OFFLINE

We are doing our utmost to answer your questions and let you access a surgeon when you need it. We do apologise if we are unable to talk to you, our phone lines are exceptionally busy and we are doing our best to answer all your calls, alternatively, please email your details as detailed below to PIPpatientIDdata@harleymedical.com Thank you for your patience and understanding.

8 January 2012

The advice from the Department of Health continues to be that there is not sufficient evidence to recommend routine implant removal and women who are concerned should speak to their GP. The Department of Health’s expert review has not established if the rupture rate is higher for PIP implants than for other implants. It has also confirmed that there is no evidence of any cancer risk from the materials used.

PIP implants were licensed in the UK by the MHRA, an agency of the Department of Health, for use in the UK. As a result, the NHS, private clinics, private hospitals and private surgeons used these implants in cosmetic and reconstructive surgery.

Today, some media have quoted inaccurate numbers of operations carried out by our Group involving PIP implants. We have been auditing our rupture records for many years now and have not found, to date, cause for concern. As a large user of PIP implants in the UK, we communicated this data to the MHRA in order to help them put things in the right context. The data we submitted to the MHRA is as follows:

In total, we conducted 13,900 operations with PIP implants in the UK between September 2001 and March 2010.

We started collecting rupture data from September 2004.

Between September 2004 and March 2010, we conducted 11,837 operations with PIP implants in the UK.
Of these 11,837 operations, we had recorded 213 ruptures at 30 November 2011, resulting in an aggregate rupture rate of 1.8%.

Of these 11,837 operations 6,010 are four years old or more.

Of these 6,010 operations, we recorded 79 ruptures four years post implantation, resulting in a rupture rate four years post implantation of 1.3%. This is well within available measurements.

What you should do
If you have already contacted us, please bear with us as we are doing our best to contact you as soon as we can.

If you experience symptoms such as pain, heat around the breast area, redness, inflammation or rippling, please call us on 0800 022 3387 (UK) / 1850 211 547 (Ireland) .

Due to the a large number of enquries we will not be able to answer individual questions. For the most up-to-date information please revisit the website.

If you are unable to contact us on this number, please email us on PIPpatientIDdata@harleymedical.com and we will get back to you as soon as possible. Please note that in order to help us locate your records, you must give us the following information:

- Full name *

- Date of birth *

- Your surname at time of your operation *

- Your address at the time of your operation *

- Current address

- Current contact telephone number *

- Originating clinic *

* denotes a compulsory field

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. The MHRA is an agency of the Department of Health and the only competent authority in the UK for medical devices such as breast implants. 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.

IHAS responds to Government advice on PIP Implants

"The IHAS applauds the Department of Health’s decision not to cause women unnecessary worry and trauma by advising immediate explantation of PIP implants.  We welcome the clarification of advice today but we now want the Government to face up to their responsibility as regulators of PIP implants.  All public and private sector surgeons used these implants, which were not the cheapest on the market, in good faith with the knowledge that they had been approved by the Department of Health agency, the MHRA.

“Our current advice to patients is to visit the website of their clinic provider and follow the advice detailed there.  Patients can be assured that all of our member organisations are prioritising patient care above all else and all have all undertaken to provide free consultations for women who would like to consult a surgeon.”

The Department of Health says that their main concern is the safety of and compassion for women who have had PIP implants and are seeking to offer them as much advice and evidence as is available. The government’s expert review has not been able to establish if the rupture rate is higher for PIP implants than for others.  It has also confirmed that there is no evidence of cancer risk from the materials used.  Therefore their advice remains the same: that there is not sufficient evidence to recommend routine removal and women who are concerned should speak to their GP or surgeon.

“Well before this issue emerged we were encouraging the MHRA development of a national, compulsory, device-based Register, following the dissolution of the breast register in 2006 and we continue to champion this course of action."  

Source: Sally Taber, Director of The Independent Healthcare Advisory Services dated 6 January 2012