“Substantially Unsafe”: 30 disturbing facts about medical devices

Warning: you might need to go have a little lie-down after you take in the facts contained in a new Public Citizen report called Substantially Unsafe. You’d think that a medical device that’s  implanted inside your body should be at least as safe as a pill that you swallow, wouldn’t you? But this report warns that medical devices (such as pacemakers, heart valves, insulin pumps, cardiac defibrillators and orthopedic hip or knee implants) can actually pose a serious threat to patients, and that existing safeguards must be strengthened.

As a heart patient, I’m particularly alarmed by disclosures about cardiac devices – a category that’s been associated with significant problems. Implantable cardioverter-defibrillators (ICDs) are just one example.  Since 2009, the FDA has received reports of close to 29,000 deaths or injuries from implanted ICDs, by far the most for any medical device type, according to a Consumer Reports Health analysis of a federal database. The most troublesome aspect of the devices are the leads – the wires that connect them to the heart. See also: ICD Warning: Defective Defibrillator Leads Recalled.

Here are 30 highlights, or lowlights, of the Public Citizen report:  Continue reading