Implant statistics warning

 
A defective silicone gel breast implant, which was removed from a patient and manufactured by French company Poly Implant Prothese PIP implants were banned in 2010 as they contain unauthorised silicone filler

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I would urge caution over some of the figures for rupture rates of the banned PIP breast implants.

In the past few days there have been claims suggesting that around 7% of the implants have ruptured.

But that is misleading as it is based on one small group of patients.

The Transform cosmetic surgery group has issued a statement saying the rupture rate relates to seven out of 108 patients it fitted with PIP implants since 2005.

The statement says: "This is therefore far too small a sample to provide a robust statistical analysis."

Rupture rate

It appears to be these figures which prompted the health secretary Andrew Lansley to set-up an expert committee to review the safety data on PIP implants. The committee, which meets on Wednesday, will be attempting to determine what the overall rupture rate is among the 40,000 or so women fitted with PIP implants.

The trade body which represents private hospitals and clinics described the 7% rupture rate reported in recent days as misleading. Sally Taber, Director of The Independent Healthcare Advisory Services, (IHAS) said:

"Following an audit of our members, which includes data on thousands of patients from leading groups including Transform, The Harley Medical Group, Spire Healthcare, BMI Hospitals and The Hospital Group, we can confirm that the average rupture rates reported for PIP implants is within the industry standard of 1-2 per cent."

Last week the medical watchdog the MHRA was quoting a figure of around 1% as an average rupture rate for PIP and other implants.

This was one reason why the MHRA and health ministers decided not to follow the French lead and recommend the removal of the PIP implants.

In France, the reported rupture rate is 5%, although I have also seen reports that the rate there is 3.6%.

Tim Goodacre, president of the British Association of Plastic, Reconstructive and Aesthetic Surgeons and an Oxford University lecturer said even a rupture rate of 1% would be high:

"If you have an implant the likelihood that you will need follow-up surgery is about 1% per year. But that can be for a whole range of reasons. Ruptures of implants are, in my experience, rare. After 10 years 10% of women will have needed follow-up treatment, but 90% will not."

Mr Goodacre is one of a number of surgeons on the expert panel meeting tomorrow.

Implant register

Several groups are calling for a registry of implants. Sally Taber from IHAS suggested this should work along the lines of the National Joint Registry.

This was set up in 2002 and records the details and outcomes of all hip, knee and ankle replacement surgery in the NHS and private sector.

A breast implant registry did operate from 1993-2006 but was eventually shut because only a small proportion of women were willing to take part in the scheme.

Sally Taber said every patient must be prepared to have their data recorded, which would need to be anonymised.

We may never know exactly how many women in the UK have PIP implants. Although clinics and surgeons are required to record information, many firms have gone out of business.

A national register of implants would allow women to get information from a central database, bypassing the firm which treated them.

Tim Goodacre agrees that a registry would improve standards: "At present we can't easily say how many PIP implants were done, where and how well. We must have traceability so that even if a company goes bust, the device can be traced."

Another surgeon on the PIP expert committee said there are no firm figures on what proportion of PIP devices have ruptured.

Fazel Fatah, president of the British Association of Aesthetic Plastic Surgeons said: "None of these figures are completely reliable or are a true reflection of what's happening. A significant number of patients do not go back to the clinic where they had their surgery if they suffer a rupture. Instead, they go to the NHS and are dealt with in the NHS. We do not know the exact rupture rate in the UK."

Mr Fatah said he believed women should plan for having implants removed. "The point is not so much the rupture rates but that the quality of the silicone in these implants is not of medical grade. Therefore, the implants are not fit to be implanted into humans."

'Moral obligation'

He said women should not be caught in the middle of an argument over who should pay for the implants to be removed, adding that clinics who carried out the surgery had a "moral obligation" to women and must not be allowed to profit from removing the devices.

About 95% of the PIP implants were done by private clinics, for breast augmentation. Many of these women are seeking urgent appointments with their implanting surgeon.

It is worth repeating that no medical organisation has found any increased cancer risk from the PIP implants compared to other devices. The authorities in France have recommended they be removed as a precaution, and not as a matter of urgency.

Andrew Lansley has given another clear indication that ministers are going to stick to their original advice that the implants do not pose a safety risk.

He denied pre-empting the findings of the expert committee - due on Friday - but said that there was still no evidence to suggest that routine removal of the implants was warranted.

If ministers maintain their position it means that women whose implants are not causing obvious problems would have to pay if they want them removed.

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

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  • rate this
    +1

    Comment number 9.

    Yes, David, imagine your wife or daughter had breast cancer and she's now walking down the street with no breasts or only one and people are whispering behind her back about her illness... Don't you think that would hurt?

  • rate this
    0

    Comment number 8.

    If anything good can come out of this situation, it is the creation of a national register of implants that would allow doctors and their patients to get information from a central database, bypassing the firm which treated them. After all, it's not exactly reassuring that so many of these firms go out of business, is it?

  • rate this
    0

    Comment number 7.

    A committee, which meets on Wednesday, will be attempting to determine what the overall rupture rate is among the 40,000 or so women fitted with PIP implants. Even if this rate is 1%, that's 400 PIPs to worry about. It was not the fault of these females. Were they told industrial grade solvent would be used?

  • rate this
    0

    Comment number 6.

    Breast augmentation in post mastectomy reconstruction, or correction of congenital defects and deformities has improved lives. Does the use of such a medical prosthesis really improve the lives of those who don't really need such an invasive procedure? I believe that all invasive procedures carry the risk of long-term complications. What are we going to discover next?

  • rate this
    0

    Comment number 5.

    David dont be mean out there has ppl with breast cancer who got this operation to get back what a sickness took away. u are a man and you cannot picture or more less feel for us...Please show empathy or dont comment at all...

  • rate this
    -1

    Comment number 4.

    Let's get back to basics here. All this concerns completely non necessary surgery, in which the procedure of putting silicone into a woman's body is done purely so the woman wishes to look "more female". This is a classic example of the human race gone mad. Simple solution to all this - don't have this surgery in the first place.

  • rate this
    -1

    Comment number 3.

    This is frustating I want the truth, I have on those implantes, my life was miserable before the implants I didn't do it for looks. I sad and I do not know what to do. I want resolution. I am in Trinidad where I do not enjoy insurance nor any fancy treatment like d Americans. Please I need the truth so that I will know what is my next step. For now tomorrow am heading to the doctor to get checked.

  • rate this
    +2

    Comment number 2.

    This seems to be another case of "private profit but public risk" - shouldn't the private sector be left to pick up the mess it has created, rather than passing the buck to the NHS - which has more important things to do than correcting false vanities. (Each private operation should have a compulsory insurance so the NHS does not have to pick up the tab when things go wrong.)

  • rate this
    +2

    Comment number 1.

    Apart from absolute necessity, which I grant you is needed in some cases - why would anybody have these fitted in the first place. They always need replacing and the replacement is usually done on the NHS whilst the first fitting is done privately. Surely there is a case for private insurance being mandatory on first fitment if it is undertaken privately.

 

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