Discover and read the best of Twitter Threads about #ImplantFiles
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1/ Today, ICIJ unveils a bold new brand, mission and vision to expand our global reporting collaborations and renew our commitment to telling stories that show how the world really works — triggering positive change in tumultuous times. 🧵bit.ly/3bLEVI8
2/ With democracy & press freedom under attack globally, authoritarianism & inequality on the rise, and corporations increasingly operating beyond the realms of accountability, wealth & influence have accumulated in the hands of a powerful elite – secretly hoarded out of reach.
3/ ICIJ has directed the largest cross-border reporting initiatives in history, convincing reporters across the globe to set aside traditional rivalries to uncover corruption, abuses of power and grave harms inflicted on the world's most vulnerable people. 
New #ImplantFiles:
As the FDA delays, breast implant safety advocates are promoting informed consent laws in at least six states that would mandate warnings on health risks
icij.org/investigations…
As the FDA delays, breast implant safety advocates are promoting informed consent laws in at least six states that would mandate warnings on health risks
icij.org/investigations…
In Arizona, a law that requires plastic surgeons to warn patients about BIA-ALCL and breast implant illness has unanimously passed the State Senate.
Doctors who fail to comply could face losing their license
documentcloud.org/documents/7041…
Doctors who fail to comply could face losing their license
documentcloud.org/documents/7041…
Advocates are acting after the FDA has delayed for almost a year in enacting a rule that would require a patient informed consent checklist and black box label warning across the country
"Women are in danger," they say
fda.gov/media/131885/d…
"Women are in danger," they say
fda.gov/media/131885/d…
New #ImplantFiles:
The makers of Essure systematically failed to report injury complaints to the FDA, allege plaintiffs in recently unsealed court documents
icij.org/investigations…
The makers of Essure systematically failed to report injury complaints to the FDA, allege plaintiffs in recently unsealed court documents
icij.org/investigations…
The documents include a statistical analysis by experts who reviewed more than 5k complaints, and conclude:
24% should have been reported to the FDA, but only 5.5% were actually reported
89% were noncompliant in some way with FDA rules
icij.org/investigations…
24% should have been reported to the FDA, but only 5.5% were actually reported
89% were noncompliant in some way with FDA rules
icij.org/investigations…
This is the clearest info yet about how systemic Essure underreporting was. It's a shocking conclusion - that more than 3 out of 4 reportable complaints were buried.
Bayer disputes the findings and said the analysis has basic flaws in its methodology.
Bayer disputes the findings and said the analysis has basic flaws in its methodology.
New from #ImplantFiles:
The FDA warns Allergan for failing to properly carry out breast implant safety studies, including for products that have been globally recalled due to cancer risks
icij.org/investigations…
The FDA warns Allergan for failing to properly carry out breast implant safety studies, including for products that have been globally recalled due to cancer risks
icij.org/investigations…
The FDA promised to "hold manufacturers accountable if they fail to fulfill their obligations.”
But as @NC4HR's Diana Zuckerman points out, they've issued these warnings before but haven't taken tougher action - like removing products from the market - over flawed safety studies
But as @NC4HR's Diana Zuckerman points out, they've issued these warnings before but haven't taken tougher action - like removing products from the market - over flawed safety studies
The cycle of warnings and little change is largely why the breast implant safety struggle has been going on for over 30 years now... as this powerful video by @shirafu shows
New: We rounded up the unproven and sometimes dangerous COVID-19 treatments being disseminated around the world.
“We’re in the Wild West in terms of the public susceptibility to unsafe, unproven drugs or tests," @LawrenceGostin told us
icij.org/blog/2020/05/i…
“We’re in the Wild West in terms of the public susceptibility to unsafe, unproven drugs or tests," @LawrenceGostin told us
icij.org/blog/2020/05/i…
The story reinforced one of the biggest lessons from ICIJ's #ImplantFiles investigation:
However urgent the need, untested medicine places patients at risk and is ripe for abuse by industry and politicians
icij.org/investigations…
However urgent the need, untested medicine places patients at risk and is ripe for abuse by industry and politicians
icij.org/investigations…
We focused on a handful of examples, but more cases of untested COVID-19 treatments keep coming to light.
