Essure Permanent Birth Control System by Bayer Healthcare: Announcement – (FDA Restricts) the Sale and Distribution


[Posted 04/09/2018]AUDIENCE: OBGYN, Patient, Risk ManagerISSUE: The FDA is aware that some women have received the Essure device without being adequately informed of Essure’s risks. In order for this device to meet reasonable assurance of safety and effectiveness, all women considering Essure should receive this important information.On April 9, 2018, the FDA restricted sales of the Essure device to only doctors and healthcare facilities who use the FDA-approved “Patient-Doctor Discussion Checklist – Acceptance of Risk and Informed Decision Acknowledgement”. Sale and distribution of Essure is limited to healthcare providers who agree to review this checklist with patients, and give them the opportunity to sign it, before Essure implantation. The FDA has approved this new safety measure to ensure that the device meets standards for a reasonable assurance of safety and effectiveness.

The FDA also approved Bayer’s new labeling that includes:

  • The following statement: “The sale and distribution of this device are restricted to users and/or user facilities that provide information to patients about the risks and benefits of this device in the form and manner specified in the approved labeling provided by Bayer.”
  • Bayer’s Patient-Doctor Discussion Checklist – Acceptance of Risk and Informed Decision Acknowledgement, which is part of the patient information booklet, and has key items about the device, its use, and safety and effectiveness outcomes, which the patient should be aware of as they consider permanent birth control options.

BACKGROUND: The FDA wants to ensure that each and every woman who receives Essure has been informed of the risks and benefits before getting the device implanted. The FDA has taken steps, including labeling changes in 2016 adding a boxed warning and patient decision checklist, to better inform health care providers and patients about the risks.

RECOMMENDATION: Health care providers should thoroughly discuss available sterilization and birth control methods with their patients, including their benefits and risks. The FDA-approved Decision Checklist based on the Final Guidance should be used to facilitate these discussions and ensure patients understand the benefits and risks.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[04/09/2018 – Essure Activities – FDA]
[04/09/2018 – Information for Health Care Providers – FDA]

Page Last Updated: 04/09/2018 

Jul 26, 2017 – But it is also the only class of device shielded from most lawsuits, thanks to a 2008 Supreme Court decision that makes it difficult for patients to sue in state court for devices that have received premarket approval. In addition, the FDA granted Essure expedited review, a legacy of AIDS activism intended to … wapo

Wells Fargo – Help Us Make Change at Wells Fargo


https://youtu.be/TYaJoErhF-g

Wells Fargo is America’s worst bank.

To avoid the fury of just about everyone, Wells Fargo moved their annual shareholder meeting this year to Des Moines, Iowa.

Well, they can run but they can’t hide. We’re urgently need your help to make this bigger.

Iowa is home to People’s Action member Iowa Citizens for Community Improvement. People’s Action and Iowa CCI will be inside (we bought shares and got proxies) and outside Wells Fargo’s shareholders meeting to fight for change.

We’re demanding that the Wells Fargo board of directors and CEO step down. They have overseen scandal after scandal. It’s time for new leadership and a new direction.

You can help us stop Wells Fargo from profiting off prisons, funding big oil and their pipelines, bankrolling the NRA and gun makers, predatory lending, tax dodging, defrauding customers and polluting our democracy.

Wells Fargo is the official bank of the NRA. After the horrific shootings in Newtown, Connecticut at Sandy Hook Elementary School, Wells Fargo doubled down on guns. Since 2012, Wells Fargo is the number one lender to the gun industry with $431.1 million in loans and bonds.

Wells Fargo’s financial products have hurt millions of people. No one is safe from their predatory scams. Not veterans, students, homeowners, or car owners. In the most recent scandal, Wells Fargo opened 3.5 million accounts in customers’ names without telling them.

Wells Fargo has financed $120 million of the Dakota Access Pipeline. Wells Fargo finances private prison giants GEO Group and Corrections Corporation of America.

 

Ryan retires … Indivisible Team


Dear Friends,

Paul Ryan (R, WI-1, “Boy Scout”, P90X enthusiast) is retiring. WE REPEAT, PAUL RYAN IS RETIRING.

And literally as we were writing this email, another Rep. Dennis Ross (R, FL-15) announced his retirement. Just last week, we endorsed Andrew Learned, a Democrat hoping to win the Florida primary in August and take on Ross (who whipped votes for TrumpCare) in November.

We can’t understate this: this news is HUGE.

