Firm which did biggest number of PIP implants says it won't replace them free

 

Mel Braham, Harley Medical Group: "We don't have the resources to re-implant"

"Inspiring Confidence in You," says the poster in the reception of the Harley Medical Group clinic in central London.

But in my view the firm's refusal to replace the implants of women who it fitted with PIP implants will hardly do that.

When I spoke to chairman Mel Braham in the company's first interview he said the company did not have the resources, the operating theatres or the surgeons to provide the replacements.

The company carried out by far the largest number of implant operations using PIP implants - 13,900, between September 2001 and March 2010.

Harley Medical Group has 31 clinics in the UK and Ireland and says it does around 2,000 breast augmentation operations a year.

Mr Braham told me its turnover was around £25m last year and it had made an operating loss because of the economic downturn.

Ministers say private firms have a moral responsibility to replace PIP implants free of charge if that's what women want. But Mr Braham said it was ministers who had the moral responsibility "as they had inflicted the problem on clinics, surgeons and patients".

How so? Well Mr Braham said the medical regulator the MHRA had failed to ensure that the PIP implants were safe.

He said: "This is a massive problem created by the government's agency (the MHRA) and they must accept moral responsibility and they must do something for patients. We are not geared up to do this level of surgery, but the NHS is."

The implants had a European CE mark of safety - similar to those handed out to toy manufacturers. But the safety tests are not nearly as strict as those governing medicines. The BBC radio 4 programme "Inside Health" dealt with this issue.

The regulation of medical products is something which will be analysed by the review group led by Professor Sir Bruce Keogh, medical director of the NHS.

It is the MHRA's responsibility to act when safety issues surrounding implants emerge. It says it did, although there has been criticism from other quarters too.

Richard Horton, editor of the Lancet medical journal, said surgeons began publicly to express doubts about PIP implants in 2006 but the MHRA took a further two years to note concerns.

He said, "The only reasonable conclusion can be that the MHRA failed to do the job the public expects of it - to protect it from harm. "

The Harley Medical Group says it has been trying without success to have a meeting with the Department of Health.

The NHS in England will remove PIP implants if firms refuse to do so, but in Wales ministers says the health service will remove and replace them.

The Harley Medical Group said it would provide free replacement implants to the NHS, but Andrew Lansley seems certain to reject this.

One source at the Department of Health in London told me that the Welsh position and the offer from the Harley Medical Group went against the principle that the NHS did not do cosmetic surgery.

Another major provider of PIP implants, Transform, has also said it will not replace implants for free. Like the Harley Medical Group it says it will do the surgery for cost - up to £3,000.

Some firms which did a small number of PIP implants, BMI Healthcare, Nuffield Health and Spire have said they will remove and replace them free of charge.

This is a highly confusing situation for women. Whether they get their implants replaced now depends not only on who did their surgery in the first place, but also on where they live.

And don't forget that the official advice in the UK is that there is no medical need to remove PIP implants. The safety review by Prof Keogh was inconclusive - in part because the data on implant ruptures was patchy.

The PIP implants contained industrial grade silicone which did not undergo medical tests. So there are no guarantees about its long term safety.

But the recommendation that implants be removed by authorities in France, Germany and elsewhere is not based on strong evidence of harm but rather the potential that there could be problems in the future.

Women will have to make a judgement - do they want the implants removed as a precaution - bearing in mind that any surgery carries an element of risk?

It is an unsatisfactory situation for any patient to be in. More than 9,000 women in the UK had the surgery last year and I wonder whether the adverse publicity will lead to fewer breast enhancement operations in future - which would be one positive development from the PIP scandal.

 
Fergus Walsh, Medical correspondent Article written by Fergus Walsh Fergus Walsh Medical correspondent

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Comments

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  • rate this
    +3

    Comment number 1.

    If big companies chose to maximise their profits by using sub-standard components, the shareholders and the company execs should hang their heads in shame - they MAY have put patients at risk, therefore they should act ethically and do the right thing ! shows why they are in private 'health' care!

  • rate this
    0

    Comment number 2.

    Hi I made a short documentary about the dangers of implants. The film includes an interview with a young girl who's PIP implants ruptured. http://vimeo.com/29670374

    Jenny

  • rate this
    +5

    Comment number 3.

    The manufacturers, the clinics / healthcare organisations, and the surgeons will all have had indemnity arrangements in place; however they will not want to admit this as their premiums will go sky high ...

  • rate this
    0

    Comment number 4.

    I believe due to the fact that MHRA had at the time licensed the PIP implants for use in the UK then that department is responsible. The cost of removal and replacement lies at their door. The NHS and private clinics have used these implants as a licensed product. The government should be working with private clinics to plan how and when the replacements can be fitted.

  • rate this
    +3

    Comment number 5.

    I fail to see how this is the fitter's fault. The item fitted was manufactured and subsequently approved by a British body. Now the approval looks to have been inappropriate it should be the body that approved these as safe who funds the replacement - otherwise why would they ever invest in testing? All they need do is say 'yeah, that's grand' knowing there's no recourse!

 

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