PIP Breast Implant Alert - Updated Dec 2011
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.
• 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