Lawford Kidd's Blog

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.

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:

• Verify the designations of notified bodies to ensure that they are designated only for the assessment of medical devices and technologies that correspond to their proven expertise and competence.
• Ensure that all notified bodies in the context of the conformity assessment make full use of their powers given to them under the current legislation which including the powers to conduct unannounced inspections.
• Reinforce market surveillance by national authorities, in particular spot checks in respect of certain types of devices.
• Improve the functioning of the vigilance system for medical devices for example by giving systematic access for notified bodies to reports of adverse events; encouraging healthcare professionals and empowering patients to report adverse events; enhanced coordination in analysing reported incidents in order to pool expertise and speed up necessary corrective actions.
• Support the development of tools ensuring the traceability of medical devices as well as their long-term monitoring in terms of safety and performance, such as Unique Device Identification systems and implant registers.

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.”