Word: implants
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Dates: during 1980-1989
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...process--should be 100-per-cent effective, compared to grafting's success rate of 65 per cent, Julie Glowacki, head of the research team that developed the new process and an associate in surgery at the Med School, said last week. Using the new process, doctors implant demineralized bone matter into the site where bone growth is desired. The implant then causes existing non-skeletal tissue cells to change into skeletal tissue cells...
...also wondered whether the patient consent forms proposed by the Utah doctors fully spell out the kind of life the implant recipient should expect. The heart runs on compressed air and is electrically powered. That means the patient will be permanently tethered to air hoses and plugged into an electrical outlet, a sedentary, chair-to-bed existence...
...agency cited several problems with the proposal. First was concern over when and how doctors would decide to implant the plastic and aluminum device. The Utah team said it would try the procedure only as a last resort, when a patient's heart could not take over for the heart-lung pump used during surgery. But the FDA suggested that the doctors first consider using a less drastic mechanical aid, the so-called assist device. This piece of equipment leaves the natural heart intact but takes over the operation of one of the pumping chambers, usually the left ventricle...
Another issue is the difficulties posed by the bulky support equipment, including a refrigerator-size air compressor. Says Cheitlin: "There was discussion about the logistics of getting the power source into the operating room and eventually into the home. What about backup systems for the home?" Some implant recipients may later be considered for heart transplants at Stanford University. "How," asks Cheitlin, "will they get them from Utah to California...
Finally, the FDA believes the proposal does not go into enough detail on what, if any, information will be gathered after the implant. Will the researchers, for example, record the effect on the blood, measure exercise tolerance of the patient, or monitor the new heart's pumping ability...