Monday, 14 May 2012

PIP breast implants: 'serious lessons must be learned'

The implants were manufactured by the French company Poly Implant Prothese (PIP)
A government review into the PIP breast implant scandal has found that serious lessons must be learned.
The review was led by the Health Minister Lord Howe and examined the role of the Department of Health and the UK regulator the MHRA.
It says that although the MHRA followed scientific and clinical advice, it should "review and further develop its communications capability."
It must "obtain evidence from a wider and more detailed set of sources..."

The report says this was a case of deliberate fraud by the PIP manufacturer and regulation alone cannot prevent that. "But serious lessons must be learned from this scandal. The MHRA needs to look at how it gathers evidence so it is able to identify problems early. It needs to better analyse reports about higher risk medical devices. And it needs to improve the way it communicates with the public. "
The report also found that the regulators in all EU countries need to work better together to support early detection of problems, share the information they gather and take appropriate action to protect patients.
cosmetic surgery
Around 47,000 women in the UK have PIP breast implants. Around 95% of all PIP implants were fitted privately. A minority of operations were carried out on the NHS, mostly for breast reconstruction following cancer.
Lord Howe's review into PIP implants is one of two set up by the Department of Health in January.
The second review, led by Professor Sir Bruce Keogh, the NHS Medical Director, will look at whether the cosmetic surgery industry needs to be more effectively regulated.
In January Prof Keogh's team concluded there was insufficient evidence to recommend the routine removal of PIP implants. But it recognised the concern that the issue was causing.
Throughout the UK any women who had PIP implants fitted on the NHS can get them removed and replaced free of charge.
In Wales the NHS will also replace those of private patients. In England and Scotland the NHS will remove implants of private patients but not replace them.
Latest figures from the Department of Health in England show that 6,632 women with private PIP implants have been referred for hospital checks; 3,865 scans have been completed.
185 women have had their implants removed. 836 NHS patients with PIP implants have been contacted, 82 scans completes, and 66 women have had the implants removed.

Originally posted HERE