EU to tighten medical controls after breast implant scandal

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.

"We must do our best never to let this happen again," said EU Health and Consumer Policy Commissioner John Dalli, outlining plans for more transparent regulations "better adapted to scientific and ."

The new rules will cover every device, from the simplest plasters to life-support systems by way of in vitro diagnostic instruments, to ensure that they are correctly approved and then monitored in use.

Earlier this year, the French government recommended that faulty breast implants which were prone to rupture made by Poly Implant Prothese (PIP) should be removed.

More than 400,000 women around the world are believed to have received and many countries followed the French lead after the company was found to have used substandard, industrial-grade .

"Everybody was shocked by the scandal ... (which) damaged the confidence of patients, consumers and in the safety of the devices on which they rely every day," Dalli said.

Asked whether his regulations would have prevented the PIP scandal, he said they would "militate against such fraud" but the key issue was that once they were sold there had been no follow up to check the implants.

"What we want to emphasise is" the control of products once they are in use to check that they are made to the specifications laid down and approved, he said.

"If this had happened, the PIP would have been detected many, many years before."

The proposals mean medical devices will now have to undergo a "thorough assessment of safety and performance before they can be sold on the European market," with "control processes ... radically reinforced," a statement said.

The aim is to give healthcare professionals better information on the benefits and risks while manufacturers will benefit from clearer rules, with those not complying excluded from the market.

The market in the 27 EU states plus Norway and Switzerland was worth 95 billion euros in 2009, the statement said.

The proposals now go to the European Council and the European Parliament for approval.

add to favorites email to friend print save as pdf

Related Stories

Recommended for you

US must respond to global health outbreaks, say bioethicists

10 hours ago

Last summer, West Africa fell into the grip of a deadly outbreak of Ebola that has thus far taken the lives of more than 9,500 people. The fear swept up by the epidemic quickly jumped across the Atlantic and landed in the ...

Uganda on defensive over medical 'brain drain' uproar

Mar 03, 2015

Uganda's government on Tuesday hit back at mounting criticism of plans to 'export' over 200 health workers to the Caribbean, insisting it was only seeking to regulate an existing labour market and prevent abuses.

Seth Mnookin on vaccination and public health

Mar 02, 2015

Seth Mnookin, an assistant professor of science writing and associate director of MIT's Graduate Program in Science Writing, is the author of "The Panic Virus: The True Story Behind the Vaccine-Autism Controversy" ...

User 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.