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Parliamentary questions
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15 April 2019
Question for written answer E-001832-19
to the Commission
Rule 130
Ivo Belet (PPE) , Esther de Lange (PPE) , Annie Schreijer-Pierik (PPE)

 Subject:  Liability for leaking breast implants
 Answer in writing 

Last week, France decided to ban certain breast implants as a precautionary measure because they may be carcinogenic. Dutch surgeons have now also decided not to use these implants any more.

In its reply to Question E-000426/2019 on the problem of silicone breast implants, the Commission refers to potential liability of manufacturers and notified bodies under Directive 85/374/EEC on liability for defective products.

1. Can the Commission confirm that breast implants which, after a period of time, begin to leak, thus presenting health risks, while patients have not received sufficient prior information about these potential effects, fall within the definition of ‘defective products’? The recent decisions in France and the Netherlands suggest so.

2. Does the Commission agree that on the basis of case-law, including preliminary ruling C-503/13 on the replacement of pacemakers, manufacturers are liable for the consequences of leaking breast implants and for the costs associated with the health problems they can cause, both to patients and to the public authorities?

3. Is liability for faulty products borne partly by the notified bodies which have performed conformity assessments and approved the products?

Original language of question: NL 
Last updated: 2 May 2019Legal notice