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Article in Medicine / Physical Medicine & Rehabilitation / Prosthetics
Important patient health and safety issues remain concerning biomedical implants, which should encourage further efforts at consensus building.
 
 
 
<p>Parts for People: Biomaterials Experts Lack Consensus</p>

Article by Robert E. Baier, PhD, PE, State University of New York at Buffalo, based on data compiled by Karen Rittle & Gary Palmer, Biophysics PhD candidates.

There are very few situations where placement of biomedical or dental implants does not involve immediate exposure of those implants’ materials to contact with patients’ blood. It is to and through the blood/material interphase zones that all subsequent reactions of living cells with restorative, sensing, monitoring, stimulating and prosthetic devices must occur.

It has been surprising to find objections by reviewers and readers of a recently published Moment in History: Project Bionics article, Understanding Blood/Material Interactions: Contributions from the Columbia University Biomaterials Seminar (RE Baier and M Kurusz, ASAIO Journal 2012; 58:450-454) to consensus statements developed from over 20 years of prior debate and refinement by nearly 50 conferees from nearly as many technical disciplines. This unexpected and continuing confusion was foreshadowed in a 1978 Panel Conference report, Blood-Surface Interactions: Recognized Factors and Unsettled Questions (RE Baier and CK Akers, Vol. XXIV Trans. Am. Soc. Artif. Intern. Organs, pp770-773), as illustrated in these representative Delphi Survey response graphs:

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Delphi Survey Response Variations

The Delphi Survey process sought to insure systematic and anonymous collection of independent judgments, and development of a group consensus by decision-makers for biomaterials design criteria, without the risk of polite deference of the respondents to “senior experts” in the field. In preparation for the 1978 ASAIO Panel Conference, all members of ASAIO (American Society for Artificial Internal Organs) and of the Scientific Council on Thrombosis of the American Heart Association were provided with a checklist of 50 still-current dogmatic statements about the earliest events of contact implanted materials with living systems, on which to indicate their agreement or disagreement along a typical visual analog scale. The process was repeated a decade later, with over 1000 of these same checklists distributed to members of the US Society For Biomaterials and to the participants of the Gordon Conference on Biomaterials and Biocompatibilty, all acknowledged as “experts” in this still-emerging and important field of biotechnology. The unfortunate lack of consensus among these experts, judged from 7800 anonymous responses of these two additional expert groups not more tightly clustered than those from the previous 6000 responses, continues today as indicated by comments to the 2012 ASAIO article.

The file below provides—35 years later—the “School Answers” to the Delphi Survey questions asked, and the file at the bottom of the page summarizes the compiled data from the Society For Biomaterials’ expert member responses following a second decade of debate. Important patient health and safety issues remain, and should encourage further efforts at consensus building! Note the comments compiled at the end of the Delphi Survey response patterns and comments, where the critical remarks are made that such surveys should focus more on orthopedic issues. Certainly, this is true—given the numbers of artificial hips and related skeletal implants that are now being removed from the health care market because of significant failures of biocompatibility. Litigation over failed prosthetic devices should not be the preferred path to answering the critical materials/host interaction questions remaining.

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Click on the icon above to view the Delphi Survey "School" answers and comments.

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Used only with express written permission

Click on the icon above to view the Delphi Survey response patterns and comments.

IMPLANT RETRIEVAL AND ANALYSIS IS STILL REQUIRED TO MINIMIZE PATIENT RISK

Issued on January 18, 2013, the US Food & Drug Administration’s FDA MedWatch program published “Metal-on-Metal Implants: Safety Communication”, warning of adverse events of “pain, implant loosening, device failure and the need for revision surgery… symptoms or illnesses elsewhere in the body. Presently, the FDA does not have enough scientific data…”. Published on January 10, 2013, an article in the New England Journal of Medicine on “The 510(k) Ancestry of a Metal-on-Metal Hip Implant” noted that “Many medical devices that pose great safety risks to Americans, including metal-on-metal hip implants, currently enter the U.S. market through a Food and Drug Administration (FDA) regulatory pathway that is not intended for evaluating safety and effectiveness.”…..concluding “There would be value in an FDA-sanctioned registry.”

Sparked by Professor Jonathan Black, then Hunter Professor of Biomedical Engineering at Clemson University, steps toward creating this needed Registry—based on a robust Implant Retrieval and Analysis program—were described and debated by over 200 experts and representatives of stakeholder groups of patients and professionals in a 3-year worldwide project from 1994-1996, finally recommending a pilot program to provide the Public with the needed information. Contacted recently about prompting this long-delayed action by agencies and manufacturers, Professor Black offered “agreement, with the urging that you emphasize the need for minimum data sets (to produce maximal data quality!) and the commonsense idea of having the insertion and removal of ‘permanent’ implants automatically produce quasi-public data events, as human births and deaths do!”

Here, appended, is the Summary Report of the prior Implant Registry conference that reveals these important public health issues and recommends affirmative steps to overcome the still-occurring problems cited by FDA MedWatch and the New England Journal of Medicine.

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Click on the icon above to view "Implant Data: Record, Report, Review"

 

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Robert E Baier
Professor Bob Baier, State University of New York at Buffalo, is a PhD Biophysicist and Registered Professional Engineer specializing in con

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