Tighten safety on medical implants

medical implants, plastic surgery, pip

EU regulations on the safety of medical implants must be urgently tightened in response to evidence that manufacturers are seeking approval for devices in Member States with the least stringent regulatory regimes, MPs have warned in a report out today.

Chair Andrew Miller MP, said:

"Thousands of patients use medical implants in the UK every day without problem. When things do go wrong with implants however, it can ruin lives -as the complications with metal-on-metal hip replacements have sadly shown.

We were shocked to hear about the practice of so-called 'forum shopping', where manufacturers shop around for the least stringent regulatory regimes in which to get their medical implants approved.

Much greater transparency is needed about the approval process so patients and doctors can have full confidence in the implants they are using."

Clinical data

Recent recalls of metal-on-metal hip replacements and other faulty medical implants show that manufacturers and regulators must also publish more rigorous clinical data on the safety of new implants and be subject to greater scrutiny, according to the Science and Technology Committee.

The clinical data requirements for high-risk medical devices to be sold on the European Market are much less stringent than for new medicines. The MPs were unimpressed with the extent to which reliance on equivalence - similarity to an existing implant - rather than clinical investigations of the implant being approved, seemed acceptable in pre-market assessment.

Public record

The Committee calls for all clinical data used in the approval of a medical implant to be published without identifying patients or clinical trial participants. For products currently on the market, such data should be published immediately. There should also be a public record of every approach from a manufacturer to any notified body in the EU so that ‘forum shopping’ can be identified.

UK regulatory body the Medicines and Healthcare products Regulatory Agency (MHRA) is criticised in the report for its slow reaction to reports of problems with metal-on-metal hip replacements in Australia. Because of that delay, many patients have suffered needlessly.

Andrew Miller MP, added:

"The Minister's view that the MHRA’s response to the problems with metal-on-metal hip implants was a "good news story" shows some complacency in not recognising failings in the system.

The EU and UK must improve the speed with which information from adverse incident reporting abroad is handled and acted upon.

The NHS needs to develop better systems for dealing with reports of problems with medical implants. It could learn from best practice in the private sector, so that it can recall faulty products as rapidly as aviation companies do when problems emerge."

PIP breast implants

The withdrawal of PIP breast implants - after it was discovered they had been filled with unapproved silicone - also highlights the need for frequent and unannounced spot-checks of medical implant manufacturers to identify and prevent similar problems. The Science and Technology Committee is strongly supportive of proposals to enforce unannounced audits of manufacturers and recommends that audits should take place at least annually.

Currently, all the parties involved in applying the Medical Devices Directive are bound to observe confidentiality with regard to all information obtained in carrying out their tasks. The Committee is largely supportive of the proposed legislative changes from the European Commission to improve transparency and scrutiny surrounding the regulation of medical implants.

Background

In August 2010, two metal-on-metal hip implants manufactured by DePuy were recalled worldwide because data from the National Joint Registry (NJR) of England and Wales showed that a large number of people had experienced problems and required a second hip replacement surgery.