- Posted October 16, 2013 by
This iReport is part of an assignment:
Shutdown over: What next?
- MORGAN LEWIS RESPONSE TO THE SENATE FINANCE COMMITTEE CONFIRMING THE FACT THAT THE OUTCOMES REGISTRY HAD NOTHING TO DO WITH THE MYXO ETLOGIX CLINICAL TRIAL
- 150 years later, newspaper retracts editorial panning Gettysburg Address
- OHRP FDA REGULATIONS FOR INFORMED CONSENT CLASSIFIES INVESTIGATIONAL DEVICES SUCH AS THE MYXO ETLOGIX MODEL 5100 UNDER THE LAWS WHICH REQUIRE FULL INFORMED CONSENT:
- FDA CONGRESSIONAL OFFICE ON JULY 16, 2009 OFFICIALLY CATAGORIZES THE MYXO ETLOGIX MODEL 5100, MANUFACTURED BY EDWARDS LIFESCIENCES AS INVESTIGATIONAL AND OF SIGNIFICANT RISK
- Northwestern University and Northwestern Memorial Hospital Elements of Informed Consent : HIPPA WAIVER DOES NOT APPLY TO FDA STUDIES subject to the FDA regulations at 21 CFR 50
Lawsuit Claims Surgeon Inserted Wrong Device Into Womans Heart Valve : Fraudulent Inducment
Northwestern University Ethics Review Approved Testing of Medical Devices in patients without informed consent
Permission to reproduce photo of the ring and patient's valve from the patients, published in the Myxo File Part VII, the Design History File: The Smoking Gun
2010 By Larry Yellen
"Toni Vlahoulis said she used to enjoy bike riding, walking and exercising. She was a healthy mother of two children.
Now she has trouble finishing a sentence.
During an interview, the north suburban woman admitted to getting short on breath.
Vlahoulis, an X-ray technician, said her problems began four years ago when doctors told her she needed open-heart surgery for a leaky valve. It would be performed by Patrick McCarthy, a prominent cardiac surgeon at Northwestern Memorial Hospital.
“Dr. McCarthy said he was going to try to repair my valve with a mitro valve ring," Vlahoulis said.
She now claims the ring he inserted was not the model of mitro valve ring she thought she was going to receive. As McCarthy points out in a web discussion for the Edwards Lifesciences company, he is not just a heart surgeon, he is also an inventor.
"First, I'll mention the disclosures," McCarthy said in the web discussion. "I am the inventor of the Myxo Etlogix Ring."
The Myxo Etlogix Ring is the ring that the doctor inserted into Vlahoulis' heart.
According to the Edwards Lifesciences video, "The Myxo ring offers surgeons a better option for these patients."
But in a malpractice lawsuit, Vlahoulis claims before she went under the knife, she was never told the Myxo Ring had not yet been approved by the Food and Drug Administration (FDA).
"I never wanted to be a guinea pig,” she said. “At the time I was 38 years old with two young kids."
Michael Burnett, her attorney, said, "McCarthy should have shown or disclosed to Toni that a device that he might put into her was an experimental device that he invented, that he received a royalty for."
Eventually, Vlahoulis had the ring removed and her heart was operated on by another surgeon. She does not claim the Myxo Ring malfunctioned, rather that she was part of an experiment she should have been told about.
Northwestern Memorial Hospital and McCarthy strongly disagree.
Neither McCarthy nor the hospital will comment on camera about the lawsuit. But they do defend their use of the Myxo Ring.
"We stand behind McCarthy," said a hospital spokesperson in a statement. The ring, she said, "was not considered experimental."
The Myxo Ring's manufacturer, Edwards Lifesciences, said the company "followed FDA's guidance in every respect."
But some experts said the FDA is the real problem here.
"It's very difficult to get a handle on how big a problem this is," said Dr. William Maisel of the Medical Device Safety Institute. He is also an assistant professor of medicine at Harvard.
Maisal told a congressional committee last summer that for two-and-a-half years, unsuspecting patients like Toni Vlahoulis received the Myxo Ring before it was FDA-approved.
That's because under current FDA guidelines, a medical device doesn't need to go through the FDA approval process if it’s only slightly different from a device that has already been approved. And it's the manufacturer who decides just how different it is, with guidance from the FDA.
"The reliance on manufacturers to make important determinations about the safety of medical devices is a loophole that should be closed,” Maisal said.
McCarthy used the Myxo Ring in more than 150 surgeries before the FDA took a closer look at the device and asked Edwards Lifesciences to pull it off the market. Vlahoulis was one of two patients to file lawsuits.
Eventually the FDA did determine the device was safe, and it's now on the market again. As for Vlahoulis, she's feeling only slightly better than she did before her surgeries, but she's glad the Myxo Ring has been removed.
A spokesperson for the FDA told FOX Chicago News that the agency is now reviewing the process by which devices like the Myxo Ring have been approved.""
Read more: http://www.myfoxtampabay.com/story/17850785/lawsuit-claims-surgeon-inserted-wrong-device-into-womans#ixzz2hvNoQXmJ
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