The notable risks in the use of bone cement • healthcare | 合法醫療器材資訊網

Initsguidancedocument(17July2002)theFDAstatesseriousadverseevents,somewithfataloutcome,associatedwiththeuseofacrylicbonecements, ...

The United States Food and Drug Administration (FDA) recognises that PMMA use has risks. In its guidance document (17 July 2002) the FDA states serious adverse events, some with fatal outcome, associated with the use of acrylic bone cements, including myocardial infarction, cardiac arrest, cerebrovascular accident and pulmonary embolism. In a public hearing on 28 April 1998, Hany Demain, a scientific reviewer in the Orthopaedic Devices Branch, reported on behalf of FDA that, since 1985, ‘95% of reported events related to PMMA were associated with death’.

Polymerisation of PMMA bone cement is an exothermic reaction, which occurs while the cement is hardening in situ. The released heat may damage bone or other tissues surrounding the implant. The liquid monomer is highly volatile and flammable. Ignition of monomer fumes caused by the use of electrocautery devices in surgical sites near freshly implanted b...