Thread by @sashachavkin

When we published the #ImplantFiles, regulators around the world made big promises to reform medical device safety. Three months later, we rounded up who has taken action and who fell short on their promises...
icij.org/investigations…

Team Canada is out in front. Sparked by powerful reporting by @CBC @TorontoStar @RadioCanadaInfo, Health Canada announced an action plan that will strengthen evidence requirements for approvals, a new online database of adverse events, and more
thestar.com/news/investiga…

Other countries have taken substantial but incomplete first steps. The Netherlands, for example, made many promises that won't be enacted until 2020. A task force in India met to discuss medical device oversight for the first time
indianexpress.com/article/india/…

The biggest disconnect between rhetoric and reality may be in the US. FDA Commissioner @SGottliebFDA promised major reforms (see below), but experts say his proposals were either small tweaks or programs already underway and still languishing

https://twitter.com/sgottliebfda/status/1067044151022227462

The most concrete #ImplantFiles response has been a wave of regulatory activity on breast implants. Allergan textured implants have taken off European & Brazilian markets, and Allergan's global breast implant sales declined 74 percent in Q4 2018
icij.org/investigations…

Canada and the US are still investigating breast implant safety, and the FDA will hold a public hearing on breast implant safety in late March. ICIJ will be there
fda.gov/AdvisoryCommit…

Governments including Germany and the UK are also moving to create national registries of medical devices. But key questions - including whether they are public, reporting is mandatory, and what health problems are tracked - are not yet clear
icij.org/investigations…

But many patients feel that they are still at risk & their voices aren’t being heard. Women-led groups in particular have stepped up to demand regulators take action
icij.org/blog/2018/12/i…

Device industry groups have also expressed concern, saying our stories are missing the big picture. @AdvaMedUpdate says - correctly - that medical devices improve or save lives in the large majority of cases
advamed.org/newsroom/press…

The question - for me at least - is whether the system is working. Is it allowing preventable harm? Is patient safety ever taking a back seat to other priorities?
As long as those still happen - and reform promises remain unfinished - we will be keeping watch!