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PIP Frequently Asked Questions

Do I have PIP implants?

The only PIP implants that have been highlighted to be of any concern are those that were manufactured between 2001 and 31st March 2010.  If your surgery was with The Harley Medical Group and was between these dates it is likely you have PIP implants. To enable us to confirm this, we will need to locate your medical records.

In order to facilitate this step, please complete the PIP contact form. Please be assured that once we have your records and information confirmed, we will endeavour to contact you within four weeks so that we can be sure we are giving you accurate information.

I know I have PIP implants, what do I do now?

The advice from the Department of Health and the Medicines and Healthcare products Regulatory Agency (MHRA) is as follows:

• There is not enough evidence to recommend routine explantation (removal) of PIP breast implants

• There is no link with cancer  

• PIP implants that have been tested, show no risk of dangerous toxins leaking into the body if an implant did rupture

• A government review of all available statistics has shown that there is not an increase in the rupture rate of PIP implants compared to other makes.

What is the latest information provided by the Irish Medicines Board (IMB)?

I think my implant may have ruptured. What should I be looking for?

If you feel that you are displaying clinical symptoms such as pain, heat around the breast area, redness, inflammation or rippling, we are advising patients to please make an appointment to see your GP to discuss your concerns.

To save time we are advising patients to ask their GP for a scan which will confirm if a rupture is present.  This will ensure that when you see your surgeon at one of our clinics, they will have as much information available to them as possible. Please also ask for a copy of the scan report from the radiologist.

My GP will not arrange a scan, what should I do?

If you have clinical symptoms and your GP will not arrange a scan, you will have to obtain one privately. In all future PIP confirmation letters we will communicate the scanning process. Please bear with us and wait for that letter. We are going through the archive records as quickly as we possibly can.

Why did the Harley Medical Group use PIP implants?

PIP implants were approved as a medical device by the Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA is an agency of the Department of Health and the only authority that approves medical devices such as breast implants in the UK. The implants have since been used widely by both the NHS and the private sector.

As a UK healthcare organisation, all our clinics are registered with the Department of Health’s Care Quality Commission and we adhere strictly to the guidance of the Medicines and Healthcare products Regulatory Agency (MHRA) regarding breast implant information. We have been, and continue to be, in close contact with them regarding the situation surrounding PIP breast implants, which the MHRA approved until they withdrew them from the UK market in March 2010.  The Harley Medical Group ceased using PIP implants on the 30st March 2010.

Why did The Harley Medical Group use the cheapest implants available on the market?

PIP implants were approved as a safe medical device by the Medicines and Healthcare products Regulatory Agency (MHRA), and as a consequence were widely used by both the NHS and the private sector. PIP implants were not the cheapest available on the market. There was no evidence at the time to suggest PIP implants were an inferior product.

I’m pregnant / I am breastfeeding will my implants affect my baby?

The advice from the MHRA is as follows:

“Since the tests have shown no cytotoxicity or genotoxicity associated with the gel, there is no reason for patients not to continue to breast-feed.”

I want a copy of my PIP implant medical records.

The Harley Medical Group can only release a patient’s medical records if a signed written request has been received.  It should also be noted that a patient’s medical records can only be released to their nominated representative, if we have received prior signed written authorisation to do so.

To obtain a copy of your medical records, please write to your originating clinic.  On receipt of a signed written request the clinic will arrange to send you a copy of your medical records. Please bear with us as this will take some time.

I’ve been told you no longer have my medical records.

The Data Protection Act 1998 prohibits the retention of personal data for longer than is necessary. Therefore in line with the NHS we only keep cosmetic records for a period of 8 years

I want these implants removed – what should I do?

We take our guidance and directives from the Department of Health and the MHRA and their advice to remains that patients with no rupture do not need to have these implants removed as there is no evidence of risk to health.

My scan indicates a rupture of my PIP implants, what should I do next?

Please can you call us on 0800 022 3387 to arrange an appointment with your surgeon. The Surgeon’s appointment will be provided without charge and it would be helpful if you could please bring a copy of the radiologists report of your scan with you.

