Sunday

21st Apr 2019

Breast implants scandal to see tougher EU legislation

The European commission aims to strengthen oversight of companies that certify medical devices following a breast implant scandal thought to have affected at least 400,000 women worldwide.

The low-grade breast implants produced by the now closed French manufacture Poly Implant Prothese (PIP) were made available in nearly all member states with the largest concentration in the United Kingdom, France, Spain and Germany.

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  • Commission aims to introduce tougher EU legislation on medical devices (Photo: wikipedia)

The implants - containing silicone made for use in mattresses - were banned in 2010 but France caused waves in December last year when it issued a cancer alert and advised French women to have the implants removed.

The European Commission reacted by calling for a report by its scientific committee. Its findings, published Thursday (2 February) have been inconclusive.

The report found that “data available today was insufficient to lead to firm conclusions regarding the health risks for women with PIP silicone breast implants”. The evidence of health risks for women with PIP silicon breast implants, it concluded, is weak.

The study instead confirmed that the non-medical grade silicone found in the implants can weaken the casing and cause leaks but that toxicity tests performed on the gel are inconclusive. Instead, it said the leaks can cause irritation.

“In the current situation, patients’ health remains the priority. The opinion published today sums up the current scientific knowledge on this case,” the European commissioner in charge of consumer policy, John Dalli said in a statement.

But proven fraud, possible sub-standard screening processes in Europe, and recent revelations that the United States Federal Drug Administration (FDA) banned the company in 2000 are causing concern among MEPs in the European parliament.

PIP obtained a permit for its saline implants in 1997 from the German certification company, TUV Rheinland. The manufacturer declared a medical-grade silicone but instead used an industrial alternative that is around ten times less expensive saving the company around €1.2 million per year, according to Reuters.

The FDA issued a warning letter to the company's founder, Jean-Claude Mas, and then banned PIP saline implants in the United States in 2000 after inspecting the manufacturer’s premises in southern France. The FDA agent who inspected the site in 2000 said the implants had been “adulterated”, according to press reports.

But the FDA apparently failed to inform the French authorities because of alleged confidentiality issues. The same plant in southern France was manufacturing the silicone implants generating the current uproar.

Jörg Meyer of TÜV Rheinland told this website by email: “Neither the FDA nor PIP informed us about the warning letter. When viewed retrospectively the warning letter provided no indication that criminal activities were taking place within PIP. Nevertheless, it would be better if the supervisory authorities were to inform each other of the results of such inspections and then also to pass on this information to the notified bodies such as in this case TÜV Rheinland.” The company annulled PIP’s certificate in March 2010.

But a EU-US confidentiality agreement only applies to cases issued in 2007 to the present. Anything before 2007 does not have to be disclosed to authorities.

"The American FDA already banned PIP products in 2000. It's difficult to believe that the FDA was investigating a factory in France and the EU didn't know," said UK Socialist MEP Linda McAvan.

No EU-wide traceability

Some of the sub-standard implants were branded under different names making it difficult to trace the manufacturer back to PIP. The 30,000 figures cited for France and the 40,000 to 50,000 figure cited for the United Kingdom are only rough estimations because of the traceability problem says the commission.

Authorities are unable to determine which people received which implants.

In Denmark, one clinic closed and destroyed all its documents once it was discovered that it had used some PIP implants. The women treated at the clinic have no idea if they are carrying anyone of the implants classified as potentially dangerous.

McAvan is now pushing for a EU-wide system that improves traceability of the implants and wants the commission to implement an EU-level barcode that identifies every item.

For its part, the commission is currently revising a EU-wide legislation on medical devices with a view to obliging national authorities to strengthen privately-run companies that inspect medical products.

There are between 70 and 80 such companies in Europe and the commission wants them all to use the same set of standards when certifying and inspecting medical devices. Other proposals include unannounced spot checks and additional sample testing of products already on the market.

The commission expects to adopt the new legislation on medical devices this spring.

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