Verbatim report of proceedings

Wednesday, 13 June 2012 - Strasbourg

19. Defective silicone gel breast implants made by French company PIP (debate)

  President. – The next item is the debate on the oral question to the Commission on the defective silicone gel breast implants produced by the French company PIP, raised by Philippe Juvin and Thomas Ulmer, on behalf of the Group of the European People’s Party (Christian Democrats), Linda McAvan and Gilles Pargneaux, on behalf of the Group of the Progressive Alliance of Socialists and Democrats in the European Parliament, Corinne Lepage and Antonyia Parvanova, on behalf of the Group of the Alliance of Liberals and Democrats for Europe, Margrete Auken and Michèle Rivasi, on behalf of the Group of the Greens/European Free Alliance, Marina Yannakoudakis, on behalf of the European Conservatives and Reformists Group, Marisa Matias, on behalf of the Confederal Group of the European United Left – Nordic Green Left, and Oreste Rossi, on behalf of the Europe of Freedom and Democracy Group (O-000101/2012 – B7-0118/2012).

  Sophie Auconie, author. – (FR) Madam President, Commissioner, ladies and gentlemen, it is clear that the PIP implants affair is not a simple case of national sanitary fraud. Unfortunately, we can see to what extent it is having, and will have, an impact at European and international level.

Allow me to give you some figures to illustrate the point. PIP implants were marketed in 71 countries worldwide. Some 400 000 breast implants were sold, affecting approximately 40 000 women in the United Kingdom, 30 000 in France and 10 000 in Spain. The Medical Devices Directive will be revised this autumn. We, as legislator, must learn from this fraud and strengthen our market surveillance and vigilance system for medical devices.

I lend my support to the proposals made by Thomas Ulmer and Philippe Juvin, the rapporteurs of the resolution on behalf of the Group of the European People’s Party (Christian Democrats), who apologise for being unable to be here this evening. I call on the Commission to take the following recommendations into consideration. We must strengthen and harmonise inspection obligations at Community level. Regular, unannounced, annual inspections need to be carried out urgently at all stages in the life of a medical device. The conditions of accreditation of notified bodies must be harmonised and the traceability, transparency and monitoring of medical devices placed on the European market must be strengthened.

Finally, I wish to draw your attention to a fundamental point: the need to find a balance between protecting our European patients and supporting innovation and research. We must bring together safety, transparency, consistency and flexibility. The first consistent approach is not to treat medical devices like medicinal products. There are three fundamental differences: a difference in nature, a difference in time to market, and a difference in terms of market flows.

Consequently, it is clear that the introduction of a market authorisation for the highest-risk medical devices would only result in administrative burdens, additional costs, longer times to market and, above all, it would stifle innovation. That is something that needs to be assessed depending on the case.

  Linda McAvan, author. – Madam President, I agree with nearly everything that is in the resolution before us this evening. I am looking forward to hearing Commissioner Dalli tell us how the revision of the Medical Devices Directive will take on board the lessons we can learn from the PIP scandal which, as Ms Auconie has said, has affected so many women in the European Union and beyond.

But I want to talk tonight about something a little wider than our resolution. It is about my amendment on advertising. We do not allow prescription medicines to be advertised in the European Union, yet we do allow magazines – women’s magazines mainly – to publish adverts like this: pages and pages of glossy, full colour adverts urging women to get breast implants. Two countries have already banned this kind of advertising – France and Belgium – but in the rest of Europe, this is pretty normal stuff. I wonder, Commissioner, whether you could tell us if anything can be done about it at European level.

If you look at the websites of these same companies, they have these frequently asked questions about breast surgery on them. It tells you how much you will pay, and how to get a loan to have the surgery. It does give you some facts about the surgery, but nowhere does it say that 30% of women will have to have a new implant within 10 years, and that nearly all implants have to be replaced at least every 10 to 15 years. In other words, if you go at the age of 32, which is the average age for having a breast implant, for the rest of your life, you will have to have another implant and then another implant, and so on. I looked at three reputable companies. Not one website mentioned this fact – not one. I do not think that is good enough.

