Implanted cardiovascular devices and PIP breast implants, what have they in common?

21 Jan

Reading Alain Braillon’s blog is very informative. In a recent article in the Archives of Internal Medicine dated from December 13th, 2010 he compares the approval processes of human body implanted devices in the US and in France.

The brachiocephalic veins, superior vena cava,...

Image via Wikipedia

By the way I learned that devices permanently implanted in the human body do not automatically require that they be authorized through a Pre Market Approval (PMA). In fact, in most of the cases, a Pre Market Notification (that means which do not require any evidence of the absence of adverse event nor data on efficacy) is sufficient for the Federal Drug Administration (FDA) to give its approval to market the device (which means implant it permanently or for several years in your body). If PIP are under your skin, cardiovascular devices can be implanted in your big vessels like the Inferior Vena Cava filters.

A study has shown that, between 2005 and 2009, 31 % of the devices recalled by FDA after commercialization because of serious health problems or even death were cardiovascular devices.

Read more:

Medical Devices Approval Process a New French Exception? Presse Médicale. 2011;40:446-8

Medical devices & the approval processes: United States vs France Archives of Internal Medicine. 2010;170:2040-1

HEALTH CARE REFORM; INVITED COMMENTARY; Medical Devices and the FDA Approval Process: Balancing Safety and Innovation. By Rita F. Redberg, MD, MSc, Editor.

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