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


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