When people have major surgery it is a risk to their health and I do not think there is enough information out there. We need informed patients. Commissioner, I do not know what your competence is, but as we have laws on advertising prescription medicines, I consider it about time we regulated this industry, which is encouraging people to take risks. Many women who have been surveyed were not aware that this meant repeat operation after repeat operation.

(Applause)

  Margrete Auken, author. – (DA) Madam President, in this situation, I think it important that we manage to point out that product approval needs to be much, much better in future than it has been hitherto. That is something that we are all well aware of. I would very much like to emphasise that what particularly needs to be the case from now on is that there must be transparency, there must be openness, there must be access so that independent researchers and doctors, too, can come in and check trial data. In other words, it must be impossible, where there are human trials, for the industry to cover up the results. It must be possible, at any point in the process, to come in and evaluate the following questions. Have there been any harmful side effects? Is this actually an improvement? Is there, in fact, no improvement? Are we ripping off society by producing new devices where the old ones actually worked perfectly well already?

I believe that it is absolutely crucial that we should have that transparency and I very much hope that Commissioner Dalli will support the idea of it now being the patient, the people, the citizens, who are put at the heart of things, rather than the industry.

In addition, I hope that we can bring about a situation where, if there is deception with the results, which is something we have seen with the medical industry – and I am not, now, talking about the breast implants; what was done there was illegal, after all, but there can be a great deal of other deception – it must be treated as a crime, not just as something that can be sorted out by means of fines.

Finally, I would like to say to my fellow Members and also to the Commission that, if the industry gets a sniff of the idea that there is a prospect of there being real, actual, true transparency and access to the unprocessed data, it will bring a highly formidable lobbying arsenal to bear against us. We will have to face all kinds of accusations of how we are destroying their opportunities, reducing chances for patients, destroying competitiveness and destroying options for research and innovation. I thus very much hope that we are able to withstand the pressure we are all going to be facing, so that we can actually come up with something about which we can hold our heads up high and that we can show to the Americans (unless we are going to adopt their system) and say that what we have come up with is even better!

  Marina Yannakoudakis, author. – Madam President, six months after the PIP breast implant scandal hit the headlines, the European Parliament is finally getting round to addressing this appalling case of medical malpractice.

It is staggering to comprehend how PIP, once the world’s third largest supplier of breast implants, could disregard the law for almost ten years.

It is important we learn from public health incidents such as this. However, it is also vital that we examine all the facts before drawing conclusions on how a system might need to change to prevent such malpractice happening again.

In addition, we must stress that the PIP scandal does not illustrate a failure of the current compliance system. This was a criminal offence that involved manufacturers placing a substandard product on the market.

Although the committee resolution contains plenty of positive measures that will improve the regulatory framework for medical devices, the text also includes demands for a pre-market authorisation. This duplicates existing laws and standards and is needlessly disproportionate in my view.

Paragraph 22, for example, tabled by the Greens, calls for toxicology assessments on all medical devices. Do we really think that by nitpicking over the toxicity of everything, from elastic bandages to pacemakers, people will stop breaking the law?

Care should always be taken not to use a sledgehammer to crack a nut and I caution against knee-jerking responses that could fundamentally alter a regulatory system that has been protecting patients for more than 20 years.

My group has therefore tabled an amendment and several requests for split and separate votes, in the hope that we can iron out these inconsistencies.

  Marisa Matias, author. – (PT) Madam President, Commissioner, it is true that six months have already passed since the Poly Implant Prothèse (PIP) scandal. The most unbelievable thing is that, for 10 years, a private company could have managed to operate in the market and give women from 71 countries silicone implants that should be used for construction and manufacturing mattresses.

