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

Fergus Walsh
Medical correspondent

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Media caption,
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.