US to Investigate Health Impact of Nickel, Silicone in Medical Implants
US to Investigate Health Impact of Nickel, Silicone in Medical Implants
By SASHA CHAVKIN / March 18, 2019
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.
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Last fall, the International Consortium of Investigative Journalists reported extensively on breast implants, Essure and metal-on-metal hips as part of the global Implant Files investigation of the medical device industry and its overseers. ICIJ’s coverage examined regulators’ refusal to recognize adverse reactions to these devices among patients, including breast implant illness, an ailment reported by many breast implant patients characterized by chronic fatigue, muscle pain and cognitive difficulties.
More at the link.
https://www.icij.org/investigations/implant-files/us-to-investigate-health-impact-of-nickel-silicone-in-medical-implants/