A popular heart pump used on cardiovascular patients has now been linked to dozens of deaths and possibly hundreds of injuries – but the FDA refuses to pull the device from the market. Mike Papantonio & Farron Cousins discuss more.
Transcript:
*This transcript was generated by a third-party transcription software company, so please excuse any typos.
Mike Papantonio: A popular heart pump used on cardiovascular patients has now been linked to dozens of deaths and possibly hundreds of injuries. But the FDA refuses to pull the device from the market. No surprise to me. I mean, how many times have we said, yeah, you got an organization that doesn’t work. The FDA is dysfunctional. Now lay the case out. Lay this out and let’s talk about it just a little bit.
Farron Cousins: Yeah. This is involving the Impella heart pump, which is a small little device that they implant into the heart of heart patients undergoing surgery. It’s a temporary implant. It does not stay in permanently. And what the FDA has found over and over and over again is that this thing is tearing the walls of the heart. And when that happens, I think it’s what, 80 to 90% fatality rate.
Mike Papantonio: You’ll die. You will die. There’s no question you will die. And there’s, is there an alternative? Yes. There’s something called a balloon pump. They don’t need this thing that they put in the heart. It ends up, as you can imagine, it tears into the artery. Once it tears in the artery, you cannot stop the bleeding there on the operating table.
Farron Cousins: They have minutes to act before its death.
Mike Papantonio: Okay. You are gonna think I’m making this up right now. But you read this story. Viewers are gonna think I’m making this up, but it’s right here in the story. The FDA said, oh, we have the solution. Let’s put somewhere in the warnings that this might happen. This is a warning to the doctor. It’s not a warning to the patient. The warnings are this big. Okay. So the patient’s supposed to say, well, let me see all the warning. No patient does that, especially when they’re under anesthesia and they decide we’re gonna use this thing. This is the mentality of the FDA. They are so owned and operated by the pharmaceutical industry, that it’s beyond belief. And so medical device industry, same thing. And they’re all looking for another job, Farron, they all wanna say, oh yeah, well let’s give these people a pass. Let’s let ’em keep using this thing that’s killed what, 46 people?
Farron Cousins: Yeah.
Mike Papantonio: 46 people have died. Other people have barely just barely gotten away with their lives. And they say, well, we’re gonna keep it out there because these, what we call key opinion leaders from Harvard or Yale and Princeton are out there on the speech circuit saying, well, this isn’t so bad. And all you have to do is ask yourself this. There’s already something on the market that prevents this. It’s called the balloon pump. It does exactly what this thing’s supposed to do. Okay. But the FDA says, no, there’s no risk here because we’re gonna warn, somewhere in the warnings is this issue. The patient has no way of knowing that. Has no way of saying, doc, wait a minute. Don’t put this in my heart. Right?
Farron Cousins: Yeah. And another thing about it too is the FDA does what they usually do. They say, okay, we know it’s killing people. We’re gonna slap our warning on there. And when the public comes asking about it, we’re gonna say, we need more studies.
Mike Papantonio: Yes.
Farron Cousins: We need more time. And in that time, people will die. That’s what’s happening. And you have cardiovascular surgeons before the warning was put on that have now spoken to the press that said.
Mike Papantonio: We told them it was gonna be.
Farron Cousins: I’m not, I won’t use it because of how dangerous this is.
Mike Papantonio: And we told ’em it was gonna be a problem.
Farron Cousins: Yeah.
Mike Papantonio: And at the same time, you have these medical whores or science whores that are coming from Harvard and Yale and Princeton. They pay ’em a million dollars and they say, doc, would you go out and talk about how brilliant this is and how important this is? And of course they sign up. Yeah, I’ll be glad to do it for a million dollars because I’m only making a quarter of a million dollars, but I’ll say any thing for a million dollars. That’s what’s happening in that case.
Farron Cousins: Absolutely.
Mike Papantonio: And unfortunately, the FDA’s not gonna fix it because they’re dysfunctional. They don’t, the FDA doesn’t work. And we believe it works, but it doesn’t. Just like the EPA and SEC, doesn’t work.
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