December 21, 2018

Response from Essure Problems Administrators to the Statement on Essure from FDA Commissioner Scott Gottlieb, M.D.

Response from Essure Problems Administrators to the statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s new steps to strengthen the long-term safety oversight of the Essure device following…
December 18, 2018

A Year-End Review of Medical Device Safety Movement Victories

Counting down to the end of 2018, we wanted to highlight some wins and accomplishments the medical device safety movement achieved this year. Essure’s removal from the market Medical device…
November 27, 2018

The FDA’s “Overhaul” of the 510(k) Process

It’s gratifying that four months after “The Bleeding Edge” exposed the flawed U.S. medical device approval process the FDA has announced regulatory changes to rely on more modern predicate devices…
November 1, 2018

How to Research a Device, by Medical Device Problems

Repost from Medical Device Problems  by Amanda Dykeman Head Research Coordinator and Administrator of Essure Problems/Vice President of ASHES Nonprofit Find out the specific name of your device Before beginning your research,…
October 24, 2018

What You Need To Know About Johnson & Johnson

This month, a British Medical Journal investigation revealed that Ulm Ulmsted, the inventor of the vaginal mesh implant, was paid $1 million by Johnson & Johnson to manipulate his data…
October 16, 2018

How To Find Out if Your Doctor Has Accepted Payments from Medical Device Companies

  It is legal for drug and device companies to make payments to doctors, though patients and industry professionals have raised questions about the ethics of these payments, and how…
October 2, 2018

Facing the Mesh Crisis – Sling The Mesh Guest Post

Kath Sansom of the United Kingdom launched Sling The Mesh as a support group for women suffering pelvic mesh pain and complications. It began with 20 women in 2015 and…
September 25, 2018

The Bleeding Edge Hero of the Week: Helen Haskell

  Helen Haskell is a cornerstone of the patient safety movement. Following the death of her son due to a medical error, Haskell became a leading voice in the campaign…
September 18, 2018

The Bleeding Edge Hero of the Week: Lisa McGiffert

"It would be great if the regulators of hospitals and doctors were more diligent about responding to harm to patients, but they’re not, so people have turned to other people...This…
September 11, 2018

The Bleeding Edge Hero of the Week: Dr. Rita Redberg

"Just because you have a new technology doesn't mean it's innovation. Too often I hear people say, 'Oh, you're going to stifle innovation.' They're not talking about stifling innovation; they're…
September 4, 2018

The Bleeding Edge Hero of the Week: Dr. Marty Makary

"We attract good people in healthcare, but there's this tremendous hunger to have the latest gadgets, the newest technology, without the proper evaluation of that technology. So we shouldn't be…
August 28, 2018

The Bleeding Edge Hero of the Week: Dr. David Kessler

"’Regulation is bad. Let's cut regulations. For every regulation we're going to cut umpteen regulations.’ That bravado may apply to certain fields, but it can't and shouldn't apply when you're…
August 21, 2018

The Bleeding Edge Hero of the Week: Madris Tomes

“We assume the FDA has the data that they need to crack down on manufacturers that have bad devices, or to recall a product, and they don't have that...Devices can be…
August 14, 2018

The Bleeding Edge Hero of the Week: Jeanne Lenzer

“The FDA is supposed to protect the public interest. Unfortunately, their behavior shows that they have been captured by industry." —Jeanne Lenzer Jeanne Lenzer is a renowned award-winning medical investigative journalist…
August 7, 2018

The Bleeding Edge Hero of the Week: Michael Carome

“Most people probably believe when they get a medical device implanted--be it a pacemaker or a joint--that those medical devices have undergone appropriate testing to demonstrate that they are safe and…
August 2, 2018

Patient safety before corporate greed: Breast Implant Victim Advocacy’s story

Jamee Cook, Chandra DeAlessandro, and Raylene Hollrah are co-founders of the Breast Implant Victim Advocacy group. The group was formed from their personal experiences and frustrations with breast implants, and…
Tammy Jackson Uncategorized
July 31, 2018

The Bleeding Edge Hero of the Week: Tammy Jackson

“I've been told that I need to be quiet sometimes. They can take my sex life, they can take my job, they can take my farm, but they're not going…
July 30, 2018

The Facts in The Bleeding Edge

The medical device industry has responded to the malfeasance exposed in our investigative documentary The Bleeding Edge. Here are the facts: The facts set forth in The Bleeding Edge are…
Diana Zuckerman Uncategorized
July 23, 2018

The Bleeding Edge Hero of the Week: Diana Zuckerman

“About 95% or more of have not been required to be proven safe or effective in clinical trials…. Whether it’s a hip implant, or a breast implant, or certainly a…
July 20, 2018

Victory! Bayer pulls Essure from the U.S. market

Breaking news — Seven long years after the E-Sisters began their fight against Essure, Bayer has now withdrawn the device from the US market! This victory comes one week before…
Jennifer Nelson Uncategorized
July 19, 2018

Our Lives Are a Gift: Jennifer Nelson’s Story

Jennifer Nelson is a member of Unplug the Robot, an awareness group for those harmed by da Vinci robotic surgery and those considering the surgery. In the founding member's own…
patient safety Uncategorized
July 17, 2018

The Bleeding Edge Hero of the Week: The E-Sisters

“We won't stop. They've already taken away my health. What else can they take from me? I have nothing to fear from them. This has to come to an end.…
July 16, 2018

The More You Know, The Less You Trust Bayer

Bayer has misled women around the world into believing their implantable birth control device Essure is safe and effective, resulting in pain and injury for tens of thousands, and for…
Frances Scott Uncategorized
June 26, 2018

These Hips Ruined Everything: Frances Scott’s Story

Frances Scott was at the height of her career when, at the age of 39, she had both hips surgically removed and replaced with two metal-on-metal Pinnacle model hips, made…
April 16, 2018

E-Sisters Update

Leaders of Essure Problems group met with FDA commissioner Scott Gottlieb in late February 2018. As a result, on April 9th, 2018, the FDA finally issued an order restricting the…