A new story by @saludconlupa found Peru just approved a costly arthritis drug by pharma giant Roche w/o clinical evidence that it works
saludconlupa.com/noticias/tocil…
A new story by @saludconlupa found Peru just approved a costly arthritis drug by pharma giant Roche w/o clinical evidence that it works
saludconlupa.com/noticias/tocil…
🚨Today we added 18 new members to our ICIJ family! 😀
Our network now spans 100 countries, with reporters from The Gambia, Luxembourg, Czech Republic, and more added today.
Here is a quick intro to these investigative reporters! (Thread) bit.ly/2vv0EyN
Our network now spans 100 countries, with reporters from The Gambia, Luxembourg, Czech Republic, and more added today.
Here is a quick intro to these investigative reporters! (Thread) bit.ly/2vv0EyN
🇲🇦 First up: Ali Amar, @MarocAmar, from @LeDesk in Morocco joins our family. He’s worked with us on #ImplantFiles, #PanamaPapers and #ParadisePapers.
Here's his work on the #PanamaPapers: ledesk.ma/2016/04/03/pan…
Welcome to the team!!
Here's his work on the #PanamaPapers: ledesk.ma/2016/04/03/pan…
Welcome to the team!!
@MarocAmar @LeDesk 🇨🇱 @aarellanoj joins us from #Chile – where he’s been working for @ciper as a reporter/editor, now contributor, for six years.
He also worked on #PanamaPapers and #ParadisePapers with us!
He also worked on #PanamaPapers and #ParadisePapers with us!
Major #ImplantFiles update: 20 new countries and 15,000 records added to ICIJ's International Medical Devices Database. Here's why that's a big deal...
icij.org/blog/2019/11/s…
icij.org/blog/2019/11/s…
Prior to #ImplantFiles, there was no 1 place to see medical device safety data across borders. This data gap meant device-related tragedies often repeated in country after country, & its one of the big reasons we did the project in the first place
icij.org/investigations…
icij.org/investigations…
ICIJ's data team has done the painstaking work of putting together device recall and safety alerts from 46 countries around the world. Here is the final result: a unique and essential resource for patients, doctor and regulators everywhere
medicaldevices.icij.org
medicaldevices.icij.org
Today, we're adding an extra 15,000 safety reports from 20 new countries to our International Medical Device Database. Our database now covers 46 countries and comes one year after we, alongside 58 media partners, first published #ImplantFiles. bit.ly/37yx762
We're publishing the data in a bid to bring more #transparency to the medical device industry.
We hope it will become a resource for patients who, in many parts of the world, don’t otherwise have access to these types of reports. #ImplantFiles
We hope it will become a resource for patients who, in many parts of the world, don’t otherwise have access to these types of reports. #ImplantFiles
No se pierdan la actualización en español de nuestros partners de @elconfidencial: bit.ly/34lKEMf #ImplantFiles
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.
We've updated our story on today's major #ImplantFiles news of Allergan's global recall of Biocell implants. Here are few important points we added after hearing from the FDA & other experts (thread)...
icij.org/investigations…
icij.org/investigations…
A key factor in FDA's decision was a recent surge of BIA-ALCL death reports, from 9 deaths in February to 33 today. Almost 2/3 of the 33 deaths were outside the US. In other words, an influx of new reports from outside US (not clear where) was crucial
fda.gov/medical-device…
fda.gov/medical-device…
Plastic surgeon and BIA-ALCL expert @saferimplants says the FDA decision reflects improved BIA-ALCL data and an evidence-based decision process. “What we’re seeing is the first sign that data and evidence is driving regulatory decision-making,” he said
icij.org/investigations…
icij.org/investigations…
Allergan's global recall of Biocell textured implants came after the FDA requested that it remove them from the market after finding recent surge in cases of BIA-ALCL, according to the FDA. Allergan described the recall as voluntary in its press release
finance.yahoo.com/news/allergan-…
finance.yahoo.com/news/allergan-…
"Of the 573 unique cases of BIA-ALCL, 481 are attributed to Allergan implants. Of the 33 patient deaths the FDA is reporting today, 12 of the 13 patients for which the manufacturer of the implant is known" had Allergan implants - FDA's not-yet-public statement #ImplantFiles
And here's the FDA statement
fda.gov/news-events/pr…
fda.gov/news-events/pr…
Today is the last day of @SGottliebFDA's very eventful two year tenure as FDA Commissioner. We've covered the FDA closely during that time for the #ImplantFiles, and I had a few thoughts on his departure...
