Don’t Let Possibly Faulty Pumps Puncture the Heart

Target: Dr. Robert Califf, Commissioner of U.S. Food & Drug Administration

Goal: Take stronger action against heart pumps reportedly linked to multiple patient deaths.

A heart pump placed inside over 300,000 critically ill patients worldwide comes with some serious—and perhaps lethal—health risks, according to reports. The Impella pump, made by a company under the ownership of Johnson & Johnson, has been potentially linked to nearly 50 deaths. Possible complications catalogued over the past several months include malfunction, arterial bleeding, and even tears in the heart.

Criticism of the device is longstanding. Experts have questioned the lack of credible studies and results to back up its efficiency, as well as the company’s apparent delay in reporting problems and complications. Critics also wonder if the high payments made to medical professionals who promote and use the device could play into its continued use despite the documented issues. For its part, the company that created the device blames “operator use” for the more serious complications.

The Food and Drug Administration has issued a high-level alert regarding this pump. It represents the third such warning related to Impella devices in recent times. The alert discourages use of the pump on patients with certain serious ailments, but the problem is that every patient needing this pump is critically ill, often due to massive heart attacks. The FDA has yet to enact the next logical step of taking this device off the market.

Sign the petition below to demand implementation of this potential life-saving step until more rigorous and robust studies can be conducted.

PETITION LETTER:

Dear Dr. Califf,

Abiomed’s Impella heart pumps service 60,000-plus patients in the United States alone. Each patient depends on this device to literally sustain their life. The device was touted as a more reliable solution to balloon-style pumps, but multiple studies have seemingly shown a troubling, high mortality rate. Almost 50 deaths may be associated with this device (that coincidentally carries a higher price tag and a higher pay-out), which means tens of thousands of Americans could be living with a ticking time bomb in their chests.

These patients deserve better than a wait-and-see approach, when waiting could cost them their lives. Impella has already been linked with FDA warnings three times, so let this third strike be the out. Pull this product from the market until and unless true efficacy can be established. Protect the most vulnerable and sickest patients from undue, seemingly preventable harm.

Sincerely,

[Your Name Here]

Photo Credit: Stephanie C. Torres Ayala


One Comment

  1. This seems to be an issue of life and death. One can assume there will be some failures but not this amount of failures! If the pumps are not effective they need to not be used until they are fully functional. Everyone has problems in a situation like this. Insurance rates will go up. People will die from the pumps not working as intended. This is not a accident. All cases will end in court or as a massive settlement. This is like an evil wind which blows no one any good.

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