|A fresh U.S. Food and Drug Administration probe into adverse patient reactions to materials in medical devices, including breast implants, metal-on-metal hips and the birth control coil Essure, has been announced.|
|The FDA says it will hold a public hearing this fall into nitinol as part of the investigation into inflammatory and immune responses in patients; it will task its own scientists to conduct research on medical implant materials; and it will review published studies.|
Nitinol is an alloy containing nickel that is used in Essure. Many patients have reported allergic reactions to Essure and the U.S. Centers for Disease Control have estimated that between 10 and 20 percent of the population is allergic to nickel.
The agency will also consider patient responses to the silicone contained in breast implants in a previously announced hearing on breast implant safety due to take place on March 25-26.
“We believe the current evidence, although limited, suggests some individuals may be predisposed to develop an immune/inflammatory reaction when exposed to select materials,” the FDA said in its statement.
|Chavkin S||ICIJ, International Consortium of Investigative Journalists, Mar 18, 2019|
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