Strong Orthopaedic Surgeon Serves on NIH Panel for Improving Medical Implant Retrieval, Analysis

March 01, 2000

Heart pacemakers, artificial joints, intraocular lenses, and other medical implants are widely used in the United States, where an estimated eight to 10 percent of the population has been fitted with a medical implant. However, medical implant recipients often have unrealistic expectations of the risks and benefits associated with those implants, a technology assessment panel convened by the National Institutes of Health (NIH) has concluded.

Kenneth E. DeHaven, M.D., professor in the Department of Orthopaedics at the University of Rochester's Strong Memorial Hospital, was one of 14 experts who served on the NIH panel.

The independent, non-federal panel consisted of experts from the fields of medicine, engineering, law, and academia. The group heard presentations on opportunities for and the challenges of developing a formal system for retrieving and analyzing these devices. The lack of such a system has impeded research in this area.

Retrieval and analysis of medical implants provides critical information for improving design and function, and is vitally important to improving the care of patients who need implants, the panel concluded in a statement released at the end of the NIH Technology Assessment Conference titled Improving Medical Implant Performance through Retrieval Research Information: Challenges and Opportunities. The conference was held in January at the NIH in Bethesda, Maryland.

To address issues regarding patient expectations, the panel recommended that the informed consent process prior to receiving an implant include discussion of benefits, risks, potential complications, expected longevity of the device, need for follow-up, and possible future examination of the implant. The panel also urged that attention be directed toward reducing legal and economic discentives to medical implant retrieval and analysis. The panel also stressed the need for comprehensive education programs to inform the public and professionals about the importance of implant retrieval and analysis.

In its conclusions, the panel noted that tissue engineering is emerging as a new and promising area of medical implant science and recommended that the U.S. government begin active preparation and planning to construct the new regulatory protocols required by this new class of implants. In addition, the panel called on NIH to develop an aggressive research and development program to ensure continuing advances in medical implant science.

The NIH Consensus Development Program was established in 1977 as a form of "science court" to resolve, in an unbiased manner, controversial topics in medicine. To date, NIH has conducted 111 such conferences addressing a wide range of issues important to health care providers, patients, and the general public.

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