nytimes.com/2019/04/04/hea…
nytimes.com/2019/04/04/hea…
For one thing, I was very glad to cover an agency that responded to investigative journalism by trying to fix the problems, rather than lashing out at the media. That kept the focus where it belongs - on the public interest & patient health and safety
There were also real shortcomings: Gottlieb promoted a rosy view of a deeply flawed medical device oversight system, sometimes touted reforms that were more spin than substance, and embraced a device industry agenda that wasn't always best for patients
Canada and the Netherlands suspend sales of breast implants linked to cancer risk. Growing impact from #ImplantFiles as the ban announced by France this week sets off a chain reaction in regulators across continents
icij.org/investigations…
icij.org/investigations…
Here are more details on Canada's decision, via @thecribby @jesse_mclean. Health Canada gives Allergan 15 days to provide more evidence, after which it will remove Biocell implants from the market unless it is satisfied
thestar.com/news/investiga…
thestar.com/news/investiga…
We've made a correction to this story, now reflected in the text: the Dutch did not officially suspend sales of macrotextured & polyurethane implants, the Dutch Plastic Surgery Association voluntarily suspended them at the request of the Dutch health minister
Latest from the #ImplantFiles - The FDA says it will disclose information on millions of medical device complications buried for nearly two decades under "alternative summary reporting." Big win for patients & transparency
icij.org/investigations…
icij.org/investigations…
There are also some limitations. The FDA will disclose past and future summary reports, which condense large numbers of incidents into one submission. That's not the same as individual reports of each incident. We're looking into the details & will share as we know more
The FDA also didn't provide a timetable for when the reports will be disclosed. Some past FDA promises (see below) didn't pan out as described. That said, Gottlieb's language was pretty explicit that they're "making ALL of this data available"
Our latest #ImplantFiles story reveals that the FDA kept hundreds of thousands of breast implant incident reports out of public sight. It also raises some pretty basic questions about a major FDA program called alternative summary reporting (thread)
icij.org/investigations…
icij.org/investigations…
Alternative summary reporting is a program that lets medical device makers report many adverse events in non-public quarterly summaries. At least 1.1 million incidents were kept from public view by ASR since 2016, @By_CJewett revealed this month
khn.org/news/hidden-fd…
khn.org/news/hidden-fd…
The FDA & device industry give two main defenses for ASR: that it reduces the burden of medical device reporting, and the types of incidents it covers are common, non-lethal problems that the agency already knows about
Today’s FDA hearing on breast implant safety is underway. I’ll be covering it live for @ICIJorg
Today's hearing will address the rare cancer BIA ALCL that is associated with breast implants, as well as the autoimmune/inflammatory symptoms known as breast implant illness. Regulators, doctors, patients and industry will all testify.
Dr. Binita Ashar, director of Surgical Devices at FDA's device division, kicks off. She notes backdrop of recent actions on BI safety by FDA, European Union and Canada. On BIA ALCL, says % of ALCL among smooth vs textured implant patients unknown, so both groups should be advised
The FDA posts meeting materials for next week's hearing on breast implant safety. Among the questions the panel will consider are risk factors for BIA-ALCL, risk profile of textured implants and how to address breast implant illness symptoms #ImplantFiles
The panel is a group of FDA-selected experts who will then make recommendations after the hearing. These recs often guide policy but the FDA is not required to follow them
The full meeting materials, including a detailed agenda & FDA summary of the evidence, are here. I will be covering the hearings live on Twitter and also at icij.org - send me any questions, thoughts or info that we should consider!
fda.gov/AdvisoryCommit…
fda.gov/AdvisoryCommit…
The FDA says it will investigate adverse patient reactions to silicone in breast implants, nickel in Essure, and other materials in medical devices. Significant new response to key issues in #ImplantFiles
icij.org/investigations…
icij.org/investigations…
Perhaps most striking is the change in the FDA's tone on breast implant illness, which just a few months ago it strongly suggested did not exist. Now it says it needs more info to communicate risk and minimize harm
fda.gov/NewsEvents/New…
fda.gov/NewsEvents/New…
This from the FDA stands out in particular: "We believe the current evidence, although limited, suggests some individuals may be predisposed to develop an immune/inflammatory reaction when exposed to select materials."
icij.org/investigations…
icij.org/investigations…
#ImplantFiles update: I missed this yesterday... CR Bard, one of the biggest manufacturers of vaginal mesh, is "voluntarily removing" mesh products, including Avaulta & Align, from European markets (h/t @MeshCampaign) 1/6
assets.publishing.service.gov.uk/media/5c7fef30…
assets.publishing.service.gov.uk/media/5c7fef30…
In its statement, Bard (now part of @BDandCo) refers to a “product removal”. Says it's “initiating a cease in production & distribution …with immediate effect”. Does not use the word “recall”. 👇
Also says “This product removal has not resulted from any safety concerns” 2/6
Also says “This product removal has not resulted from any safety concerns” 2/6
Bard removed Avaulta mesh products from the U.S. market in 2012 after the FDA ordered the company, and other mesh manufacturers, to conduct additional clinical studies (see extract from @WSJ report from the time 👇). In 2016, Align was withdrawn in the U.S. 3/6
This number is staggering: more than 1.1 million incidents of medical device related injuries and malfunctions since 2016 have been kept hidden from public view in the FDA's "alternative summary reporting" database. Powerful investigation by @By_CJewett
khn.org/news/hidden-fd…
khn.org/news/hidden-fd…
“I don’t want to sound overdramatic here, but it seemed like a cover-up," said one doctor whose surgical device malfunction was nowhere to found in public records
Alternative summary reporting is one of 3 key ways - along w manufacturers' failure to report incidents, and misclassifying deaths and injuries as less severe problems - that harm caused by medical devices gets concealed, we found in #ImplantFiles
icij.org/investigations…
icij.org/investigations…
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…
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…
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/…
indianexpress.com/article/india/…
Today’s FDA hearing on the safety of vaginal mesh is underway. I’m here covering the event for @ICIJorg
The hearing will include testimony from patients, doctors, industry reps, lawyers and more. It is considering the use of surgical mesh for repair of pelvic organ prolapse (POP) - there are three POP mesh products that remain on the US market
Hearing begins w statements from the public. First speaker is Kila Baldwin, attorney who won $41 million verdict against Johnson & Johnson. She says there is "no good sound evidence" supporting mesh safety & that it should be taken off the market
French health authorities just wrapped up their public hearing on textured breast implants and the rare cancer BIA ALCL. It was part of a week of significant news on breast implant safety oversight (thread)
icij.org/investigations… … #ImplantFiles
icij.org/investigations… … #ImplantFiles
This week, this U.S. Food and Drug Administration announced that more women had been diagnosed with BIA ALCL, bringing the total to at least 457 cases. Here's the story from our #ImplantFiles partner @LaurNBC
nbcnews.com/health/womens-…
nbcnews.com/health/womens-…
Perhaps most significantly, the FDA sent a letter to doctors across America warning of "an association between all breast implants, regardless of filling or texture" and ALCL. This could make a big difference in awareness - you can read the letter here
fda.gov/MedicalDevices…
fda.gov/MedicalDevices…
1 Thread critique d’une critique. Quand Karim Ibatazène dénonce le « faux scandale des dispositifs médicaux ». lacoupedhygie.fr/index.php/2018…
2 Karim Ibatazene, rédacteur du blog « la coupe d’Hygié » est pharmacien et ne se cache plus de travailler pour l’industrie pharmaceutique, depuis que Borée l’avait démasqué boree.eu/?p=3553
3 Il prétend néanmoins toujours proposer des opinions purement « techniques » et donc éthiquement, idéologiquement et scientifiquement neutres sur des sujets d’actualité ce que lui permettrait sa très grande expérience de ces questions auprès de Big Pharma.
