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    Posted March 8, 2014 by
    NRajamannan
    Location
    Chicago, Illinois
    Assignment
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    This iReport is part of an assignment:
    I met a President

    More from NRajamannan

    We met President Obama on His Birthday in Chicago IL at the Cultural Center, August 5, 2010 and He accepts the Chicago Tribune Article to help the Citizens of Chicago

     

    http://www.triblocal.com/des-plaines/2010/08/05/fda-proposes-stricter-rules-on-approving-medical-devices/

     

    "By Deborah L. Shelton, Tribune reporter

     

    Prompted in part by a case involving a Chicago surgeon, the Food and Drug Administration is proposing stricter rules about redesigned medical devices, saying many should undergo more scrutiny before being implanted in patients.

     

    FDA rules have allowed companies to market such devices if they think the products differ only slightly from previously approved versions and are equally safe and effective. That provision, known as a 510(k) clearance, has come under sharp criticism as concerns have grown about the safety of implanted devices, which include replacement hip joints, pacemakers and drug pumps.

     

    One trigger for the agency’s review was a case involving Dr. Patrick McCarthy, a cardiac surgeon at Northwestern Memorial Hospital who implanted into patients a heart valve repair ring made by California-based Edwards Lifesciences. Two of the patients filed suit, claiming permanent injury. Both said they were unaware the heart ring was different from FDA-approved versions.

     

    McCarthy invented the ring, shares royalties and is a paid consultant to the manufacturer.

     

    After the ring came under scrutiny from the U.S. Senate Finance Committee, the company asked the FDA to review the device, and the agency granted approval last year. By then, the ring had been implanted into 667 patients. Neither the company nor Northwestern would say how many of those patients were at Northwestern.

     

    Northwestern contacted patients to reassure them the device was safe, and the company contacted hospitals and surgeons to offer an expert for questions. Neither the FDA nor the company has contacted patients to collect data on adverse outcomes.

     

    By the end of June, about two dozen “adverse events” complaints about the device, known then as the Myxo ETlogix 5100 annuloplasty ring, were reported to a FDA database, including two possible deaths. Annuloplasty rings are medical devices used in the surgical repair of the heart’s mitral valve.

     

    Northwestern and McCarthy declined repeated requests for interviews. A spokeswoman for Northwestern asked for written questions, then said the institution would not answer them.

     

    An FDA spokesman said no action would be taken against the company, hospital or surgeon “because they made a good faith effort” to comply with regulations that were ambiguous.

     

    But some patient advocates said such mistakes should be swiftly punished.

     

    “The message should be, there are procedures and we expect you to follow them, and there is a price to pay if you don’t,” said Arthur Levin, director of the Center for Medical Consumers, a nonprofit patient advocacy organization. “Even if it was inadvertent, you have to send a message to other manufacturers that it’s not an excuse.”

     

    “It is the very core of our ethical responsibility as physicians to inform patients that they were subjected to a clinical trial,” said Dr. Nalini Rajamannan, a Northwestern cardiologist who first raised concerns about the Edwards heart ring to the FDA and the Senate Finance Committee. “This ethical responsibility goes back to the Hippocratic oath.”

     

    As the population ages, an increasing number of Americans are being implanted with medical devices that treat cardiac, orthopedic and other health problems. But in recent years, incidents involving several high-profile devices raised questions about the FDA’s ability to properly evaluate and monitor their safety and effectiveness.

     

    Patient groups, health professional organizations and insurers have criticized the agency for taking too long to identify safety problems and for failing to implement stronger scientific standards for device clearance and approval.

     

    Dr. Jeffrey Shuren, director of FDA’s Center for Devices and Radiological Health, said at a briefing that the proposed rules will help manufacturers know what is expected, make clear which devices will be required to undergo regulatory review and clarify when clinical or manufacturing data are required.

     

    “These reports and recommendations have a great deal of promise that can save a lot of lives,” said Diana Zuckerman, president of the National Research Center for Woman & Families, a nonprofit research and education center. “The question is, will they be allowed to happen, or will it be politics as usual?”

     

    In a written statement, Stephen Ubl, president and CEO of the Advanced Medical Technology Association, said the recommendations could mean some disruptions for the industry but praised them overall.

     

    It’s virtually impossible for patients to know in advance if the medical device that will be implanted in them has not been properly approved or tested, Levin said. “Patients go into (surgery) in good faith, assuming that rules and regulations are followed and their best interest is protected,” he said.

     

    Maureen Obermeier of Chicago contends that Northwestern did not tell her she had suffered a heart attack on the operating room table after her valve ring was implanted in November 2006. She later received a surgically implanted pacemaker and defibrillator and has filed suit against McCarthy, Northwestern, Northwestern Medical Faculty Foundation and Edwards Lifesciences.

     

    “We put all of our faith in our health care institutions,” said Obermeier’s attorney, Ardwin Boyer. “They care for our sick family members, and the vast majority of them are outstanding, devoted people who deserve our utmost respect and admiration. This is really sad.”

     

    Antonitsa Vlahoulis of Niles, who suffers from a life-threatening mitral valve disorder, said the valve ring permanently damaged her heart, requiring her to undergo additional surgeries to implant a mechanical valve device and later a pacemaker.

     

    A hearing on reinstatement of her lawsuit, recently dismissed on a technicality, is scheduled for Monday in Cook County Circuit Court.

     

    “I want to make sure that anything (surgeons) implant has FDA approval and is done with the patient’s consent and knowledge,” said Vlahoulis. “You want to be confident and not worry that what they might do is unethical.”"

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