Harley Medical Group Statement: 8 January 2012
08 January 2012Dear 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 [email protected] 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 Healthís 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.