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    Posted January 17, 2014 by
    Chicago, Illinois

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    Chicago Tribune Reports Head of FDA Device Section Jeffrey Shuren Admission: Investigational Heart Rings Implanted in Patients between 2003-2008 without FDA approval



    "Antonitsa Vlahoulis knew as she slipped into unconsciousness on the operating room table that her surgeon would choose which medical device she would receive to fix her leaky heart valve.


    But when a warranty card arrived in the mail for the device stitched into her heart, Vlahoulis got the first of several shocks.


    The card referred to the device by its original name: the McCarthy Annuloplasty Ring. That's when she realized that Dr. Patrick McCarthy, her surgeon at Northwestern Memorial Hospital, had invented it.


    Vlahoulis, of Niles, said McCarthy had told her he would choose a ring from those listed in a booklet he gave her. She flipped through it, but this ring wasn't there.


    She checked the Food and Drug Administration's website, looking for the ring on the agency's list of approved devices. But she couldn't find it. When she contacted the FDA to ask about it, she received a startling email in reply.


    "Due to our confidentiality concerns we are unable to provide any information about a product until after it is approved," the public affairs specialist wrote.


    "Oh my God," Vlahoulis remembers thinking. "I can't believe this."


    Patients in need of permanently implantable, life-sustaining medical devices may assume that the products have undergone rigorous clinical and regulatory scrutiny and that rules put in place to protect their rights are enforced to the letter of the law.


    But that wasn't the case at Northwestern and other hospitals where two different annuloplasty rings co-invented by McCarthy were sewn into the hearts of more than 700 patients to treat their valve diseases over a number of years though the FDA didn't clear the rings until 2009.


    The situation highlights the tangled web of interests patients face when they require medical devices not just at Northwestern but across the U.S., showing what can happen in a profitable industry with few controls and plenty of gray areas.


    It's especially true when doctors study their own inventions using data from their patients, who don't always know of the potential conflicts of interest.


    That's what happened at Northwestern, and it's a cautionary tale that centers on two questions: Were the rings experimental? And was McCarthy conducting clinical research on one of his inventions while receiving royalties or other payments from the manufacturer?


    McCarthy is a world-class heart surgeon who has saved thousands of lives, improved the well-being of countless patients and made weighty contributions to the art and science of cardiac surgery. His recruitment to Northwestern from the Cleveland Clinic in 2004 was a coup, instantly making the hospital one of the nation's premier cardiac centers.


    In an interview, he said the rings' manufacturer had told him they were cleared for use under FDA rules. The hospital received those same assurances, a spokeswoman said.


    In fact, the company — California-based Edwards Lifesciences — had not submitted the rings to the agency for review. It would later argue, incorrectly, that doing so was not necessary under FDA regulations.


    McCarthy, who does about 150 valve surgeries a year, said that at the time he had no knowledge of the rules governing medical devices and that he relies on industry and the FDA to ensure the ones he uses are safe and effective.


    "There are no guideposts for us," he said. "You don't learn about this stuff in med school."


    He also said he had stopped telling patients some of the heart rings he uses were his inventions because most didn't seem interested in such details.


    The controversy over the device Vlahoulis received triggered an FDA investigation that found Edwards should have sought FDA clearance before allowing surgeons to use two of its annuloplasty rings. But the agency took no action against the company, saying it had "made a good faith effort" to follow the law, and soon allowed the devices back on the market.


    "Essentially, what happened here is that they bypassed the federal regulatory system in its entirety," said Vera Hassner Sharav, president of the Alliance for Human Research Protection, an education and advocacy group. "The fact that FDA gives the rings a stamp of approval after all of this only compounds the problems."


    $100 billion industry


    The case of the annuloplasty rings also raises questions about the roles and responsibilities of doctors and hospitals, who stand between patients and the $100 billion medical device industry.


    For patients with valve disease, the stakes are high. To repair valves, their chests are opened, their hearts are stopped and the life-sustaining device is stitched into the valve while a heart-lung bypass machine keeps them alive.


    Vlahoulis said she hunted for information about her ring because she had complications following her April 2006 surgery. What she discovered did not set her mind at ease.


    She told her cardiologist, Dr. Nalini Rajamannan, that she had not consented to receive an experimental, or "investigational," device or to be part of a study about the ring.


    As co-author with McCarthy on a study of the ring — renamed the Myxo ETlogix — Rajamannan thought the device was experimental and that patients had given consent to receive it.


    She said she immediately paged McCarthy to tell him that patients didn't know they had gotten an experimental device — or that they were part of his research on the ring. She also contacted hospital and Northwestern University officials, according to documents she provided to the Tribune. The university oversees research at Northwestern that involves human subjects.


    Rajamannan urged the hospital and university to investigate, but they told her Edwards Lifesciences had assured them the ring did not need clearance because it was a minor modification of an existing device.


    "Neither Dr. McCarthy nor Northwestern Memorial Hospital has any motivation to do anything other than what is in the best interest of its patients, required to ensure patient safety and is required by the law," spokeswoman Holli Salls said last week.


    With patients still getting the ring, an alarmed Rajamannan contacted the FDA in July 2008.


    After carrying out its investigation, the FDA told Edwards Lifesciences officials that fall that the company should have sought FDA clearance because the ring's shape and material made it different from other rings on the market. The company voluntarily recalled the ring and applied for clearance.


    Edwards Lifesciences officials declined to be interviewed but said in a statement: "Edwards followed FDA's guidance relative to our (Myxo) annuloplasty ring and Edwards addressed the requests from FDA and resolved them more than two years ago."


    In January 2009, Northwestern hospital's president and CEO, Dean Harrison, sent a letter to Vlahoulis and other patients who had received the Myxo ring. It stated that "we do not consider this device to be experimental."


    The hospital said Harrison's information was based on an email received from Edwards Lifesciences in August 2007, after the devices had been implanted, saying the Myxo "is not an investigational device."


    Yet according to the FDA, between the time the Myxo ring first was being implanted and the time it was cleared, about three years, it was an investigational device.


    "If a device is supposed to get cleared by the agency first before you're marketing it, we consider that investigational," Dr. Jeffrey Shuren, head of the FDA's medical device branch, told the Tribune.


    The Myxo was cleared in April 2009 under yet another name, the dETlogix, along with another Edwards ring used at Northwestern and other hospitals, the IMR ETlogix.


    In May, Harrison wrote a second letter to patients, saying the agency had cleared the ring. What patients wouldn't know from reading his letter is that the FDA considered the device investigational...

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