ones at the factory? In the event of deliberate deceit that's the way to find out about it.

I am not sure it would be reasonable to have expected the clinics to carry out their own tests to find out they were not the quality they should have been, they should have been able to rely on the tests carried out by the inspectors, and if you accept that view, it seems a bit unfair for them to have to pay - some will just not be large enough to be able to afford to and I wouldn't mind betting their insurers will find a way of wriggling out of paying up.

Part of me thinks the NHS shouldn't have to pick up the cost for fixing cosmetic surgery as the individual chose to have the surgery, putting themselves at some risk (albeit they didn't appreciate how much). However, if you take that view to the limit, it's been well known smoking is carcinogenic for many years, but the NHS doesn't refuse to treat smoking related cancers. And most (I know not all) cancers are in part related to lifestyle factors - so where do you draw the line?

I think ensuring women have the right to get them removed via the NHS if their clinic cannot and chasing the EU / French for compensation is the right route to go.

However, I don't think it's the NHS's job to provide replacement implants in the case of those who had the surgery done for cosmetic reasons privately. Perhaps that's where the clinics should come in. - they fund the cost of the replacement implants and the NHS deal with the surgery to remove the dangerous ones, replacing them only where someone is willing to pay for it.

I wonder if this will make people consider more carefully the risks involved in cosmetic surgery?

[sam&jemima]

i agree marie81.

[Saffron]

Private clinics should have been insured for this kind of problem. Are private clinics allowed to practice without this kind of insurance? I'm mildly surprised that this isn't regulated! Even though it's cosmetic, it's still medical.

Also, if the NHS removes PIP implants but doesn't replace them with a suitable implant, how then do they respond to the issue that leaving an "empty" space in the breast tissue can cause clinically relevant health problems due to the build-up of fluid etc in that space. If practitioners are sworn by oath to "do no harm", it would seem that replacing the implant would be the safer option.