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(Circulation. 2005;111:2717-2719.)
© 2005 American Heart Association, Inc.

Editorial

Could It Happen Again?

The Björk-Shiley Convexo-Concave Heart Valve Story

Eugene H. Blackstone, MD

From the Departments of Thoracic and Cardiovascular Surgery and Quantitative Health Sciences, The Cleveland Clinic Foundation, Cleveland, Ohio.

Correspondence to Eugene H. Blackstone, MD, Head, Section of Clinical Research, Department of Thoracic and Cardiovascular Surgery, The Cleveland Clinic Foundation, 9500 Euclid Ave, F24, Cleveland, OH 44195. E-mail blackse@ccf.org

Key Words: Editorials • surgery • valves • mortality

An extract of the first 250 words of the full text is provided, because this article has no abstract.

	Introduction

 
Most readers of "Twenty-Five–Year Experience With the Björk-Shiley Convexoconcave Heart Valve: A Continuing Clinical Concern" in this issue of Circulation have not heard of the valve.¹ Many elements of its story parallel those of cerivastatin^2,3 and rofecoxib,⁴ but with a twist: Recalling a heart valve may entail greater risks than leaving a possible "time bomb" in place. The Björk-Shiley story raises many questions about balancing the benefits of drugs and devices with their risks to public safety. For example:

• Why was the device approved by the Food and Drug Administration (FDA) when catastrophic failure occurred in premarket trials?
  
• Once marketed, why was the device not withdrawn when catastrophic failures continued to occur?
  
• Why did the FDA approve engineering modifications when the failure mechanism was unknown (see Table 2 in the original article¹)?
  
• Were the expert scientists assembled by Shiley to discover the mechanisms of failure and devise diagnostic methods to identify patients at risk of failure as tainted as Circulation believed them to be?
  
• What is the scientific basis and optimal medical process for recommending removal of devices when the risks of doing so are high?
  
• Should the court have insisted that only large-volume, low-risk institutions remove them?
  

See p 2850

	My Involvement

 
My personal involvement began when a lawyer for Shiley, Inc, with a biostatistical degree read our account of the Braunwald-Cutter heart valve and wanted to understand why the University of Alabama at Birmingham and the Mayo Clinic decided to prophylactically remove every one.⁵ Subsequently, I served on scientific . . . [Full Text of this Article]

Related Article:

Twenty-Five–Year Experience With the Björk-Shiley Convexoconcave Heart Valve: A Continuing Clinical Concern

William J. Blot, Michel A. Ibrahim, Tom D. Ivey, Donald E. Acheson, Ron Brookmeyer, Arthur Weyman, Joseph Defauw, J. Kermit Smith, and Donald Harrison
Circulation 2005 111: 2850-2857. [Abstract] [Full Text]

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				G. Gerosa, R. Carta, M. Montisci, L. Leoni, S. Iliceto, G. Rizzoli, and F. di Marco How to deal with recipients of valves prone to structural failure in the 2000s: Padua experience with the TRI Technologies valve. Ann. Thorac. Surg., September 1, 2006; 82(3): 858 - 864. [Abstract] [Full Text] [PDF]