HC 163 Regulation of medical implants

Written evidence submitted by The Harley Medical Group (MI 16)

The PIP crisis has affected our company significantly in the past two years: we are probably the largest single user of PIP implants in the UK, having used them in nearly 14,000 operations.

We feel that PIP patients have been totally let down by the European regulatory system, of which the various local health agencies are part, such as the MHRA, the Irish Medicines Board and the French AFSSAPS, just to name a few. We also feel that all the users of PIP implants, whether they be individual surgeons, national health services or private providers such as our group have been equally let down. I have laid out below what we feel are the main issues with the situation, and by implication, what we would recommend going forward.  Please note that our recommendations are based on our experience with breast prostheses. We do not use other types of medical devices.

1.      Testing before commercialisation starts

Before the PIP crisis broke out, we took the CE mark as a guarantee of safety. We knew that the CE mark was not an indication of efficacy, contrary to the FDA approval, but we assumed that CE-marked implants had been tested thoroughly and found to be safe. Of course when the crisis broke out we researched these matters to find, to our surprise, that the CE marking was an "after the event" mechanism, with testing and auditing by European agencies taking place after the product had been commercialised. We feel that the testing process by the regulator should take place before commercialisation, in the same way has happens with the FDA process.

2.      Testing after commercialisation starts

The testing that currently takes place after commercialisation is not adequate and we recommend as follows:

· The visits to the manufacturer must be unannounced and must take place several times a year;

· There must also be visits to the distributors of the devices in each country. For instance, we feel that the MHRA should have inspected PIP’s UK distributors (Cloverleaf) annually on an unannounced basis, with sampling and testing of the stock and publication of the results (in the same manner as the Care Quality Commission inspects healthcare establishments and publishes the results of the inspections, for the public to see).

3.      Gathering of adverse incident information

The PIP crisis has brought to light the inadequacy of the information gathering system for adverse incidents in the UK. Clearly this has been made worse by the disbanding of the Breast Implants Register in 2006. We recommend the following going forward:

· A compulsory breast implant register managed by the MHRA. Whenever implants are inserted, implanting centres would send data to the register, enabling the identification of the implanting centre, the implants and the patient.

· A compulsory reporting mechanism to the MHRA whenever there is a post-operative complication with a patient fitted with the implants. Again the implanting centres would generate this data, which would enable the identification of the implanting centre where the revision surgery takes place, the patient and the implant.

4.      Accountability of regulatory authorities

We feel that there is a lack of accountability of the MHRA or the European regulatory authorities.

The PIP crisis is clearly the result of the failure of regulations of medical devices in Europe. As an organisation our first reaction when the PIP crisis broke out was to turn to these organisations for redress and help, on the basis that they are responsible for the safety of medical devices in Europe through the CE-marking. Much to our surprise and disappointment, they did not admit any responsibility or liability in relation to the situation. Worse, they put the onus on organisations such as ours and on individual surgeons to provide remedial surgery to PIP patients at no cost.

As things stand, many PIP patients who want their implants removed and / or replaced have to fund the revision surgery themselves, as providers such as THMG or individual surgeons cannot afford to offer free revision surgery to tens of thousands of patients. Their only route is litigation and there are currently many cases building up. This is not desirable for all parties involved, but for patients in the first place.

We feel that regulatory authorities should be made properly accountable for their failures (see insurance system below).

5.      Insurance system

A similar crisis took place in the late 1990’s with Trilucent breast implants. The manufacturers were suitably insured and organised, through BUPA and the UK private healthcare sector, for all Trilucent patients to be treated. All removals took place over a two year period in a managed and orderly manner and as a result litigation was minimal.

In the current situation, the manufacturers have disappeared and their insurance policy cannot be relied upon as fraud was committed. Going forward, we recommend that regulatory authorities should take insurance to be able to step in financially in such circumstances and fund the resolution and the management of such crises. The cost of that insurance should be passed on to the manufacturers. Overall this would increase to cost of medical devices but it would also ensure that the authorities can step in fast to address the anxieties of patients and providers and minimise litigation.

6.      Transparency of regulatory authorities in their communications

We feel that the communications of regulatory authorities are, in some cases, a misrepresentation of the truth. For instance, the MHRA’s website currently contains the following statements:

· "The MHRA’s mission is to enhance and safeguard the health of the public by ensuring that medicines and medical devices work, and are acceptably safe."

· "The MHRA is fully accountable to both the government and the public".

Sadly, we have experienced at first hand the inaccuracy of both statements and we feel that until a proper testing and auditing system (see 1, 2 and 3 above) and an insurance mechanism (5. above) are in place, health authorities should tone down their claims and be absolutely transparent to the public about the shortcomings of the current regulatory system and the limitations of the recourses available to patients and providers in situations of crises such as the current one.

We hope that this crisis will give rise to an honest and thorough overhaul of the regulatory system in the UK. Please note that similar recommendations were already made in 2001 in the wake of the Trilucent crisis (see submission to the House of Commons Select Committee on Health by Paul Balen of Freethcartwright Solicitors, March 2001). Unfortunately, they were not followed. Let us not make the same mistake this time.

April 2012