This affected many hundreds of thousands of women, as has already been mentioned: it is estimated at around 500 000. We are talking about estimates because there were failings, serious failings, with this process. We know that what happened with this company was criminal activity, fraud and a matter for the courts. However, we also know that this is a fraud that should be monitored by the courts and the courts will deal with it. Nevertheless, there has been a failure of the law; a legal vacuum that we should tackle. We are responsible for that area.

For 10 years, we did not manage to identify what the criminals managed to identify, so there was a vacuum in terms of monitoring, in terms of traceability, in terms of files, in terms of records; everything failed. However, the people in charge of this company managed to put into practice something that we failed to monitor, so this process does not just concern the issue of the lack of information in this regard and, in fact, all those issues relating to breast implants: those are very important, but there is also the humiliation of thousands of women and the humiliation, in particular, of those women who had to undergo tests to know whether or not they had the correct implants.

We are talking about a public health issue and we cannot be lax as regards public health: we monitor so many unnecessary things – we even monitor the authenticity of replacement car parts – and it is still not long since we adopted a directive on this. We have to monitor that which is essential to people’s lives. The revision of the Medical Devices Directive is good news, but it would be better news if we did not have to do it. However, now that we are going to do it, let us put in place transparency, monitoring and penalties with conditions and traceability because, unfortunately, even if penalties are applied, they will not benefit the women who suffered from this problem, so states should accept full liability.

  Oreste Rossi, author. – (IT) Madam President, ladies and gentlemen, the debate and the vote on the resolution come at a particularly propitious time because, if approved, the resolution can provide useful guidance for the medical device review.

The breast implants issue has highlighted the deficiencies in the current system for certifying compliance with essential health and safety requirements. In my view, the review proposals from the European Commission and Commissioner Dalli rightly seek greater controls on medical device manufacturers and greater rigour from the competent authorities when issuing authorisations. I also agree with the need to avoid creating excessive bureaucracy that might block the use of innovative products for years. I believe that it is important to ensure rigorous, efficient and swift controls at European level.

The thousands of women who have undergone breast implant surgery need to be made aware of the risks that they may face. They should be offered screening and medical advice to check for any damage and to prevent the implants from rupturing. It is important to set up a register to identify people who have been implanted with particular medical devices, so that information can be provided in good time if the devices need to be checked, altered or replaced.

Introducing an ‘ID card’ for implants would enable users to obtain information about all the potential risks to which they may be exposed and which checks are advisable over time. It is vital, within a cooperative EU framework, that Member States make specific commitments to eliminate or minimise the recurrence of such serious events as that associated with the PIP silicone implants.

  John Dalli, Member of the Commission. – Madam President, during the last 20 years, the medical device regulatory system has, overall, provided for safe, reliable and performing devices in Europe and has provided the flexibility needed for the high number of medical devices and the short life cycle of these products. It has also proven to be a system that is cost-effective and SME-friendly. It has put Europe in the forefront of innovation.

For months before the PIP case, the Commission was reviewing the Medical Devices Directive, because we found that it needed quite a number of improvements. The PIP case is indeed appalling. It is a case of fraud which went undetected due to weaknesses in the post-market phase. Nevertheless, the case has highlighted a number of weaknesses in the regulatory framework.

In order to provide a rapid answer to European patients’ concerns, I have identified, and shared with the European Parliament, a number of actions to be taken immediately, together with the Member States, on the basis of the current legislation. This includes tightening market controls, in order to provide a better guarantee of the safety of medical technology, especially high risk devices. I have therefore written to the Health Ministers of all the Member States to ask for their support, and together we are now putting these actions in place.

For the longer term, the revised medical device legislation that the Commission has been preparing – independently of the PIP case, as I said – will also take on board the experiences of this affair. The Commission intends to adopt its proposal shortly after the summer break.

A number of improvements were already foreseen to reinforce the system. These improvements will contribute to avoiding cases like the PIP implant case. To mention but a few: we want to strengthen the designation, monitoring and functioning of notified bodies and ensure that this is carried out in accordance with the same high standards across the EU; and we want a stronger role to be given to competent authorities, both in pre- and post-market phases.

