Glenis Willmott MEP, Labour’s leader in Europe, said: “The PiP scandal shows we needed tougher regulation of medical devices. Many women did not know if they had been given the potentially dangerous breast implants or not, because of the lack of a traceability system, causing stress and anxiety for thousands.
“This week is Breast Cancer Awareness Week, and we have to think of those women who had survived breast cancer, only to be put through the ordeal of having potentially dangerous implants removed.
“That is why we are introducing a system using unique identification numbers, so every device can be traced and recalled if there is a fault.
“The metal-on-metal hip implant scandal shows that we need much more rigorous testing of medical devices before they are used on patients.
“Although many concerns have been raised over years about serious health problems caused by debris from metal-on-metal hip replacements, hundreds of thousands of patients have been implanted with them, and they still remain available on the market in some places.
“Many of these patients will need to be monitored for the rest of their lives.”
Labour MEPs supported pre-market approval of medical devices, including anything implanted into patients, such as breast implants or pacemakers, but Tory and Liberal Democrat MEPs watered it down at committee stage after aggressive industry lobbying, and plans were further weakened in yesterday’s vote.
“In vitro” medical devices
There was also a separate vote on a new regulation for in vitro medical devices.
Labour MEPs have ensured new rules for these diagnostic tests will not stop the UK from going ahead with plans for over-the-counter HIV tests, something AIDS campaigners and sexual health charities have long campaigned for.
Glenis Willmott MEP added: “Many people at risk of HIV infection may not feel able or willing to ask their doctor for an HIV test – a quarter of people with HIV do not know they are infected, so it is vital we increase access to tests, especially among vulnerable groups.
“Advice and counselling always needs to be available, but forcing people to discuss the issue with their doctor will deter a lot of people from getting tested at all.”