When Republicans got to Washington on January 3, 2017, they were ready to use the orange one in the White House as a cover for their draconian agenda. But you showed up, week after week, month after month… you never let up. You put pressure on your members of Congress (MoCs) and Congressional leadership to let them know you weren’t going to stand for the repeal of the Affordable Care Act or the mass deportation of Dreamers and their families.

To put it simply: you stopped their agenda and had even the most powerful MoCs in Washington shaking in their boots.

And you kept it up by holding these MoCs accountable when they took bad votes. When the House passed the Tax Scam, Indivisibles held retirement parties to tell their MoCs say 👋👋👋 to their seats in November:

Ryan and Ross are now on the long list of dozens of House Republicans who decided to throw in the towel and retire, instead of face Democratic challengers (and you!) at the polls this November:

  • Trent Franks (AZ-8)
  • Darrell Issa (CA-49)
  • Dave Trott (MI-11)
  • Pat Tiberi (OH-12)
  • Ryan Costello (PA-6)
  • Tim Murphy (PA-18)
  • Lamar Smith (TX-21)
  • Bob Goodlatte (VA-6)
  • Dave Reichert (WA-8)
  • And dozens more!

In short, Ryan is only the latest and biggest rat to abandon the sinking ship. They all see what we see: the big blue wave is coming. Indivisibles in-district, on their home turf were relentless and creative and bold in their accountability, and inspired nationwide energy to force Republicans out of Congress.

  • Indivisible Roanoke showed up literally on day one to Goodlatte’s office to hold him accountable for trying to gut the Congressional Ethics Office.
  • The day before Issa retired, Indivisible groups in San Diego held a retirement party for him (oh, and they showed up 49 weeks in a row before that).
  • And when Costello retired, he said, “I think everybody is aware of what the environment is because they deal with Indivisible people outside their office every week protesting.”
  • Paul Ryan faced Indivisibles e-v-e-r-y-w-h-e-r-e he went, not just on his home turf.

Here’s the part where we ask you for money

The blue wave we all want in November won’t build itself, and we can’t wait until September or October to get to work. Indivisible groups are everywhere, and we want to support them with organizers on the ground. So we’re doing something big: we’re doubling the number of regional organizers we have on the ground to support, train, and electoralize our resistance.

Organizers are the front-line support team for local Indivisible groups: providing information, training, and help with coordination with other Indivisible groups and partner organizations. Here’s what doubling our organizing team will mean to Indivisibles on the ground:

  • We’ll put an organizer on the ground in the 10 most urgent states to flipping the House, Senate, and key governors’ races — Arizona, California, Colorado, Florida, Michigan, New York, Ohio, Pennsylvania, Tennessee, and Texas.
  • We’ll work with hundreds of Indivisible groups to recruit volunteers, register voters, and reach out to them every way we can — through canvassing, phone-banking, and peer-to-peer texting — to grow this movement and the blue wave coming on election day.
  • And for Indivisible groups who’ve endorsed candidates, we’ll provide support and strategic guidance from an organizer, voter contact tools, and also help identify and drive volunteers’ energy on these races, well before November.

There are now 43 House GOP members who’ve resigned in disgrace or announced they’re not running for re-election. In honor of Paul Ryan being number 43, would you consider throwing in $43 to support Indivisible’s election organizing plan?

The resistance is fueled by individuals taking action, and Indivisible is fueled by individual donations like yours. Paul Ryan has the Koch’s, and look at what that got him. We’ve got you, and we’re going to win. Throw in whatever you can — we’re building this wave together.

In solidarity,
The Indivisible Team

Delete Facebook? – hours to go!!! ~ Ricken Patel – Avaaz


Mark Zuckerberg testifies at the US senate and we’re running full-page ads of our open letter in major newspapers — share this everywhere to make the letter a million strong and make Zuckerberg commit to Fixing Facebook! 

Dear friends,

It’s official: Facebook and social media are out of control. A quarter of a BILLION Facebook accounts are fake! 87 million of us had our data stolen to help Trump win. Russian disinformation operations generated BILLIONS of shares. On Wednesday CEO Zuckerberg will make history testifying before the US Congress. This is our moment to force government and big internet to commit to fix this mess. Sign the open letter below with one click and Avaaz will deliver it in a massive action outside Congress:

 

To Mark Zuckerberg, Internet CEOs and Government Regulators:

Enough is enough. We call on you to protect our democracies and immediately:

  • Tell the Truth about fake users and disinformation campaigns, including through independent audits.
  • Ban the Bots – ban ALL fake or imposter user accounts.
  • Alert the Public – notify all users EACH time they are exposed to fake or malicious content, and correct the record.
  • Fund the Fact-Checkers – an independent army big enough and fast enough to stem the spread of lies.

