PIP Breast Implant Alert - Updated Dec 2011

Peter Butler

You may have read about the recent PIP implant alert issued by the Medicines and Healthcare products Regulatory Agency (MHRA).

The MHRA of the United Kingdom was advised by the regulatory authority in France (AFSSAPS)  that on Tuesday 30 March 2010 it suspended the marketing, distribution, export and use of silicone gel filled breast implants manufactured by PIP (a French breast implant manufacturer, Poly Implant Prothese). It has recalled all of these devices.

The MHRA is the government agency which is responsible for ensuring that medicines and medical devices work, and are acceptably safe.

The AFSSAPS recently carried out an inspection of the PIP manufacturing plant and established that most breast implants manufactured by the company since 2001 have been filled with an unapproved silicone gel composition. This is thought to increase its likelihood of leak. It is not known if this affects the safety of the PIP implants.

The MHRA will provide further advice on patient management, as necessary, when more information is available.

What is the current advice and what does it mean in practical terms

The statement explains that the filling gel for these implants was NOT the filling gel that the company applied for a license to use.

This is clearly of great concern, however at this stage there is no suggestion that it represents a health risk to patients.

So, what should you do?

For MyBreast patients

At MyBreast we have never used PIP implants, so there is no need for you to be concerned.

 

For all other patients

1. If you have had a PIP breast implant implanted since 2001 you should consult a surgeon.

2. Your surgeon should have provided you with documentation of the type and make of implant used at the time of surgery, if you have lost this your surgeon should be able to provide details.

3. If you do not know the make of implant that has been used, you should find out from your surgeon.

4. If you have had any other breast implant used do not worry, there is NOT a problem with implants produced by other manufacturers.

5. If you cannot contact your surgeon or do not have the details of your previous surgeon and would like to discuss things further MyBreast are able to provide advice.

 

For patients known to have a PIP implants

1. If there is no sign of implant rupture, then the current advice is that removal is not required at this stage.

2. If there were a sign of implant rupture then, as with any breast implant, it would be sensible to undergo explanation.

3. The French authorities and the MHRA are continuing to investigate this problem and will provide more information when it is available - we will update this blog as soon as further information is published.

4. The PIP implant was always considered to be an inferior quality implant, and one that was prone to rupture, we have previously had to remove a number of these implants for patients who originally underwent implantation elsewhere. If you had a PIP implant removed in the past, at this stage, there is no need to be concerned.

5. We are pleased to be able to announce that the directors of our implant supplier, Nagor http://www.nagor.com/products/index.html, have offered to provide a free replacement implant to any patient with a ruptured PIP implant. To book a consultation to discuss advice for PIP patients, and hear to about our replacement package for suspected rupture, please call us on 0870 780 4000.

 

For patients about to undergo breast augmentation

1. All surgeons in the UK and France have been advised to quarantine any PIP implants - they should NOT be used under any circumstances.

2. We understand that the manufacturers and suppliers are recalling all implants in the UK and France.

3. It is not clear whether this advice is being adhered to in all countries. If you are travelling abroad for your surgery please ensure that you ask for full details of the type of implants that are to be used. PIP implants have always been known to be a cheaper, but poor quality option, for this reason they have often been the implant of choice for many “cut price” clinics. So, if you are being offered a cheap package check the details carefully.

4. If a surgeon is not prepared to give you clear indications of the implant proposed DO NOT agree to surgery.

FURTHER INFORMATION

• If you wish to see a MyBreast surgeon for advice please call us on 0870 780 4000.

• Check the MHRA website - http://www.mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON076499

• Check the MHRA update - http://www.mhra.gov.uk/NewsCentre/CON137888

Categories: Breast Surgery

11 comments

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  • Norman Waterhouse

    22nd July 2013, 11:48am

    Dear Charlotte,
    I can understand that the asymmetry is causing you anxiety. You don't say whether the change is recent or is getting worse?
    In general, it is true that breasts NEVER match and all girls have some degree of asymmetry.
    However, it sounds as though you have quite a significant difference. If it is changing or increasing, it may be that you have a collection of fluid called a seroma, which can occur years after surgery.
    Really, you need to be assessed by a doctor to assess the significance of the problem. You will probably need an ultrasound examination to determine the state of the implants and whether there is any leakage or fluid around the implant.
    I hope that's helpful.
  • charlotte godwin

    18th July 2013, 7:54pm

    hi
    I feel uncomfortable with my left boob as it is smaller then the right and I don't mean a little bit. I mean way out of size my areola on the right is the size of a 50p and the left is the size of a 10p and the boob its self on the right I cant fit in my hand. but the left is smaller then my hand
    WHAT SHOULD I DO?
  • Sam H

    22nd October 2012, 1:22pm

    Thanks for the information Peter, it's about time that the mass confusion surrounding PIP implants and <a href="http://www.westbournecentre.com/breast-enlargement">breast enlargement in Birmingham</a> was cleared up.....
  • Peter Butler

    19th October 2012, 4:29pm

    Dear Katie, the simplest way to tell whether your pip implants are leaking is to have an ultrasound. This is a relatively simple and cheap procedure and may very well be offered by the NHS if you contact your GP.
  • Katie

    2nd June 2012, 7:13pm

    Hi
    I have the pip implants how do I know if they are ok and not leaking would I be able to tell and how can you get them checked out
    Thank you for your time
    Katie
  • Peter Butler

    31st May 2012, 4:03pm

    Dear Leanne,
    I'm not sure why you are unable to have a consultation with your original surgeon. My advice would be to see your GP as whether the implants are intact or ruptured can be determined by ultrasound examination.
  • leanne tyro

    30th May 2012, 12:37pm

    Hi, i have confirmed PIP implants and am not sure weather they are ruptured as i have been offered no support whatsoever nor do i have the means to pay for private surgery at this point. I am really concerned about the effects on my physical health and subsequently very anxious about what to do next. i have been offered no support at all from my surgeon. could you call me please to discuss this? i would be really grateful. thank you.
  • Peter Butler

    13th February 2012, 4:33pm

    Dear Caroline, you do not say whether your implants were carried out with MyBreast or not. If carried out with MyBreast, I can assure you that they were not pip as we have never used them. If your implants were carried out with another provider you will need to contact them for all your details.
  • caroline dunn

    12th February 2012, 10:03pm

    iam trying to find out if my in plants are pip or not can you help me please
  • Peter Butler

    18th January 2012, 4:07pm

    Dear Julie,
    Obviously we are not in a position to know whether you have pip implants. You would need to check this with the surgeon or the hospital which carried out your operation.
  • julie winwood

    17th January 2012, 9:45pm

    hello there me have implants in, and im very sure that me have the pip implants please can u let me know im very worried now

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