|Printable version||E-mail this to a friend|
PIP breast implants: "learn the lessons of this fraud"
A breast implant register, more stringent checks and product traceability, and a pre-market authorisation system are among the measures proposed by the Environment and Public Health Committee on Wednesday to prevent a recurrence of the PIP defective breast implants case. The resolution was passed unanimously.
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.
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.
Failure of the compliance notification system
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".
"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", say MEPs.
Improve traceability and coordination
"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, says the resolution.
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", says the text.
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, it adds.
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, say MEPs.
A pre-market authorisation system
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, says the text.
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.
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, they add.
Finally, a system of collective redress should be put in place to help patients to obtain compensation, says the text.
MEPs call for transparency in the functioning of notified bodies
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.
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, they add.
A European data base
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, say MEPs.
Latest News from
Taxation: Study confirms billions lost in VAT Gap25/10/2014 09:10:06
An estimated €177 billion in VAT revenues was lost due to non-compliance or non-collection in 2012, according to the latest VAT Gap study published by the Commission recently.
Click and learn with the EMCDDA’s new-look Best practice portal24/10/2014 14:05:44
Real-life responses to drug problems come under the spotlight yesterday as the EU drugs agency (EMCDDA) launches its revamped Best practice portal (1).
Human rights: closing down of Russian Memorial NGO; Uzbekistan; Mexico24/10/2014 13:10:03
Parliament passed three resolutions on Thursday, calling on the Russian authorities not to close down the Memorial civil rights NGO; urging the Uzbek authorities to take immediate action to protect human rights; and calling for the immediate arrest of all those responsible for the disappearance of 43 students in Mexico.
EP position on the 2015 EU budget23/10/2014 16:20:34
European Union member states must back their political pledges with money to revive growth, create jobs, encourage research and development, and enable the EU to do its foreign policy job, said MEPs as they reversed the Council's cuts in the draft EU budget for 2015 on Wednesday. An agreement on additional funds for 2014 is a prerequisite for Parliament to do a deal on next year's budget with Council, MEPs added.