“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

Why isn’t California disciplining its dangerous doctors?

Until he was banned in California from operating in 1967, Dr. Walter Freeman performed over 3,500 "ice pick lobotomies" through his patients' eye sockets.

You’d like to think that the doctor trusted to make treatment decisions for you or your family members would be in big trouble if he/she were found guilty of practice violations like “delivering substandard care, wrongly diagnosing surgical patients, improperly leaving surgical equipment in a patient, alcohol/substance abuse, or physical illness/impairment”.  But such is not the case, according to the non-profit watchdogs over at Public Citizen, who claim that the state of California has become delinquent in disciplining 710 physicians with documented records like this.

In fact, 102 of these California doctors have been designated by peer reviewers as an “immediate threat to health or safety” of patients – yet are still allowed to practice medicine in the state.  One question: are their patients aware of this?

Here’s the report:  Continue reading