EXCLUSIVE: Faulty heart devices

The conversation is over a decade in the making

Surgery..

That's frightening enough, right?

Then imagine you find out an experimental device has been implanted in your body without your consent.

That's the reality for more than 700 patients who received surgery to fix leaky heart valves at northwestern memorial hospital in illinois.

Today the mayo clinic trainedá physician who has been fighting to shine a light on the truth spoke with kimt new three's jessica bringe á who joins us now with this kimt exclusive.

Jessica, what is being done today?

Xxx katie á after 12 years of fighting the food and drug administration is beginning to acknowlede the controversy..

I was in the room as dr. (naáleanáe) (rasháaámahná in) spoke on the phone with the fda..

It's an interview she's been working towards for more than a decade.

Xxx nats you're witnessing moments before a phone call..

More than a decade in the making.

It took a long time but i feel like i've done what i need to do to follow my vocation, follow my oath.

The journey to this day began back in 2006 when a clinical trial began to test an experimental heart valve at northwestern memorial hospital..

I am fighting for all the patients who received an experimental heart device, a research prototype that needed human testing before it was able to be launched on the u.s. market.

Dr. nalini (naá leanáe) rasháaá mahnáin says she became aware patients weren't being told they were guinea pigs for dr. patrick mccarthy's prototype in 2007..

When a 38áyear old patient began suffering severe complications that required a second open heart surgery at the cleveland clinic.

I reported that and at that moment it should have been a five minute conversation to tell my superiors that they could tell the few patients that had gotten the device and they did none of that.

Dr. al edwards was one of those patients.

The ring i have implanted in my chest i'm clearly convinced is investigational and not a cleared or approved ring.

Diagnosed with a heart attack in 2007..

Edwards was only made aware it was likely from the faulty heart valve in 2018 after onágoing cardiac issues.

The outcome i would like to see is to get this fully disclosed to all the patients so their healthcare givers can give them the correct sort of followáup and attention they need for these rings.

For the past 12 years dr. rashá aámahnáin has been fighting to get the fádá a to acknowledge the device wasn't cleared for use despite being sewn into the hearts of more than 700á patients to treat their valve diseases.

These are not minor injuries, there's strokes, there's heart attacks.

There's deaths there's reá operations.

You name it á it's happened.

This week á she got the chance to present her decades of research to the fda.

Failure by the fda to know that there were 122 product defects discovered in the prototype design.

These patients deserve to know what's going on.

Now the hope is all patients who received the faulty device will be notified so they can receive the care they i did reach out to the fádáa for comment but have yet to hear back.

Rasháaámanáin tells me she's not looking to take any legal actions..

She just want to do what's best for the patient's health.

Thank you jessica.

Again á at least 700 patients received the faulty device..

And all of those patients could be at risk for severe complications./ // an austin abuduction... how officers