The system can only be efficient if we make the best use of the limited number of experts available. This is why the Commission foresees a pre-market scrutiny mechanism to be put in place for high-risk devices, and other devices where necessary, but on a case by case basis. This mechanism will allow a committee composed of Member States’ experts to check certain notified bodies’ assessments before the devices can have access to the market.

The advantage of doing so will be twofold. First, it will ensure an equal level of assessment by notified bodies, in particular, with regard to clinical evidence. Second, it will allow Member States to be informed of products coming onto the market so that they can ensure targeted controls of these products. This mechanism has the advantage that scarce resources and expertise are used to ensure efficient and proportionate pre-market control and reinforced vigilance and market surveillance. Last but not least, we want to improve the traceability requirements for medical devices, for instance, by means of a unique device identification and a single registration system.

Following the PIP case, the Commission performed a ‘stress test’ of the medical device legislation in order to identify additional possible shortcomings of the regulatory framework and address them in the context of the upcoming revision. As a result of the stress test, additional measures will be included in the Commission proposal.

These proposals will concern the audit activities of the notified bodies. Particular attention will be paid to the obligatory unannounced visits to the manufacturer, testing of products and rotation of auditors. Information will be given to national authorities with regard to negative outcomes of such audits. Measures should also be put in place to enhance the reporting of incidents by health care professionals and patients. Patients’ awareness should also be improved through, for example, implant cards providing appropriate information.

This is where I believe that the transparency of the market should be enhanced, by giving all interested parties the right information not only – as Ms McAvan has said – about costs and benefits, but also about the duration, durability and consequences of the implants or whatever other device they are using, because this is not only a question of implants and there are other devices in use.

I believe everybody needs to know all the implications of using such devices, because some people really do think that once they go through a procedure, it is a once in a lifetime procedure, which, in many instances, is not the case. This has to be continuously put in front of our patients, or our consumers, in the way we are suggesting. These cards have to be given to every single patient who undergoes any type of procedure involving such implants. In this way, patient awareness will be greatly improved.

I do believe that the set of measures already foreseen, combined with additional measures deemed necessary in the light of the result of the stress test, will considerably reinforce the system, favour innovation and ensure that only safe and performing medical devices are placed on the European market, for the benefit of European citizens. I have taken note of the points raised by Ms Auconie and I must say that all her points are, in fact, included in the proposal that we will be presenting, as I said, just after the summer.

  Elisabetta Gardini, on behalf of the PPE Group. – (IT) Madam President, ladies and gentlemen, I thank the Commissioner for his important and very welcome comments. I agree with him that it is truly alarming that we have been living with the sheer number of cases in our various countries that Ms Auconie has reported.

Nevertheless, it is equally clear that this scandal has strongly highlighted the need for a careful reappraisal of the current European legislation on medical devices. Unfortunately, this fraud has revealed the deficiencies that we have discussed thus far in this Chamber and that the Commissioner has set out so clearly that I do not wish to dwell on this aspect in the little time I have available.

I believe that all necessary steps should be taken so that we can offer the best to our citizens. I believe that this scandal, which has taught us many things, can also be a springboard for further progress, and I echo what my colleague said earlier. Information for patients is highly inadequate. The emphasis is always, exclusively, on the upside, with allusions to a kind of eternal youth and a promise of beauty, even though no implants are completely risk-free. I believe that this should be clearly communicated to people, especially girls, for we know that some very young girls are seeking this kind of operation, and especially as regards purely cosmetic surgery. Therefore – and I see that you firmly agree – I urge that we move fast, for time is at a premium, and this change is long overdue.

  Gilles Pargneaux, on behalf of the S&D Group. – (FR) Madam President, Commissioner, we had the Mediator scandal some time ago. We now have the breast implant scandal, which, as you said, Commissioner, unfortunately highlights the shortcomings of health security in Europe.

The breast implant scandal is a case of fraud that went unpunished for 14 years, from 1996 to 2010. During that time, 500 000 implants were placed on the market, 8 000 implants were removed, 48 cases of cancer were reported, and 3 500 complaints were lodged. These are frightening, shocking figures. Commissioner, how, despite warnings from the U.S. Food and Drug Administration (FDA) and the numerous complaints and convictions for ruptured implants in Great Britain and France in particular, could national and European agencies miss such a fraud?

This tragedy immediately made us think about improving the European regulatory system for medical devices, as you explained just now. Commissioner, today we must build a system capable of preventing scandal, but it must be a new system. You told us about the new legislation to come into effect this autumn. As co-author of this resolution, I am, of course, pleased with that.

However, Commissioner, you seem to want to take into account many of our concerns, as set out in this resolution. In that case, why make an exception that is unacceptable to a large number of MEPs here in this House? Why not introduce a market authorisation for medical devices in class III, those that are highest risk? Commissioner Dalli, can you explain your position to me?

  Izaskun Bilbao Barandica, on behalf of the ALDE Group. – (ES) Madam President, I hope that the reform of EU legislation on the control of medical devices and implants is as complete as the proposals contained in this resolution.

We have learnt a lot of lessons from the PIP implant crisis, and a large number of the solutions are on the table. It is imperative that data is exchanged, warning systems are set up for EU-wide notification of any incidents, mechanical and clinical tests on the implants are improved, and transparent and improved information is available to patients.

We need a penalty system that applies to suppliers that sell dangerous merchandise and to professionals along the trade and health care chain who do not collaborate with this effort towards transparency, monitoring and control. They are ethical and scientific demands along the same lines as it being fair to arbitrate compensation for the victims of this episode.

There also things that are not easy to express aloud and to add here in a week in which financial voracity continues to swallow up our efforts to save the European project, which also contributes towards citizens’ well-being through issues such as the one being debated now. Let us remember that the alarming price difference between the products manufactured by PIP and those on offer from its competitors did not prompt enhanced control. The price, however, was the basis for PIP’s success in the implant market, and this had repercussions on the patients, the women.

I am sure that through these controls, European medical organisations will allocate the means to prevent this from ever happening again, but it is the Commission’s responsibility to urgently implement a monitoring and control system, and Parliament’s responsibility to control the content for compliance with this resolution.

For that reason, Commissioner, we hope you keep to your word.

Catch-the-eye procedure

  Mairead McGuinness (PPE). – Madam President, this is a very important debate, but while we are talking about this particular scandal, we have to recognise that the European medical devices industry has been very innovative and has helped patients a great deal.

So I welcome the balanced approach of the Commission in relation to improving our regulatory system. I am against paragraph 7 because it will overdo things and take away the possibility of the industry being innovative. What we are trying to strike here is a balance between what is good for patients and improving the quality of life of those who need medical devices.

Could I just say on a slightly different theme, picking up on the point made by Ms McAvan, that we have had a debate on female genital mutilation and we are now having a debate on breast implants. Sometimes these are used by very young girls who chose this process and who, as Ms McAvan pointed out, do not understand the consequences of it. While the debates are not linked, it is interesting that, on this occasion, we are having them both tonight.

My main point is, however, that with regard to the progress made for people who have had hip implants or knee implants, and whose quality of life has been improved by the European medical devices industry, we need to allow this to flourish and grow. We need to better regulate the notified bodies, as has been suggested, and not stifle innovation.

The separate issue of breast implants calls for another debate, about society and pressure on young women. Perhaps we can have that another time.

  Evelyn Regner (S&D). – (DE) Madam President, Commissioner, I should like to take the opportunity of this debate to mention a regulation that is currently being revised or, to be more accurate, is about to be finalised. This case of defective breast implants shows that this regulation needs further revision. I am talking about Brussels I, the regulation on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters. There are at least 60 victims of the defective breast implants in Austria who have tried in vain to bring an action via their consumer organisation in Vienna. They have not succeeded in doing so because of a gap in the regulation on jurisdiction.

We could improve the situation of these victims and many others if consumer organisations representing the victims were also able to utilise the more favourable consumer jurisdiction. The case of the defective breast implants again shows that the exclusive jurisdictions, such as the consumer jurisdiction, also need to be revised.

  María Irigoyen Pérez (S&D). – (ES) Madam President, we are debating a scandal, a scandal due to the use of PIP implants, which contained industrial silicon.

We are talking about risks, the risks run by the users: patients, many young women who go there without knowing what the implants are like, without any information at all. There are many, many legal loopholes and therefore we need to go further. As well as control, monitoring and protection, of course, more information is needed. The scandal surrounding these implants, which affects over 30 000 European women, teaches us that the suppliers that introduce these unhealthy products need to be punished. Commissioner, the patients that use these implants have a right to be informed, and not run any risks, given that nowadays, people who have implants use them not only for health reasons but also for personal improvement.

  Marc Tarabella (S&D). – (FR) Madam President, Commissioner, one might question the apparent inertia of the public authorities in this matter. In such a scenario, the victims have the right to expect real accountability and to be offered real solutions.

It is true that the actions of the monitoring committee set up by the health authorities are far from being beyond reproach.

I also note that the issue of fee surcharges imposed by surgeons who remove defective implants has not really been addressed, which is not acceptable either. Gilles Pargneaux gave us alarming figures for the number of victims of this criminal act perpetrated by PIP.

As regards the question I asked you on 13 January, you told me that the inclusion in the legislation on medical products of injected products or implants intended exclusively for aesthetic use was one of the options proposed by the Commission in a public consultation launched in 2008.

Commissioner, I should like to know exactly, in the context of the proposed revision of the legislation on medical devices, if you intend to extend the scope of this legislation to the aesthetic products in question.

When can we expect to have this legislation?

  Karin Kadenbach (S&D). – (DE) Madam President, Commissioner, I would like to follow on from that. We are talking today about medical devices, and I believe we need the strictest approval criteria for these, we need the most stringent checks and we need as much information as possible.

However, I am also convinced that only a minute proportion of the breast implants are actually being used as medical devices in the sense of medical treatment, and that the majority are used in cosmetic surgery. We are talking here about a market worth around EUR 700 million. My question today is therefore – and here I am following on from what Linda McAvan said – to what extent, as those responsible for health, we can justify the fact that a large number of Europeans, primarily women, have such a distorted self-image that they believe they will only really be a woman if they have such implants.

When you look at the fact that around 22% of young people in Europe, primarily women, suffer from eating disorders, and that the image of a young person conveyed to us in advertising and in the media – the image of a proper woman or a proper man – is an image that needs to be corrected if the upshot is that a large number of these people believe they can only restore their feelings of self-worth by means of surgical procedures, then we also need to give some thought to restrictions on advertising for the purposes of preventive health measures.

  Nicole Sinclaire (NI). – Madam President, this issue stems from the failure of the French authorities to regulate its manufacturing industry. Typically, ‘France has a take it or leave it’ approach to regulations that it expects other countries to adopt.

In June 2000, US medical regulators posted a warning letter on the Internet about problems at a breast implant maker in southern France. The French authorities did not pay this much attention. The French health authorities acknowledged as much in a 175-page report published on 1 February this year.

Radical change is needed in Europe to ensure proper surveillance of medical devices. France has shown itself incapable of regulating itself and should have external checks.

Many thousands of women have suffered, and are continuing to suffer, because of French negligence. France should be made to compensate all women affected by this negligence.

In future, there needs to be more communication with the surgeons, the clinics and the patients. These companies must be checked and the findings should be open to inspection by health professionals.

End of the catch-the-eye procedure

  John Dalli, Member of the Commission. – Madam President, I would like to thank all Members for their comments on this very important issue.

We all agree that patient health comes first and foremost in our policy deliberations. This is exactly what we are doing too when we insist that we must continue to have a flexible system that delivers innovation as fast as possible to our patients, because that is also a function of patient health.

Being able to use innovative products at the earliest possible time – and in Europe we deliver innovation about three years before our American counterparts with their own system – is a benefit to patients that we cannot put aside.

So when I was asked by Mr Pargneaux why I would not be pushing for pre-marketing authorisation, this is why: because I do not believe we need it. We do not need to go the way of pre-market authorisation. We have a system in Europe that has worked in the past. We are enforcing this system so it works even better. We are ensuring the competence of all the bodies that are involved in the authorisation process and this is the package that we will be proposing to this Parliament and to Council just after the summer. This, Mr Tarabella, is what the outcome is, and what my position is on this issue.

We have been deliberating, we have been studying and we have been stress testing what we have done because of the PIP case, and we will be coming forward with a formal, concrete proposal in a few months time, around September.

When we talk about authorisation, what we are saying here is: let us continue to keep the flexibility that we have in Europe; let us enforce and make sure that whoever is involved in the process is competent to do so; let us make the competent authorities in the Member States more involved in what is happening in their own countries within this process, and then let us have a Europe-wide expert group that will ensure the consistency, all across Europe, of a standard level of authorisation.

The PIP case is not about authorisation. The PIP case has nothing to do with authorisation. The PIP case is a fraud which could have happened under the most robust authorisation process you could possibly have.

The PIP case is an indication of the weaknesses we have in our processes: not necessarily in the legislation itself, though the legislation will be strengthened as well, but more in the way it was being implemented in market controls after authorisation.

As some of you have said, competent authorities in Member States simply let the medical devices that were in use in their countries not be subject to any kind of controls, and this is what is wrong.

It was unbelievable to hear – and I am an accountant by profession, so for me it was even worse – that all audits held by the notifying bodies on companies were all pre-notified two months in advance! It is unbelievable that this could happen!

This was all due to their interpretation that this was what was required in our legal process – which is not the case. In fact, in the letter I have written to the ministers, I have told them that this is not the case, that non-notified audits are provided for in our legislation today, and they should also be making sure that this is happening with marketing controls today. We do not need to wait two years until this legislative process that we will be launching very soon is finished.

We are pushing for transparency; transparency not only in the information that is given to everybody who might be deciding on making any type of procedure, but transparency also in the vigilance aspect so that all incidents that happen within the medical devices sector have to be reported back. A database will be set up to put all this information together so that we can really take the necessary actions.

The traceability of medical devices, which we are also proposing and will be proposing, as was mentioned here again today – and I am pleased that it was because this is also a very important aspect – and especially of risky medical devices, would also be part of the proposal.

Therefore, we are keeping our word on this. We will be coming back in September with a robust proposal that will drastically improve our safety issues – and without going overboard, without overreacting to an incident and trying to find a way of transmitting the sense that we are doing something by really doing something where it is not indicated that it needs to be done.

The problem of the PIP fraud was not authorisation. It lay in market controls, and this is where we need to really put our foot down and really ensure that we introduce a robust market control procedure.

  President. – I have received one motion for a resolution⁽¹⁾tabled in accordance with Rule 115(1) of the Rules of Procedure.

The debate is closed.

The vote will take place on Thursday, 14 June 2012.

Written statements (Rule 149)

  Véronique Mathieu (PPE), in writing. – (FR) The sale of defective silicone gel breast implants by the French company PIP is an absolute scandal. It is inconceivable that such a situation could continue for several years, that 400 000 breast implants were sold worldwide, without any reaction from the control and supervision chain. In the future, more stringent safety tests must prevent such a tragedy occurring again and help avert a situation where thousands of women are facing difficult situations in which their health is put at risk. European cooperation and the exchange of information in this regard must be strengthened.

(1) See Minutes