Harley Medical Group Statement: 8 January 2012

Dear patientsWe are doing our upmost 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 and concerns as detailed below to questions@harleymedical.com. Thank you for your patience and understanding.  8 January 2012The 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 measurments.

What you should do

If you have already contacted us in last few days, 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) . If you are unable to contact us on this number, please email us on questions@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 * - Your surname at time of your operation * - Current contact telephone number * - Current address- Date of birth * - Date of operation - Your address at the time of your operation * - Originating clinic * - Originating surgeon * - Hospital where you had your operation* 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.