Over the last few days new information has come to light following the previous statement provided by the Medicines and Healthcare products Regulatory Agency (MHRA) in relation to the French manufactured PIP Implants.
The MHRA first concluded that the implants had a 1% rupture rate which conflicted with the French Authorities’ figures of 5%. BBC News reported that the Transform cosmetic surgery group has since come forward with a higher rupture rate. The BBC News reported that Transform have reported that seven out of 108 patients fitted with the implants have suffered ruptures. This has prompted the Health Secretary, Andrew Lansley, to request a review into the safety of the implants.
Both the French and British Authorities maintain that the implants are not linked to cancer and the UK review, led by the NHS Medical Director, Professor Bruce Keogh, is to investigate the rupture rates of the implants.
BBC news has reported that the French Government has since recommended that women with the PIP Implants should have the option of having the implants removed as a preventative measure. The French Authorities have stated that they will cover the cost of removal of implants for all patients but they will not cover the cost of replacement implants unless the patient had the implants inserted as part of reconstructive surgery following a mastectomy for breast cancer. The French Government also advised that women who decide not to have their implants removed should have free six-monthly ultrasound scans.
The British Association of Plastic Reconstructive and Aesthetic Surgery (BAPRAS) have issued a media statement reiterating its recommendation that “PIP breast implants should be gradually removed in order to best protect the women involved”. Mr Goodacre, consultant plastic surgeon, of BAPRAS, advised that “while the evidence shows that there is no need for panic as there are no proven links with cancer, the probable increased risk of rupture and potential irritation of the sub-standard silicone gel used in these implants means it would be sensible for the implants to be removed whilst they are still intact.”
The British Association of Aesthetic Plastic Surgeons (BAAPS) has also agreed that the approach being taken in France is “not unreasonable”.
In the light of the uncertainty about the rupture rate BAPRAS has called for a national register of all breast implant operations whether under the NHS or in the private sector.
BAPRAS has reported that the MHRA has scheduled “an expert meeting on behalf of the Department of Health”.
Amey Welch, Legal Assistant, Clinical Negligence
The British Association of Plastic Reconstructive and Aesthetic Surgery
http://www.bapras.org.uk/news.asp?id=947
The British Association of Aesthetic Plastic Surgeons
BBC News
http://www.bbc.co.uk/news/health-16373140
