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Breast implants scandal: Answering the questions

An implant made by French company Poly Implant Prostheses

Sarah Dunn finds out the answers to the questions thousands of women affected by the PIPs breast implants scandal will be asking.

Q. I underwent an operation using Poly Implant Prostheses (PIP) implants. According to the review, should I have them removed?

A. The government-commissioned review by Sir Bruce Keogh, NHS Medical Director, found no evidence for the routine removal of the faulty PIP implants, which were recalled in March 2010 after being found to contain industrial rather than medical-grade silicone.


The report established there was no higher associated risk of breast cancer, compared to other silicone gel implants. But it could not establish whether they were toxic or determine with the data currently available whether the rupture rate for PIP implants was any higher compared to other brands.

Q. What do surgeons working in cosmetic surgery think?

A. Manchester-based plastic surgeon James Murphy, who set up his own practice, operating out of Spire Hospital in Whalley Range last year after seven years working at The Christie, agrees with the British Association of Aesthetic Plastic Surgeons that the implants should be removed as a precautionary measure.


He said: “It seems sensible to remove them – I know if a relative or friend had them my advice would be to have them removed electively now before they cause a problem, rather than waiting to see if they cause a problem.”


He said he pays between £600 and £700 per pair of implants but that PIPs were on sale for around £50 per implant. “They were certainly an inferior product,” he said adding that removal might not be straightforward.


“It could be extremely complicated. If the implant has ruptured, and the silicone has leaked out of the capsule, you could be looking at major surgery.


“Some private clinics could struggle to provide the surgical expertise or the hospital back-up to do major reconstruction surgery.”


He added these lower-grade facilities were often linked to the use of PIP implants – since he said they were always seen as the 'budget option' in the industry.


“It's all part of the same aim of keeping overheads down,” he said.


Q. If I do want them removed, who will pay the bill?

A. If you had the it on the NHS – mainly breast cancer patients undergoing reconstruction surgery – the health service will foot the bill for both the removal of the faulty implants and their replacement, after consultation with a doctor.


Privately, Spire, BMI, MYA and Nuffield Hospitals have agreed to remove and replace PIP implants after a consultation with a surgeon.


But Transform and Harley Medical Group have refused to cover the costs. The Hospital Group have yet to say one way or the other, but a statement on their website stresses there is no evidence for routine removal, suggesting they will not foot the bill.


Meanwhile, women who had PIP implants fitted with Manchester-based Surgicare, which went into administration in 2010, are in limbo. The company was taken over by The Hospital Group but the firm says they did not inherit responsibility for any of the firm's former patients.

Q. What can I do if my private clinic refuses to pay or the company has gone out of business?

A. Sir Bruce's review said it 'expects' the private sector to take similar steps to the NHS and cover the cost of removal and replacement of the faulty implants as a precautionary measure if that is what they and the clinician agree – but does not enforce it.


The Government has said it will step in to help if a private clinic refuses based on a patient's 'clinical need'.


It also said patients whose private sector provider is no longer in practice – as in the case of Surgicare – can have them removed on the NHS. But in both scenarios they will not be replaced.

Q. If my clinic has refused to pay out and I don't meet the 'clinical need' for removal on the NHS, is there any other way I can recover the funds needed for the operation?

Andrew Young, a partner at Fentons solicitors, said he cannot take forward legal action against the manufacturer – as would be the usual course of action - since it went into liquidation in 2010.


He said women could pursue a case against the clinics under the Sales of Goods Act – since they were sold faulty products – but added that because they were unlikely to have insurance covering this type of claim, it would be hard to secure compensation.


Mr Young also predicted the end for a number of private clinics as a result of the scandal.


“When they realise they are facing a massive liability they just disappear. The directors take the money out and there is nothing left – they go under,” he said.

Q. What are the private clinics saying in response?

Transform, Linia and Harley Medical Group have hit out at the review conclusions.


Mel Braham, chairman of Harley, said the company had not found any cause for concern among its patients – despite the experience of Failsworth mum Victoria Adshead who suffered a rupture after having the implants fitted with the company.


He said the government could do the operations because it had hospitals 'at its fingertips'.


In a statement the Linia clinic, who has said they will look at cases on an individual basis, blamed the Medicines and Healthcare products Regulatory Agency (MHRA) - the government agency responsible for ensuring that medicines and medical devices work, and are acceptably safe.


It said: “PIP implant failure is not an issue of poor surgical performance or unsatisfactory after-care.


“It is an issue of massive regulatory failure by the government and its agencies. We used implants approved for use by MHRA.”

Q. What are the costs involved in removing and replacing PIP implants?

One private clinic is now advertising removal of PIPs for £2,700, which increases to £3,200 if the implants are replaced with a high quality brand.


Transform has said its PIP patients would have to pay £2,800 for removal – and claimed they were making no profit on the figure.


It has been estimated that the total bill for removing all the implants could reach £150m.

Q. Why have governments in different countries recommended different approaches?

A. France, Germany and the Czech Republic have all recommended routine removal of the PIP implants, while Australia has said there is not enough evidence to recommend they be taken out.


The review says higher rupture rates of five per cent could have been found in France as a result of more PIPs now being investigated and removed. This is because some ruptures – as many as two in three – do not result in clinical signs or symptoms and therefore might only be discovered after scanning or explantation.  It has also been suggested that PIP continued to use medical-grade silicone in the implants supplied to Australia.


Q. What happens next with PIP implants and the industry as a whole?

A. In the short term, the review panel will reconvene in around four weeks' time to review any new evidence – particularly relating to rupture rates – and consider whether current advice needs to be amended.


Sally Taber, director of the Independent Healthcare Advisory Services, has asked for the re-introduction of the breast register – where details of the patient, implants, surgery and hospital are kept.


Mr Murphy said this should be the 'bare minimum' – and called for more rigorous regulation of the whole cosmetic surgery industry, such as better training in different areas, rather than people with basic surgical training being able to operate in a host of specialisms.


He said: “What has happened with PIPs reflects a general malaise that runs through our industry – somebody needs to take responsibility for standards within it.


“We will need to look at this issue as a warning to the rest of the industry.”

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my question about this whole sorry saga is this, How is it, that My grandad, who was 87, with diabetes 2 and Dementia, who also had the industrial injury, pneumoconiosis can not get NHS funding for his last 18 months of his life, which was spent in a care home. Yet a woman who privately as cosmetic surgery to enlarge her breasts, can seek and get funding from the NHS to have them corrected, when the private Hospital refuses to help? Is this the world my grandad helped to save?,

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Again, another person full of judgement, woman DONT want the nhs to pay for removal, they want private sectors to step up, woman get implants for a variety of reasons and they paid in good faith, we didnt bring this on ourselves! Also diabetes 2 is brought on by poor diet and living, why should nhs cover that then? Just saying! You people make me so angry!

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