By Ruth Marsden - 24th January 2012
We need to put patient safety first
Linda McAvan
MEPs are calling on the European commission to ensure more traceability and unannounced inspections for the manufacturers of breast implants.
The call came during a discussion with commission representatives on Tuesday, following revelations that a number of silicone breast implants manufactured by French company Poly Implants Prostheses (PIP) were defective.
UK Socialist Linda McAvan said, "We need better traceability of implants. We need to put patient safety first."
MEPs welcomed the commission's announcement of stress tests to be carried out on the medical services directive's regulation of breast implants.
Representatives from DG Sanco explained how the EU is managing the aftermath of the PIP implants scandal, and outlined the steps it is taking to prevent it from happening again.
McAvan, who requested the commission's participation in the discussion, added, "I am very pleased the commission are looking at this. This is fraud. This company in France was hiding from regulations."
In March 2010, regulators heard that unauthorised industry-grade silicone was being used by PIP in the production of breast implants.
The company was closed down and medical authorities across Europe and Latin America began investigating whether more than 300,000 women who had received the implants had experienced health issues, including an increased risk of cancer when the substance had leaked.
EPP deputy Richard Seeber said, "Although it was a French company, the implants have been used across the whole of Europe, meaning 500,000 women could be affected. Patients across Europe need to feel secure."
Socialist MEP Dagmar Roth-Behrendt told participants, "It is a shame we're discussing medical devices in response to a scandal.
"But the main problem is the nominated agencies in member states. Do we need a different authorisation process for these products?"
Fellow S&D deputy Gilles Pargneaux warned, "We have to admit that we are facing a health scandal across Europe and we need some answers from the commission.
"In 2008 the US food and drug administration (FDA) raised questions with PIP and identified numerous problems. And in 2005 and 2006, complaints were raised in the UK about defections surrounding implants.
"It is only now since PIP has gone into liquidation that they are admitting these implants were cheaper than most," Pargneaux said.
Greens MEP Michèle Rivasi insisted that it was not up to the health authorities to ensure patient safety.
"Is it not the surgeon's responsibility? If they've got people coming back to them with burst implants, why didn’t they say anything?" she said.
Fine Gael MEP Mairead McGuinness highlighted two issues for the commission's consideration. "First, response time. We need a rapid alert time with things like this," she said. "The patient needs to feel reassured."
"Second, it is quite clear that this is fraud. Suppliers of industry silicone must be checked where they have sent the products," she warned.
Italian Socialist Mario Pirillo argued that PIP "should shoulder the responsibility".
"Around 30,000 defective implants will be removed in France, but what shocks me the most is that this company exported 80 per cent of its products to EU and Latin America."
ALDE MEP Frédérique Ries added, "As a consequence of this health scandal, the European commission has a duty to look into the 'business' of breast augmentation, and must immediately request a study on the possible health risks of silicone implants in general."
ALDE deputy Corinne Lepage said, "There should also be much stricter monitoring of this market. This requires a system allowing patients to directly report incidents.
"This scandal is further evidence of the need for a system of collective redress to assist consumers and patients in obtaining compensation."
Responding to the MEP concerns, Paola Testori, director-general of the commission's DG Sanco, said, "We are doing these stress tests in order to be able to avoid these types of cases in the future.
"We intend to reinforce surveillance and traceability and ensure all national authorities have some capacity of control.
"Unannounced inspections are necessary throughout the entire chain and we need a database containing full traceability, with authorised bodies acting in a similar way in all 27 member states," she added.