Crucial elections are just months away. Facebook’s motto used to be Move Fast and Break Things. Now you need to Move Fast and Fix Things.

Sincerely,

 

ADD MY NAME

It’s not an exaggeration. Everything we love is under threat – from human rights to democracy to the environment.

This problem is worldwide, with the UN even blaming Facebook for genocide of the Rohingya! But Russia has weaponised it, launching what NATO calls the biggest information war in history. They’ve set up millions of fake users, pages, sites, organisations posing as everything from neo-Nazis to leftist muslim-rights organisations to psychic fortune tellers — all designed to promote the far right, infiltrate the left, and undermine democracy. They’ve generated billions of shares, reaching virtually all of us.

Facebook says they’re acting fast, but they’ve dragged their feet for months, and they won’t be transparent. Their answer is “trust us”. We can’t afford that anymore, so this Wednesday let’s make sure we get the ball rolling with US legislators and Zuckerberg publicly committing to our call to action — add your name with one click:

ADD MY NAME

In many ways, the Russian and far-right disinformation campaigns are the mirror image of our movement. In response to our real movement building global unity, they launch fake movements, pushing lies and deception to divide us. As a result, they’ve seen us as a powerful opponent and constantly targeted Avaaz! This is a battle for the soul of the internet, for democracy itself, for our future. Let’s win it.With hope and determination,

Ricken, Christoph, Nell, Mia, Alaphia, Diego, Fadi, Marie, Jenny, Meetali, Andrew, Nick, Fatima, Danny and the whole Avaaz team.

MORE INFORMATION:

Inside the two years that shook Facebook – and the world (Wired)
https://www.wired.com/story/inside-facebook-mark-zuckerberg-2-years-of-hell/

Facebook Says Data on Most of Its 2 Billion Users Is Vulnerable
https://www.bloomberg.com/news/articles/2018-04-04/facebook-says-data-on-87-million-people-may-have-been-shared

Germany starts enforcing hate speech law (BBC News)
http://www.bbc.com/news/technology-42510868

How Facebook can cut down on fake news without relying on thousands of humans to decide what is true (Quartz)
https://qz.com/836508/facebook-nasdaqfb-can-stop-spreading-fake-news-without-becoming-an-arbiter-of-truth/

Selective Exposure to Misinformation: Evidence from the consumption of fake news during the 2016 U.S. presidential campaign (Princeton University, Dartmouth College, University of Exeter)
http://www.dartmouth.edu/~nyhan/fake-news-2016.pdf

What’s Even Worse Than Pruitt’s Scandals? – Sierra Club Insider


Insider

Time to Fire the Fireman

“Like the fireman in Ray Bradbury’s dystopian classic Fahrenheit 451, whose job is to burn books rather than save them, EPA Administrator Scott Pruitt has perverted the Environmental Protection Agency’s mission with a radical agenda to undermine not only the agency itself but also more than half a century of bipartisan environmental progress in this country.” So writes Sierra Club executive director Michael Brune at the end of a week when Pruitt was becoming enmeshed in an ever-mounting series of scandals.

Read more about why Pruitt is unfit to lead the EPA, and sign our petition telling him it’s time to resign. Million-Plus Turn Out to March for Our Lives -- Read more

 


Pompeo the Wrong Choice for Secretary of State

As climate change increasingly influences our international relations, CIA director Mike Pompeo is the wrong choice for Secretary of State. As a U.S. Represenative, he ignored the scientific consensus around climate change and was a top recipient of Koch Brothers money. In his CIA confirmation hearings, he refused to answer questions relating to climate change. As Secretary of State, Pompeo would play a critical role in evaluating dirty fuel projects proposed by the oil and gas industry to which he owes his success.

Tell your senators to vote against confirming Mike Pompeo as Secretary of State. Protect Pollution Safeguards of Tribal and Public Lands -- Read more

 


What Are Your Earth Day Plans?

