EU takes steps to improve breast implant safety

April 5, 2017

The European Parliament on Wednesday adopted measures to improve medical safety in the wake of the worldwide scare over faulty breast implants from France.

The measures adopted after nearly five years of debate aim to ensure devices like breast and can be traced, meet EU patient requirements, and face tighter approval procedures.

The assembly in Strasbourg, France also approved laws to tighten up information and ethical requirements for diagnostic medical devices, such as pregnancy or DNA testing.

"We've introduced much stricter requirements for the bodies that authorise medical devices," said Glenis Willmott, a British member of the Socialists and Democrats group who steered the bill through the European Parliament.

Willmott said in a statement that supporters "will insist that particularly high risk devices, such as implants, joint replacements or insulin pumps, be subject to additional expert assessments before they can be authorised".

The measures, for example, require patients be given a card allowing them and doctors to trace which product has been implanted, the European Parliament said in a statement.

The conservative European People's Party, the largest bloc in , said the new EU rules had been agreed on between Parliament and the 28 member states and will enter into force by mid-2020.

A court in the French city of Toulouse in January ordered German safety certifier TUV to pay 60 million euros ($64 million) in compensation to 20,000 women who received defective breast implants that the group had approved.

TUV Rheinland was ordered to make a provisional payment of 3,000 euros to each plaintiff for certifying that implants made by French firm Poly Implant Prothese (PIP) met safety standards.

In the far-reaching health scandal, the devices were later found to contain substandard, industrial-grade silicone gel that was seven times cheaper than medical-grade silicone.

Explore further: Breast implant victims win payout from German safety body (Update)

Related Stories

Breast implant victims win payout from German safety body (Update)

January 20, 2017
A French court on Friday ordered German safety certifier TUV to pay 60 million euros ($64 million) in compensation to 20,000 women who received defective breast implants that the group had approved.

EU lawmakers move to tighten controls after implant scare

October 22, 2013
The European Parliament moved Tuesday to tighten controls on the safety of medical devices in the wake of a worldwide scare over faulty breast implants from France.

Court clears German safety body in breast implant scare

July 2, 2015
A French appeals court on Thursday cleared German safety standards body TUV of liability in a faulty breast implant scandal, meaning hundreds of women will have to pay back damages they received.

German firm on trial over faulty French breast implants

March 22, 2013
Proceedings against a German safety standards firm that gave defective breast implants the all clear kicked off Friday in France, with millions of euros claimed in damages.

EU to tighten medical controls after breast implant scandal

September 26, 2012
A breast implant scandal affecting thousands of women this year damaged confidence and highlighted the need to tighten controls in Europe on everyday medical devices, the European Commission said Wednesday.

EU improves safety of implants after PIP scandal

September 24, 2013
The EU's executive on Tuesday moved to improve the safety of medical devices in the wake of the worldwide scare over faulty PIP breast implants from France.

Recommended for you

Cold open water plunge provides instant pain relief

February 12, 2018
A short, sharp, cold water swim may offer an alternative to strong painkillers and physiotherapy to relieve severe persistent pain after surgery, suggest doctors in the journal BMJ Case Reports.

Study spotlights risks in anesthesiologist handoffs

February 9, 2018
Most patients are totally unaware that the anesthesiologist who put them under for surgery might not be the same one who brings them out even though that 'handoff' between the two doctors has been linked to a series of negative ...

One in five older adults experience brain network weakening following knee replacement surgery

February 7, 2018
A new University of Florida study finds that 23 percent of adults age 60 and older who underwent a total knee replacement experienced a decline in activity in at least one region of the brain responsible for specific cognitive ...

New algorithm decodes spine oncology treatment

February 6, 2018
Every kind of cancer can spread to the spine, yet two physician-scientists who treat these patients describe a paucity of guidance for effectively providing care and minimizing pain.

Patients and doctors often disagree in evaluation of surgical scarring

February 1, 2018
When it comes to the physical scars surgery leaves behind, a new study shows patients and doctors often don't assess their severity the same way. Researchers from the Perelman School of Medicine at the University of Pennsylvania ...

Boosting a key protein to help bones that won't heal

February 1, 2018
When a patient breaks a bone, there's a possibility the fracture won't heal properly or quickly—even with the aid of pins, plates or a cast.

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.