FDA Review May Target Materials Used in DePuy Hip ... | 合法醫療器材資訊網

2019年11月25日—AbouttheDePuyHipImplants...TheDePuyPinnacleAcetabularCupSystemwasmadeofmetalonmetal(MoM)construction.Themetalused ...

The FDA has begun an extensive investigation into the materials used in medical implants such as DePuy hip[1] prosthetics.

The investigation, which was begun in March, is focusing on the scientific methods used to evaluate materials used in hip implants[2] and other implantable medical devices. It is also addressing the question as to why some patients react badly to these materials, while others suffer no adverse effects.

In an official statement, former FDA Commissioner Scott Gottlieb said, “Enhancing our collective understanding of materials science could lead to identifying materials that may cause an exaggerated response in sensitive individuals and advance the development of safer materials.”

Due to the high amount of reported reactions to metal implants, in November 2019 the Food and Drug Ad...