Justice CommitteeWritten evidence submitted by Jane Edwards

With reference to the Inquiry into the Regulation of Medical Implants, I wish to make the following points in answer to the questions to be raised.

1. Are current legislation and regulations on safety and efficacy of medical implants fit for purpose?

Current legislation is not fit for purpose, hence the vast numbers of cases which require revision surgery and compensation claims should be urgently addressed.

2. How effectively does the MHRA implement the Directive in the UK?

Evidently not very effectively since it appears they gather the information but cannot act upon it.

3. How could the legislation and regulations be improved?

More comprehensive trials to force manufacturers to be more open and honest (stop hiding behind takeovers, stop rushing new items through before thorough testing or taking the cheapest component option) and ensuring patients are given all the necessary tests (ie blood and allergy tests) before the type of implant is considered.

4. How could the European Commission ensure that potential changes to the Medical Devices Directive do not hinder the introduction of innovations in medical implants to the market?

By using less biased assessment of engineering results (assessment by other than the manufacturer of the implants). Greater impartial (non-manufacturer) engineering involvement in final development stages.

I trust the Select Committee will ensure that the above points are taken into consideration.

April 2012

Prepared 30th October 2012