Expert Panel Identifies Major Challenges and Opportunities for Improving Medical Implant Retrieval and Analysis

John Bowersox,, NIH Office of Medical, Applications of Research, [email protected] Danzig,, National Heart, Lung,, and Blood Institute

Heart pacemakers, artificial joints, intraocular lenses, and other medical implants are widely used in the United States, where an estimated 8 to 10 percent of the population has 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.

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

"Many people understand that medical implants improve quality of life, " said panel co-chair, Edward N. Brandt, Jr., M.D., Ph.D. of the University of Oklahoma Health Sciences Center. "Far fewer recognize the importance of retrieving and analyzing medical implants when they fail or no longer are useful."

Retrieval and analysis of medical implants provides critical information for improving implant design and function and is vitally important to improve care of patients who need implants, the panel concluded in a statement released at the end of a NIH Technology Assessment Conference titled Improving Medical Implant Performance Through Retrieval Research Information: Challenges and Opportunities. The conference was held January 10-12, 2000 in the Natcher Conference Center on the NIH campus in Bethesda, Md.

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 disincentives to medical implant retrieval and analysis.

The panel stressed the need for comprehensive education programs to inform the public and professionals about the importance of medical implant retrieval and analysis.

"The NIH has an exceptional opportunity to improve care of patients with implants by providing education to all parties involved in the process," said Julia R. Weertman, D.Sc., panel co-chair, of Northwestern University. She added that retrieval analysis should be conducted with the full collaboration and participation of the medical device industry.

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 full NIH Technology Assessment Statement on Improving Medical Implant Performance Through Retrieval Research Information: Challenges and Opportunities, is available by calling 1-888-NIH-CONSENSUS (1-888-644-2667). The statement also will be posted to the NIH Consensus Development Program Web http://consensus.nih.gov by Thursday, January 13, 2000.

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 controversial medical issues important to health care providers, patients, and the general public. An average of six conferences are held each year.

The conference was sponsored by the NIH Office of Medical Applications of Research and the National Heart, Lung, and Blood Institute. Conference cosponsors included the NIH Biomaterials and Medical Implant Science Coordinating Committee, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, the National Institute of Dental and Craniofacial Research, the National Institute of Neurological Disorders and Stroke, the National Library of Medicine, and the National Institute of Standards and Technology.

NOTE TO RADIO EDITORS: An audio report of the conference results will be available from 4:00 pm ET January 13, 2000 through January 21, 2000 from the NIH Radio News Service by calling 1-800-MED-DIAL (1-800-633-3425) or by visiting http://www.radiospace.com/nihhome.htm on the Web.