Tuesday, October 11, 2011

AMA Report Reveals 1 in 5 Heart Defibrillator Implant Surgeries Not Needed

The Journal of American Medical Association issued a report this week confirming 22,000 heart surgeries are performed each year in the United States that are not necessary. In fact, 20% of those little gizmos that send electric shocks to a heart that's not working up to par -- they are not needed.

The JAMA report reveals that over one in five heart defibrillators are implanted and they were totally not needed, or they were implanted by doctors who didn't bother to follow the guidelines on when they should be used. This is very, very bad.

Read the report, "Non-Evidence-Based ICD Implantations in the United States," here.

Medicine, after all, is big business. Consider this: even though the set standards for these implants remains that they should not be placed into the body of a person who has had recent bypass surgery, or a recent heart attack, nor should anyone diagnosed with a terminal illness or with chronic heart failure, doctors ignore the standards. Pooh-poohed them to the tune of 100,000 patients each year, according to the new AMA report.

Now, this is straight medical malpractice and something that can be the basis for a lawsuit under state malpractice laws. It's a different sort of case when we get to the second tier of this problem: the devices themselves.

What a nightmare to consider that some of these unnecessary heart surgeries involve defective products! However, it's happened. Consider the Contak Renewal ICD and the Ventak Prizm 2DR ICD products that were the subject of massive FDA recalls last year.

Some of the products are so bad that the Department of Justice filed a criminal complaint based on their flaws: last February, the feds sued Guidant, a wholly-owned subsidiary of Boston Scientific, for criminal violations of the Federal Food, Drug, and Cosmetic Act related to safety problems with some of its implantable defibrillators -- according to the Justice Department:
"Guidant concealed information from the U.S. Food and Drug Administration (FDA) regarding catastrophic failures in some of its lifesaving devices. The charges were filed following a four-year investigation into Guidant's handling of short-circuiting failures of three models of implantable cardioverter defibrillators (ICDs): the Ventak Prizm 2 DR (Model 1861) and the Contak Renewal (Models H135 and H155). Guidant issued safety advisories regarding the failures in June 2005."

So, Miami, what do you do about this?
If you or a loved one has had a defibrillator implant, then check to see what make and model it is against the FDA recall lists at the FDA site. If you find a match, then investigate removal or replacement options - learn from a trusted health care provider what is best for you to do at this point.

If you or a loved one are being advised to get heart surgery, get a second opinion. Ask what product they will be using, and again, investigate the product online. Remember, these are service providers - just like a mechanic for your car. Don't be intimidated and don't be worried about hurting their feelings.

Finally, if you think that you or a loved one may have been harmed by a defective heart implant, then investigate your legal options. You have a strict time deadline to file any kind of lawsuit involving medical injuries. Procrastinate, and the law may bar your claim, however worthy, as being filed too late.

By Bryant Esquenazi on January 6, 2011 8:59 PM

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