This article is part of our special report Medical devices regulation.
French surgeons have fitted 650 people with replacement hips that had not yet been certified as meeting European standards, health officials said on Thursday (2 May). The case resembles last year's scandal over faulty breast implants, which triggered a revision of the EU's legislation on medical devices.
Though health officials said there was no reason to believe that the uncertified prosthetics posed any health risk, according to the French news agency AFP, the surgeons involved have been asked to carry out checks on the patients concerned.
While awaiting the outcome of the checks, an investigation has been launched into the manufacturer, a company called Ceraver.
Meanwhile, around 1,000 artificial hips have been withdrawn from circulation, the French agency for medicine safety (ANSM) said.
Ceraver is one of France's biggest manufacturers of medical devices with an output of around 3,000 prosthetic ankles, hips, knees and shoulders a year.
Last month, criminal fraud proceedings over a breast implants began in France.
The French firm Poly Implant Prothèses (PIP) allegedly used cheap, industrial silicone not intended for medical use for breast implants. Some 400,000 women have been affected globally.
PIP, which was once the third biggest global supplier of breast implants, is accused of cutting costs for 10 years by using an illegal homemade concoction of industrial-grade and agricultural silicone.
EU legislative update
The European Parliament is currently debating how to update the EU's directive on medical devices.
In her draft report, German Parliament rapporteur Dagmar Roth-Behrendt (Socialists and Democrats) said the procedure for getting the devices on the market in the EU has shown substantial weaknesses over the past years and needs a shift.
These weaknesses include a lack of transparency and swift approval and placing on the market despite insufficient investigations on patients and therefore insufficient clinical data. This is putting patients at risk, the rapporteur stated in the report.
Background
'Medical device' covers a wide range of products both used internally and externally by patients and doctors.
They can include sticking plasters, contact lenses, pregnancy tests, dental filling materials, X-ray machines, pacemakers, breast implants, hip replacements and HIV blood tests.
These are intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment and prevention of disease.
They are a ranked from Class I, a low-risk category that would include spectacles, to high-risk Class III items such as hip replacements and pacemakers.
Timeline
- Spring 2013: Members of the Parliament's environment committee to debate draft report by Roth-Behrendt MEP on medical devices
Further Reading
EU official documents
- European Commission: Amending medical devices directive regulatory proposal
- European Commission: Notified Bodies for Medical Devices
- European Commission: Medical devices: European Commission calls for immediate actions
- European Parliament: Draft report on the proposal for a regulation of the European Parliament and of the Council on medical devices