Heart valve prostheses: who protects our patients, and from what?

Phenomenal advances in the development of cardiac valve prostheses have taken place in less than two decades. However, the currently prevailing atmosphere of consumer protectionism in existence 20 years ago probably would have made such developments impossible. Recent passage of the Medical Device Amendments of 1976 (P.L. 94-295) will not only make future development extremely difficult, but also may force the field of cardiac valve replacement back into the era of the 1950s. Regulations implementing this legislation may be even more disastrous. It is time for someone to protect patients from their so-called protectors.