Lawford Kidd's Blog

Lawford Kidd's injury solicitors' blog designed to cover all areas of the law relating to accident compensation claims, injury claims and no win no fee in Scotland.

Update on PiP breast implants

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.

 

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Scope of cosmetic surgery reviews

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:

  • whether the regulation of the products used in cosmetic interventions is appropriate;
  • how best to assure patients and consumers that the people who carry out procedures have the skills to do so;
  • how to ensure that the organisations which deliver such procedures have the clinical governance systems to assure the care and welfare of people who use their services;
  • how to ensure that people considering such interventions are given the information, advice and time for reflection to make an informed choice;
  • whether there should be a statutory requirement for such organisations to offer redress in the event of harm, and if so how this could be funded;
  • what improvements are needed in systems for reporting patient outcomes, including adverse events, for central analysis and surveillance.


The review will consider issues of governance, data quality, record keeping and surveillance, as well as ensuring that sufficient information is provided to secure patients’ informed consent. It will include consideration of the feasibility of an outcomes-based register of commonly implanted devices.

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