A breast implant register, more stringent safety checks, improved product traceability, and a pre-market authorization 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.
Faulty silicone breast implants made by the now-defunct French company Poly Implant Prothese (PIP) had triggered health concerns among tens of thousands of women worldwide, mostly in Europe.
EU Scientific Committee estimates that around 400,000 PIP silicone breast implants were sold worldwide. These implants were widely used in the United Kingdom, France, Spain and Germany, where respectively around 40,000, 30,000, 10,000 and 7,500 women were implanted with PIP silicone breast implants.
An investigation warranted by an unusually high short-term breast implant rupture rate has revealed that PIP fraudulently made use of industrial silicone instead of the approved medical grade one. The product was withdrawn from the EU market in 2010 in the wake of the death from cancer of a woman who had received a suspect implant, and the breast implant company was forced to close down for using substandard silicone gel.
In a resolution adopted by a show of hands, MEPs argued 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.
The European Commission is asked to switch to a pre-market authorization system for certain medical devices, including breast implants.
MEPs called 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 obtain compensation, says the resolution.
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.
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.
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