On April 22, Team Sierra will be raising money via our 2nd Annual Nationwide Earth Day Hike. Adam Kerns of Frederick, Maryland, is hiking because he’s concerned about the health of the Chesapeake Bay. Stephanie Goering of Madison, Virginia, who became a committed activist after participating in last year’s Climate March in D.C., is hosting a 5K run. Ariana Kaiser Varnum of Los Angeles decided to organize an Earth Day outing after being awed by what she saw during a field trip to the Audubon Canyon Ranch in Northern California.

Read about why these three and others have joined this year’s Earth Day hike…and sign up!

Photo of Adam Kerns with his husband Matt Wright. School of Awe -- Read more

 


Explore
Whitewater Adventures
Looking for wild ride? Raft challenging rapids, hike to expansive views, or explore ancient rock art on a classic Sierra Club raft trip in Alaska and the Lower 48. We’ve got family raft trips, too! 

See all of our raft trips and sign up.Photo by Alacatr/iStock International Journeys -- Read more


Native Activists Halt New Drilling Near Chaco Canyon

As recently as 2003, the Bureau of Land Management said that oil and gas drilling in the greater Chaco Canyon area was not “economically viable or technologically feasible.” It became so with horizontal drilling. The Trump administration tried to lease nearly 4,500 acres in the greater Chaco area—then they ran into the power and spirit of tribal activists.

Find out more about Chaco and how Native American activists put a stop to the Trump administration’s tone-deaf lease sale.

Photo by Avid H. Collier/Getty Public Lands for Whom? -- Read more

 


Get the Latest From Sierra Magazine

Looking for an easy way to get a daily dose of environmental inspiration? Sign up for The Green Life email and get the latest from Sierra magazine—everything from news articles to sustainable living tips to outdoor adventure stories, sent every weekday to your Inbox.

Sign up. Public Lands for Whom? -- Read more

 


Sierra Club + Earth Day = Great Gear

Shop the Sierra Club Store: Celebrate Earth Day every day with our gardening kit, which includes a bag, gloves, seed packets, trowel, stainless steel water bottle, and more. Toss some extra seed packets into your cart—everything is 20% off through April 22!

Use code EARTHDAY on checkout.

Shop today! Public Lands for Whom? -- Read more

 


Enjoy
The Phases of Venus
The “evening star” is the brightest of all the planets because of its proximity to Earth and its perpetual, reflective cloud cover. In April, the planet is relatively far from the sun, making it shine even more brightly from our earthly point of view, and giving it a nearly full (gibbous) shape. Insomniacs can watch Saturn and Mars rise during the wee hours early in the month (use binoculars to glimpse Saturn’s rings and the white polar region on Mars), and other heavenly highlights include the Lyrid meteor shower, which peaks on… 

Click here to find outFiction to Inspire a Better Future -- Read more


Tabasco In Hot Water? -- Read more

Wolves in the Crosshairs

In Wyoming, wolf hunting is now legit 365 days a year across 85 percent of the state, where wolves are classified as “shoot-on-sight vermin.” The remaining 15 percent, concentrated around Jackson Hole and the Tetons, is a “trophy area” where wolves can still be seasonally hunted. Today anyone in most of Wyoming can kill wolves without a hunting license, and almost any form of violence—guns, snares, explosives, hunting from vehicles and snowmobiles—is allowed. Between the first legal hunt in five years and the unlicensed slaughter, Wyoming may have lost a quarter of all its wolves last year.

How did this happen?


And Now This…

From coast to coast, the movement for 100 percent clean and renewable energy is growing fast. More than 60 cities and towns across the U.S. have already committed to 100 percent clean energy as part of the Sierra Club’s Ready for 100 campaign, a movement of students, businesses, faith leaders, elected officials, and community members who are working to move us away from fossil fuels.

Check out what Ready for 100 director Jodie Van Horn has to say in this new video, and help spread the word by sharing. The Pacific Crest Trail in the Era of Climate Change -- Read more

 


Pruitt, Automakers Conspire to Loosen Fuel-Economy Rules

At the New York Auto Show in Manhattan last month, automakers preened and trumpeted their latest electric, hybrid, and plug-in models, while the Alliance of Automobile Manufacturers, the industry’s primary trade group, launched a million-dollar ad campaign about how electric vehicles “drive change.” Meanwhile, 250 miles down I-95 in Washington, D.C., auto industry execs were working behind the scenes with EPA administrator Scott Pruitt to spread misinformation about the science of human-driven climate change and roll back Obama-era rules to increase fuel efficiency.

Read about Pruitt’s latest attack on the environment, this time through tailpipe emissions. Surprising Ways to Talk About Climate Change -- Read more