A breast implant register, more stringent safety checks, improved product traceability, and a pre-market authorisation system are among the measures proposed by the European Parliament on Thursday to prevent a recurrence of the PIP defective breast implants case. The relevant EU legislation is to be revised this year.
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 regulatory system
In a resolution adopted by a show of hands, MEPs argue that 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". EU legislation in this area is to be revised this year.
A pre-market authorisation system
The European Commission is asked to switch to a pre-market authorisation system for certain medical devices, including breast implants.
Passport and registers
MEPs call for the introduction of an implant recipient's "passport", stating the implant's specific characteristics and its potential adverse effects, and also a breast implant register, in each Member State. The text stresses that the inclusion of a patient’s personal details should be subject to their consent.
These national registers should be interconnected to allow information exchange 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 also advocate stepping up checks, inspections, market surveillance and information sharing on adverse effects, so as to ensure improve medical device traceability and follow-up. Patients, too, must be made aware of breast implant risks, says the text.
A European data base
A single European data base should be established to bring together information about medical devices on the market, the registration of economic operations, vigilance and market surveillance; clinical investigations, notified bodies (which check compliance with EU rules) and EC certificates issued, say MEPs.
Procedure: Oral question + resolution