Lawford Kidd's Blog

The Scottish Parliament has published details of new measures that are designed to improve the safety and rights of patients.

These provisions are contained in a new Health Bill, which includes measures to create a statutory Duty of Candour that would apply to all health and social care organisations.

This would place a duty on organisations to be open when a patient has suffered unintended harm during a period of treatment or care. The Bill also provides for support for all involved, and training for any staff involved in responding to an incident.

Patients undergoing operations in private hospitals may be put at risk from inadequate equipment, lack of intensive care beds, unsafe staffing arrangements, and poor medical record-keeping, according to a new report from the Centre for Health and the Public Interest (CHPI).

The report reveals that over 800 people have died unexpectedly in private hospitals in England during the last four years. Unlike in the NHS, private hospitals are not required to make data on hospital deaths publicly available, which can make it difficult for the public to understand how safe these hospitals are.

The CHPI report is the first to bring together what is known about patient safety in private hospitals in England. It found that:

The NHS Medical Director’s expert group, which has been looking at PiP breast implants, has published its final report.

The findings of the group include:

• Exhaustive world-wide testing of the PiP gel material has not revealed anything which could cause a long-term threat to human health – they are not toxic nor carcinogenic.
• They do, however, have a higher rupture rate – around two times higher. The rate of rupture appears to be around six to 12% after five years, rising to 15 to 30% after 10 years (this compares to 10-14% after 10 years for other brands of implants).
• PiP implants have a higher concentration of certain compounds called siloxanes – chemically similar to silicone but of a lower molecular weight and found in many consumer products, including hair and skin care products, antiperspirants and deodorants – but this does not present a health risk.
• Although the contents are not harmful and the gel has not been shown to contain any toxic substances, the inferior mechanical strength of the implants led the group to consider this a substandard product.

The expert group has said that the advice to women who have PiP implants remains unchanged. It is expected that all providers of PIP implants will contact their patients. If women are unsure of the make of their implant they should contact their surgeon or provider.

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.

These changes would ensure that the adverse effects of medicinal products will be better monitored, to prevent the recurrence of cases like the French diabetes medicine "Médiator" (benfluorex), which led to many deaths.

"Médiator" (benfluorex) was authorised to treat diabetes but was widely prescribed as an appetite suppressant. It was on the market for over thirty years, and caused between 500 and 2,000 deaths, showing the limits of the early EU pharmacovigilance system.

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.