Accident Claims & Personal Injury Lawyers Scotland Blog

Proposed new changes to existing EU legislation, backed by the European Parliament's Public Health Committee, would trigger an automatic EU safety evaluation in the event of a safety alert about a medicinal product in any EU Member State.

New evidence has emerged which shows that around 7,000 more women in the UK may be victims of the PiP scandal caused by a French breast implant manufacturer, Health Secretary Andrew Lansley has announced. These women will be eligible for the same NHS care as announced in January.

French authorities had previously advised that only PiP breast implants that were used after 2001 may have been made with unauthorised silicone gel. Following an investigation by the UK regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), the French authorities have now reported that PiP implants made before 2001 may also contain unauthorised silicone gel.

This means an extra 7,000 women, who had PiP implants before 2001, could be affected. About one in five breast implants need replacing within ten years, whatever the make, so it is unlikely that all these 7,000 women still have the same PiP implants.

The independent expert group – led by the NHS Medical Director Professor Sir Bruce Keogh – continues to advise that there is not enough evidence to recommend routine removal of PiP breast implants given that this would mean many women having to have surgery.

However, the government has recommended that if women are concerned they should speak to their surgeon or GP. The NHS will support removal of PIP implants if, after this consultation, the patient still has concerns and with her doctor she decides that it is right to do so. The NHS will replace the implants if the original operation was done by the NHS.

The government expect the private sector to do the same for their patients. It believe that private providers have a duty to take steps to provide appropriate after-care to patients they have treated. If a clinic that implanted PiP implants no longer exists or refuses to care for their patient – where that patient is entitled to NHS services, the NHS will support the removal of PiP implants where clinically necessary.

European Health and Consumer Policy Commissioner John Dalli has called on Member States for immediate action to be taken at national level to ensure full and stringent implementation of the current legislation on medical devices.

Following the discovery of the use of non medical grade silicone in breast implants manufactured by the Poly Implant Prothèse (PIP) Company in France, the priority now is for the Member States and the Commission to act together to tighten controls, provide a better guarantee of the safety of medical devices and to restore patient confidence in the law that protects them.

Commissioner Dalli has written to Member States asking for their co-operation within the existing legal framework to tighten controls, in order to provide a better guarantee of the safety of medical technology, especially high risk devices. The actions proposed include the following:

Lanarkshire Health Board has been fined £24,000 at Hamilton Sheriff Court for a breach of Section 3 of the Health and Safety at Work etc Act 1974, which led to the serious illness of a hospital patient.

Over the course of November 2008, the 64-year old female patient at Hartwoodhill Hospital became gravely unwell.

She was admitted to Wishaw General Hospital, where it was discovered that she was suffering from pneumonia and severe sepsis and was diagnosed as having Legionnaires’ Disease. She was treated with intravenous antibiotics, but required to undergo a tracheotomy on 1st December 2008. She returned to Hartwoodhill Hospital on 23rd December.

An investigation by the Health and Safety Executive (HSE) identified that legionella bacteria was present in three sources in the water system at the hospital. Two of those sources, including the shower used by the patient on a daily basis, matched the strain of legionella bacteria that had caused her illness.

The HSE investigation also established that a suitable and sufficient assessment of the risks from the potential presence of legionella bacteria to persons using the facilities had not been carried out, nor was there a safe scheme in place to manage and control the risks of exposure to that form of bacteria in the water system at Hartwoodhill Hospital.

Following the case, Elaine Taylor, Head of the COPFS Health and Safety Division, said: “Legionnaires’ disease is a very dangerous illness and those who fail to manage their systems adequately and expose persons to risk of contracting it, whether private companies or bodies such as Health Boards, can expect to be prosecuted.”

The Department of Health has published the terms of reference for two reviews established following the recent concerns about PIP implants.

The first review, led by Lord Howe, the Minister for Quality, will establish what happened in the UK when the MHRA and Department of Health learnt about the situation with PiP implants in France. Lord Howe will submit a report to the Health Secretary by the end of March.

The second review will be led by Professor Sir Bruce Keogh, the NHS Medical Director, and will look at whether the cosmetic surgery industry needs to be more effectively regulated. This review will take around a year to complete given the complexities of the issues. He will aim to give a report to the Health Secretary by March 2013.

In particular, it will look at: