9. Urges the Commission to give specific attention to female genital mutilation as part of an overall 
strategy for combating violence against women, including joint action against female genital mutilation;  
10. Urges the Commission to make it a priority to end violence against women and girls and, through 
the allocation of appropriate financial resources, to support targeted and innovative programmes both 
within the EU and in third countries;  
11. Urges the Member States to take firm action to combat this illegal practice;  
12. Instructs its President to forward this resolution to the Council, the Commission, the UN Secretary- 
General and the Member States.  
Defective silicone gel breast implants made by French company PIP  
P7_TA(2012)0262  
European Parliament resolution of 14 June 2012 on defective silicone gel breast implants made by 
French company PIP (2012/2621(RSP))  
(2013/C 332 E/18)  
The European Parliament , 
— having regard to Article 184 of the Treaty on the Functioning of the European Union,  
— having regard to the Council conclusions on innovation in the medical device sector (  1 ), 
— having regard to Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (  2 ), 
— having regard to Council Directive 90/385/EEC of 20 June 1990 on the approximation of laws of the 
Member States relating to active implantable medical devices (  3 ), 
— having regard to European Parliament and Council Directive 98/79/EC of 27 October 1998 on in vitro 
diagnostic medical devices (  4 ), 
— having regard to Directive 2000/70/EC of the European Parliament and of the Council of 16 November 
2000 amending Council Directive 93/42/EEC as regards medical devices incorporating stable derivates of 
human blood or human plasma (  5 ), 
— having regard to the opinion of the Scientific Committee on Emerging and Newly Identified Health Risks 
(SCENIHR) on ‘the safety of silicone products manufactured by the Poly Implant Prothèse (PIP) 
Company’ published on 1 February 2012 (  6 ), 
— having regard to the conclusions (  7 ) of the High Level Health Conference on innovation in medical 
technology held in Brussels on 22 March 2011,  
— having regard to its resolution of 13 June 2001 on the petitions declared admissible concerning silicone 
implants (Petitions 0470/1998 and 0771/1998) (  8 ),EN 15.11.2013 Official Journal of the European Union C 332 E/89  
( 1 ) OJ C 202, 8.7.2011, p. 7.  
( 2 ) OJ L 169, 12.7.1993, p. 1.  
( 3 ) OJ L 189, 20.7.1990, p. 17.  
( 4 ) OJ L 331, 7.12.1998, p. 1.  
( 5 ) OJ L 313, 13.12.2000, p. 22.  
( 6 ) http://ec.europa.eu/health/scientific_committees/e merging/docs/scenihr_o_034.pdf  
( 7 ) http://ec.europa.eu/consumers/sectors/medical-device s/files/exploratory_process/hlc_en.pdf  
( 8 ) OJ C 53 E, 28.2.2002, p. 231.  Thursday 14 June 2012
— having regard to its resolution of 2 February 2012 on ‘Towards a Coherent European Approach to 
Collective Redress’ (  1 ), 
— having regard to Directive 2007/47/EC of the European Parliament and of the Council of 5 September 
2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States 
relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices 
and Directive 98/8/EC concerning the placing of biocidal products on the market (  2 ), 
— having regard to the question of 18 April 2012 to the Commission on defective silicone gel breast 
implants made by French company PIP (O-000101/2012 – B7-0118/2012),  
— having regard to Rules 115(5) and 110(2) of its Rules of Procedure,  
A. whereas according to the findings of the French health authorities, a French manufacturer (Poly Implant 
Prothèse) is under investigation for the fraudulent use of low-quality material (industrial silicone) 
different from the material indicated in the documents submitted for conformity assessment 
(approved medical-grade silicone);  
B. whereas there is a lack of both clinical and epidemiological data on the potential risks of PIP breast 
implants;  
C. whereas for third-generation implants there is a rate of rupture within ten years of implantation of 
10-15 %;  
D. whereas tests conducted by the French authorities on the physical integrity of a sample of PIP silicone 
breast implants indicated weaknesses in PIP shells not found in other commercially available implants;  
E. whereas the SCENIHR report requested by the Commission in early January 2012 stresses that there is 
some concern regarding the possibility of inflammation induced by ruptured or leaking PIP silicone 
implants;  
F. whereas the lack of EU-wide registration of breast implants means that the overall number of women 
who have received implants is unknown; whereas, however, it is estimated on the basis of the available 
data provided by the European Commission that around 400 000 PIP silicone breast implants have 
been sold worldwide; whereas many women in the United Kingdom (40 000), France (30 000), Spain 
(10 000), Germany (7 500) and Portugal (2 000) have received PIP silicone breast implants;  
G. whereas patients need to know that implants are not permanent and may need to be replaced or 
removed; whereas patients also need to be informed about the quality of implants and the potential 
risks associated with them;  
H. whereas the transposition of EU legislation on medical devices into national legislation has not 
prevented this health fraud, which has had, and will continue to have, a serious negative impact on 
health worldwide;  
I. whereas this health fraud has brought to light a malfunction at the European and national levels, 
notably as regards the lack of cooperation between Member States and the international community in 
terms of information sharing and notification of adverse effects, and lack of traceability of raw material 
used for medical devices;EN C 332 E/90 Official Journal of the European Union 15.11.2013  
( 1 ) Texts adopted, P7_TA(2012)0021.  
( 2 ) OJ L 247, 21.9.2007, p. 21.  Thursday 14 June 2012
J. whereas the case of PIP implants, like the case of hip implants, illustrates the failure of the current 
system of certification of compliance with essential health and safety requirements and of the control 
and surveillance of notified bodies by national competent authorities pursuant to the Medical Device 
Directive (2007/47/EC);  
K. whereas the desire to provide swift access to new medical devices for patients must never take 
precedence over the need to ensure patient safety;  
L. whereas the Medical Device Directive (2007/47/EC) will be reviewed in 2012; whereas it is essential 
that lessons be learned from the fraudulent marketing of PIP implants such that surveillance and safety 
controls and requirements for placing products on the market are strengthened at national and at 
European level;  
M. whereas the available data indicate that many PIP implants have been manufactured from non-medical- 
grade silicone containing components that can weaken the implant shell and diffuse into body tissues;  
1. Notes that several Member States have advised patients to consult their surgeon, or have recom ­
mended patients to have breast implants made by PIP removed as a precaution;  
2. Notes, however, that inequalities exist between Member States as some have given their citizens 
conflicting advice as to what action to take, causing confusion among patients;  
3. Calls on the Commission and the Member States to strengthen their cooperation within the existing 
legal framework, in particular in the fields of market surveillance, vigilance and inspection, and to tighten 
controls, in order to provide a better guarantee of safety of patients, especially those exposed to high-risk 
medical devices;  
4. Stresses that after carrying out an assessment, Member States must immediately inform the 
Commission and the other Member States of measures that have been taken, or are being contemplated, 
to minimise the recurrence of such incidents;  
5. Calls on the Commission to develop an appropriate legal framework to guarantee the safety of breast 
implants and of medical technology in general;  
6. Calls for the introduction and implementation of essential and immediate specific measures on the 
basis of the current legislation on medical devices, in particular designed to:  
— strengthen the controls on medical devices already on the market, including those using samples;  
— ensure that, in the context of the conformity assessments, all notified bodies make full use of their 
powers to conduct frequent (at least once per year) unannounced inspections of the whole supply chain 
and of the operations of certain suppliers, notably suppliers of medical devices associated with the 
greatest risks and those in relation to which users’ reports indicate that the number of incidents is 
growing;  
— strengthen the criteria for accreditation and assessment of notified bodies – with particular emphasis on 
the demonstrated competence of full-time staff, the use of contract resources, and transparency with 
regard to their functioning and tasks – and set up an EU-wide qualification management system for 
notified bodies, their staff, auditors and experts;  
— reinforce market surveillance by, and information sharing between, national authorities to monitor the 
adverse effects of medical devices and the withdrawal of such devices from the market, in order to 
guarantee better traceability of medical devices and better follow-up of measures to control their 
marketing;EN 15.11.2013 Official Journal of the European Union C 332 E/91  
Thursday 14 June 2012
— improve supervision by national authorities of notified bodies and ensure consistency across Member 
States;  
— encourage innovation in medical technology, as innovation is crucial to efforts to overcome the health 
challenges of today and tomorrow;  
— require manufacturers of medical devices to communicate immediately to their national competent 
authority any ban, restriction or legal action under way in one or more Member States;  
— improve the functioning of the vigilance system for medical devices, for example by facilitating and 
actively encouraging patients, patients’ associations, patient groups and healthcare professionals to report 
all adverse events and harmful effects to the competent authorities, without their being hampered by 
excessive red tape, by giving notified bodies systematic access to reports of adverse events and by setting 
up a centralised procedure for gathering and treating notifications on adverse effects and on the with ­
drawal of devices from the market;  
— establish tools that, while providing data protection, ensure traceability of medical devices and long-term 
monitoring of their safety and performance, such as a ‘Unique Device Identification’ system, an implant 
register and a summary of product characteristics for each medical device;  
— facilitate notification of national authorities by patients’ associations and health professionals regarding 
adverse effects;  
— establish a single European database that brings together information about the medical devices available 
on the market, registration of economic operations, vigilance and market surveillance initiatives, clinical 
investigations, notified bodies and EC certificates issued;  
7. Calls on the Commission to shift to a system of pre-market authorisation for certain categories of 
medical devices, including, at least, medical devices of class IIb and III;  
8. Calls for the introduction – where it does not already exist at national level – of an implant recipient’s 
passport specifying the unique product code of the implant, its special characteristics and potential adverse 
effects, and bearing a warning of the potential health risks and post-operative follow-up care measures 
associated with the implant; the passport would have to be signed by the surgeon and the patient, and 
would be valid as a consent form for the operation;  
9. Recommends that hospitals should keep an electronic version of the passport for future reference, 
noting that an electronic version can easily be forwarded at the request of a patient to a new care facility, 
whether in the same or in a different country;  
10. Calls on the Member States to raise awareness more effectively of the potential risks attached to 
cosmetic surgery, and to better regulate the advertising of cosmetic surgery in order to ensure that patients 
are fully aware of the risks as well as the benefits; stresses that women should be made aware that breast 
implants need to be replaced after a period of time that varies from person to person, enabling them to 
assess risks more effectively;  
11. Recognises that patients who have already received breast implants may need retrospective 
information, advice, medical supervision and counselling, as well as screening for intra- and extra- 
capsular rupture;  
12. Stresses that the testing procedures and standards for breast implants should be refined to allow a 
better understanding of the interaction of the shell material with the filling gel and the surrounding body 
fluids, and of the fatigue and tear resistance of the shell and the total implant; considers that more proposals 
should be made for research to develop non-destructive methods of testing of implants;EN C 332 E/92 Official Journal of the European Union 15.11.2013  
Thursday 14 June 2012
13. Urgently recommends that details of breast implant operations be recorded in the EU in the form of 
a compulsory National Breast Implant Register in each Member State; underlines the fact that a compulsory 
register would make reporting mandatory for all clinics, but stresses that the inclusion of a patient’s 
personal details should be subject to their consent; recommends that such national registers be intercon ­
nected and allow for exchange of information when needed, for example in cases where significant defects 
are detected in implants;  
14. Urgently recommends a revision of the Medical Devices Directive aiming at introducing a capacity to 
detect and minimise the risk of fraud, focusing in particular on provisions regarding market surveillance, 
vigilance, and the functioning and tasks of notified bodies, so as to avoid a repetition of the PIP case;  
15. Calls on the Commission to consider the possibility of establishing an efficient tracking system for 
medical devices used as implants, particularly for the most dangerous medical devices such as those in 
class III;  
16. Calls on the Commission to consider the following aspects in the upcoming revision of the legis ­
lation on medical devices: the need for a marketing authorisation request for dangerous medical devices 
which complies with, or is similar to, the requirements for medicinal products; use of mandatory 
unannounced inspections; the need for increased traceability of implanted medical devices; the need for 
increased coordination between Member States when it comes to reporting on, and warning about, serious 
side effects or damage caused by medical devices; enhanced control of notified bodies; and additional sample 
testing of products already on the market;  
17. Calls on the Commission also to consider, in the upcoming revision of the legislation on medical 
devices, the need for adequate human testing during clinical trials, particularly of implantable medical 
devices, before they are put on the market;  
18. Urges the Member States to carry out, at least annually, thorough unannounced inspections of those 
medical devices that are associated with the greatest risks and of those devices in relation to which users’ 
reports indicate that the number of incidents is growing;  
19. Urges the Member States to apply penalties in case of non-compliance;  
20. Considers that this fraud provides further evidence of the need for a system of collective redress 
designed to help consumers and patients to obtain compensation, as stressed by its above-mentioned 
resolution of 2 February 2012;  
21. Calls on the Member States to pool their adverse incident reports and other regulatory data in the 
centralised database, as required by the Medical Devices Directive, in order to enable more effective vigilance 
and health protection measures;  
22. Calls on the Commission to require adequate toxicological assessments of all medical devices, and to 
propose that the use of substances that are carcinogenic, mutagenic or toxic for reproduction (category 1A 
or 1B) be phased out, unless no substitutes are available;  
23. Instructs its President to forward this resolution to the Council, the Commission and the parliaments 
of the Member States.EN 15.11.2013 Official Journal of the European Union C 332 E/93  
Thursday 14 June 2012