New FDA statement on metal-induced adverse reactions from implants

October 1, 2019 - melisa_wpa

Comments are off for this post.

In November, FDA will discuss the topic of immunological responses to metal-containing products regulated as medical devices. The discussion will focus on metal-containing implants as well as dental amalgam. The meeting will be held on November 13 and 14, 2019.

From the statement: “Recent postmarket issues with some metal-on-metal orthopedic implants and gynecological metal-containing implants have raised questions about the potential for some patients to develop unexpected or heightened biological responses to the implant.”

“The agency is seeking expert advice on which patient characteristics or metal properties may put an individual at higher risk for developing an adverse reaction, and what research could be conducted to better understand the issue and minimize risk.”

Full statement can be read here

In the document “Biological responses to metal implants“, FDA mentions MELISA (no other LTT test is specifically mentioned).

They quote our research and also write “Under optimal conditions, LTT can identify adaptive response to a metal implant.”