Sweden's health regulators want all women in the country with substandard PIP breast implants to have them removed over safety concerns. The move is a stark public policy decision that contrasts with regulatory advice in other places such as the United Kingdom, whose health officials determined the implants were otherwise safe, even if they ruptured more easily. And it comes as the world awaits the verdict in a French fraud trial involving 5 former executives from the company known formally as Poly Implant Prothèse.
The U.K.'s Daily Mail newspaper reports that the Swedish Medical Products Agency's recommendations follow similar actions in France, Germany and the Czech Republic, reflecting worries about the implants' long-term safety impact on what is a young segment of the population. Swedish patients or their private clinics will have to cover the removal costs themselves, according to the story.
The regulatory decision reflects the results of a study determining that some implants from the French company used a kind of silicone that irritates tissue. And those results followed a previous consumer group study that suggested chemicals from the implants could harm fetuses, the article explains.
Five former PIP executives, including founder Jean-Claude Mas, are awaiting the verdict of a fraud trial in France. They are accused of knowingly making the substandard implant, though they deny the charges. Their legal team is arguing for a gentle punishment, in part because testing of the implants has suggested they weren't toxic and that they didn't lead to higher breast cancer rates. But other experts now clearly disagree with that assessment.
Meanwhile, regulators across Europe are now considering tougher device approval standards in the wake of the PIP scandal.
- here's the Daily Mail article