EU Falls Into Regulatory Knee-Jerk Trap In Response To PIP Scandal

In short

The European Parliament has issued a resolution which, like it or not, will have a bearing on the medtech industry and may not prevent the problems it was tasked to address.

A breast implant register, more stringent checks and product traceability, and a pre-market authorisation system are among the measures proposed by the European Parliament’s Environment and Public Health Committee on Wednesday to prevent a recurrence of the PIP defective breast implants case. The resolution was passed unanimously in what looks like a slightly clumsy attempt to look like the reigns are now being held very firmly. But are MEPs the best qualified bunch to be holding them?

Transposing EU legislation into national laws “has not avoided this health fraud, which has led and will lead to an international serious negative impact on public health”, says the resolution as it seeks to reprimand every potentially half-connected party and fails to distinguish between deliberate fraudulent activity and regulatory control.

Background

According to the EU committee’s release, an estimated 400,000 implants made by the French manufacturer Poly Implant Prothèse (PIP) have been sold worldwide. These implants were widely used in the UK, France, Spain and Germany. However, the number of women who have received them is unknown.

Picking up (and not being able to resist commenting on) a few highlights from the committee’s musings then;

The PIP case “has shown a malfunctioning at European and national levels, notably a lack of cooperation and a lack of traceability of raw material used for medical devices”.

Show me the regulatory system that can “fraud proof” that and I’ll be convinced. This is the first recorded incidence of deliberate deception in order to save a few quid, so let’s build a new and burdensome degree of restriction around it shall we?

“The case of PIP implants, as well as the case of hip implants have shown a failure of the current system of certification of compliance, as well as of the controls of the notified bodies and their surveillance by national competent authorities”

Not true at all in the hip case. In an attempt to design a hip for younger patients the developers of these devices fell foul of a problem that was unanticipated and again would have been hard to pick up without incredibly burdensome restriction. Even FDA didn’t spot it early enough and it was the MHRA who eventually showed us all the power of data.

“It is essential to learn from this fraud and to strengthen surveillance and safety controls and placing on the market requirements for medical devices, including breast implants”

Agreed wholeheartedly, but let’s not swing too far to the opposite extreme. Clinical study requirements are all well and good, but far weaker than excellent post-marketing surveillance as a means of assessing product performance in th ereal world.

EU legislation in this area is to be revised this year. Market surveillance, vigilance and the functioning of notified bodies must be improved, “so as to avoid a repetition of the PIP case” 

You don’t say.

There is also a need for “increased traceability of implanted medical devices”, and for “increased coordination between Member States when it comes to reporting and warning about serious side effects or damage done” by these devices.

Agreed.

Furthermore, patients’ associations, patient groups and health care professionals must be encouraged to report all adverse events and harmful effects of these devices without being hampered by a great deal of red tape.

Cautiously agreed, although quite what red tape exists at the moment which is so hampering is not clear.

The European Commission is asked to shift to a pre-market authorisation system for certain medical devices and patients must be made aware of breast implant risks.

FDA PMA here we come! Another clumsy attempt to appeal to Joe Public who may actually be better served by getting technology quicker than not getting it at all. And where’s the breast implant focus coming from all over again? One fraud-based disaster shouldn’t cause the remaining products out there to be singled out for special treatment. Why not pacing wires or shrinking stents or pedicle screws or carbon fibre ligaments or pretty much any device subject to any alert over the past twenty five years?

MEPs call for the introduction of an implant recipient’s passport, stating the implant’s specific characteristics and its potential adverse effects, and a breast implant register in each Member State.

Fair enough. Increased bureaucracy is probably inevitable, but we need to limit it to areas where it will have an impact.

These registers should be interconnected and allow for the exchange of information when needed, for example in cases where important defects are detected in implants.

So who’s in charge of this then?

Finally, a system of collective redress should be put in place to help patients to obtain compensation.

From whom? PIP doesn’t look like it’s in much shape to cough up.

MEPs advocate stepping up checks, inspections, market surveillance and information sharing on adverse effects so as to ensure improve medical device traceability and follow-up.

Agreed. As we’ve said all along the answer lies in empowering the cops better and also by smarter post-market surveillance measures with firmer implementation than “no problems this year? Ok great”.

The criteria for accreditation and assessment of notified bodies and transparency with regard to their functioning and tasks should be strengthened and a European qualification management system should be established for notified bodies.

Yep, agreed again.

A single European data base should be established to bring together information about medical devices on the market, registration of economic operations, vigilance and market surveillance; clinical investigations, notified bodies and EC certificates issued.

Yep, that’s been a yawning gap for a long long time. Any time lag or lack of communication when one agency issues an alert and other competent authorities do likewise is neither justifiable nor acceptable. If a product had a central record including its regulatory and most specifically alert status that would be a superb resource.

 

So does Eucomed agree too?

Now, having written all that, we see European medtech industry body leaping politely into the fray and seeming to be on the same page as us, albeit from the stance that it doesn’t want to upset anyone. We, on the other hand, really don’t have quite such a vested interest in being so politically sensitive.

Eucomed doesn’t like the European PMA idea any more than we do and its press release, which can be found here by the way, challenges the assertion that the metal-on-metal hip debacle was a problem of European regulatory weakness as being “not fact-based”, which indeed it isn’t. FDA did not pick it up, UK MHRA did (Did we already say that earlier?)

One slight problem in Eucomed’s argument is that all-metal hips only went through 510(k) approval and may have been picked up if subjected to a PMA, but nevertheless the point is well made that even the rigorous US regulations missed it.

So there we have it. A bunch of politicians has oversimplified somewhat the complex world of medtech regulation in what they no doubt consider is a politically astute appeal to a populus indignant about dodgy breast implants. In so doing they may have just set a hare running and ultimately may be responsible for burdening the medical device industry with a fairly bleak and overregulated future… or they may have saved us all from the evil miscreants that characterise the medical device industry.

Source: European Parliament’s Environment and Public Health Committee, Eucomed, medlatest staff