L'Affaire Pip Prompts Stress Test
3 February, 2012
Following publication of a study
on 2 February that "sums up current scientific knowledge on the [Pip] case," in the words of Health and Consumers Commissioner John Dalli, the European Commission has announced that it will engage EU member states in a discussion on how medical device surveillance can be reinforced within existing legislation. Notably, the discussion will touch on further recourse to unannounced inspections, greater oversight of Notified Bodies and additional sample testing of products on the market.
The Commission has also called for further study of the potential health impact of faulty breast implants and has confirmed that a "stress test" on current legislation is underway. The lessons learnt will inform the recast of the medical device directives that is underway, added Dalli in a press release issued by the Commission.
The aforementioned report
, published by the Scientific Committee on Emerging and Newly Identified Health Risks, an independent advisory body of scientific experts established by the Commission, came to the following conclusions:
- there is concern regarding the possibility of inflammation induced by ruptured Pip silicone implants
- further study should be conducted to ensure that potential health risks are properly established, quantified and managed
- Pip implants varied considerably in composition
- Many Pip implants were made with nonmedical-grade silicone, which may contain components that can weaken the implant shell and diffuse into body tissue.
Patient safety, as Dalli stressed, remains the priority. No argument there. Industry must be vigilant, however, that this dreadful event does not lead to an erosion of the "new approach" principle in respect to medical device legislation. Don't let perfect be the enemy of good, as I noted in a recent editorial, Pip Implant Scandal: Fix What’s Broke. Then Stop
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