Thread by @sashachavkin

Covering today’s FDA hearing on immune responses to metal-containing devices for ⁦@ICIJorg⁩. The hearing will address Essure, metal hips, dental implants & more, but will focus on larger question of risks from metals that can cause immunological reactions

@ICIJorg Risk of corrosion in metal devices is tested in labs (in vitro) and commonly used metals like titanium and cobalt do well, says Dr. David Saylor of the FDA. But in vitro tests don't capture mechanical stress or inflammatory responses, and far less data on corrosion in the body

@ICIJorg There is a major gender disparity in reactions to metals with women suffering more serious effects, says the FDA's Dr. Steven Weber. One study found 97% of those w adverse responses were women. Women also more likely to suffer arthritis & other rheumatic responses.

@ICIJorg Hearing turns to risks of mercury used in dental amalgams. FDA has found insufficient evidence of association to act on patient harm from mercury amalgams. I spoke to a dentist this morning who is here to demand stronger regulation - because dentists are getting mercury poisoned!

@ICIJorg "This is a real thing" - Dr Karin Pacheco of University of Colorado School of Medicine presents study on metal reactions in joint replacements, finds that patients w adverse responses who get metal implants replaced have significant improvements

@ICIJorg “This is not just a metal-on-metal problem," says Dr Stephen Tower, orthopedic surgeon who suffered severe cobalt poisoning from his own hip implant. “We are seeing this with many popular hip designs that are still commonly implanted.” Read his story here
nytimes.com/2018/01/13/opi…

@ICIJorg Dr. Tower offers scathing indictment of FDA's handling of metal hip poisoning issue, saying it showed greater concern for health of industry than of patients. "I am tired of being the guy who has to look under the rock to find this,” he said. "You guys are asleep at the switch”

@ICIJorg Adverse events data expert @DeviceEvents analyzed the devices most commonly cited in reports of autoimmune, allergic & toxicity symptoms - and found metal-on-metal hips #1, followed by metal and polymer hips, Essure, and metal, ceramic and polymer hips

@ICIJorg @DeviceEvents “I'm in a great deal of pain, so please bear with me,” said metal hip patient Sue Francis. “In order to protect patients, we need to recognize that these metals from day one are interacting with our bodies.”

@ICIJorg @DeviceEvents “Reactions such as sensitivity and allergic reaction to the materials that we use, that we’ve chosen, are important to us,” said Dr. Susan Alpert of industry group @AdvaMedUpdate. She emphasizes the millions of patients who benefit from metal implants

Today’s second most historic federal hearing comes to a close for the night. Stay tuned to this space for @ICIJorg’s story on the hearing. #ImplantFiles

@ICIJorg And here's our story!
icij.org/investigations…
Thoughts are welcome and let me know if there are any other issues we should be covering #ImplantFiles