• For any patient of The Harley Medical Group with PIP implants who has a confirmed rupture accompanied by a scan within 10 years of implantation, we will remove the implants free of charge.

• For any patient of The Harley Medical Group with PIP implants who has a confirmed rupture accompanied by a scan within 6 years of implantation, we will replace the implants free of charge.

• For any patient of The Harley Medical Group with PIP implants who has a confirmed rupture accompanied by a scan between 6 years and 10 years of implantation, we will replace the implants at cost price. Please note that cost price is dependent on the type of surgery required, which your surgeon will discuss with you during your consultation.

If my PIP implants rupture within the first two years, how much will it cost?

The Harley Medical Group is in a position to replace your implants without charge.

Is The Harley Medical Group in discussion with the NHS regarding this issue and my care?

Yes, The Harley Medical Group, The Independent Healthcare Association (IHAS) and other private healthcare providers and independent surgeons are in discussions with the Department of Health, the NHS and the MHRA. We and our industry body have requested a meeting. We hope to update you on this as soon as details are confirmed.

What are the current NHS recommendations?

The latest advice from the NHS and plastic surgery experts is that women with PiP breast implants do not need to have them removed unless they have symptoms such as pain and tenderness.
There is no link to cancer and there is no clear evidence of an increased risk of harm compared to
other brands of breast implants.
However, if you are concerned, you should:

• Find out if you have PiP implants by checking your medical notes. You can get this information for free from your clinic or through your GP. If you had PiP implants on the NHS, you will receive a letter in the next few weeks.

• Speak to your specialist or GP, if you had them done on the NHS, or your clinic if you had them done privately.

• Agree what’s best for you. Get advice on whether or not you need a scan, then discuss appropriate action with your doctor.

What if I’m a Welsh resident with the PIP implant?

The Welsh government have decided that all women registered in Wales who are clinically assessed as needing PIP breast implants removed will be offered replacement implants on the NHS, regardless of whether they received the initial implant privately or from the NHS. The NHS will require evidence that women who were originally treated privately have sought redress from their private provider, evidence that the woman is a Welsh resident and registered with a Welsh GP, and a clinical assessment of their case.

If this is applicable to you, we advise you book an appointment with your GP to find out what the process will be and provide you with further instructions.  We are currently in the process of retrieving the files of all affected PIP implant patients.  Please be assured that once we have your records and information confirmed, we will endeavour to contact you within four weeks so that we can be sure we are giving you accurate information.

Please contact the Welsh NHS for further advice http://www.wales.nhs.uk/sitesplus/899/news/21522 

How is The Harley Medical Group regulated?

The Care Quality Commission (CQC) for England

The Healthcare Inspectorate Wales (HIW) for Wales

The Regulatory Quality and Improvement Authority (RQIA) for Northern Ireland.

All independent healthcare providers must be registered with the appropriate regulatory body and able to demonstrate their compliance to exacting standards and set outcomes.  The Harley Medical Group are advocates of preeminent clinical practice.  We adhere strictly to the clinical governance criteria set out by the regulatory bodies above, under the responsibility of the Nominated Individual (NI), and this is reflected not only in the service that we provide to our patients but also in our exemplary regulatory record. Since we first opened in 1983, all of our 30 clinics in the UK have passed numerous unannounced and announced inspections. We have, on a number of occasions, received commendations for the quality of our processes and standards.

As part of the regulatory compliance, The Harley Medical Group ensures that all of its surgeons are registered with the General Medical Council (GMC) or the Irish Medical Council (IMC) and are Specialists in Plastic Surgery, with certification which reflects this. In addition they all have extensive experience in Cosmetic Surgery.  As a nurse-led organisation, The Harley Medical Group employs nurses, who are registered with the Nursing and Midwifery Council (NMC) and are fully trained on a continuum in the application of cosmetic counseling, pre and post operative care and non surgical procedures. This ensures that we meet both the expectation of our patients and those of the regulatory bodies.

Be assured that The Harley Medical Group is doing everything in its power to support its patients.