ICIJ – Breast Implant Injuries Kept Hidden As New Health Threats Surface

November 26, 2018 – INTERNATIONAL CONSORTIUM OF INVESTIGATIVE JOURNALISTS (ICIJ) – Manufacturers fought to get implants back on the market. Regulators gave in. Now thousands of patients are paying the price.

More than 10 million women worldwide have received breast implants over the last decade, a remarkable comeback for a medical product that had suffered a crippling safety scandal and a lengthy ban in the United States.

The U.S. Food and Drug Administration’s decision to restore silicone implants to the market in 2006 followed an earlier decision to approve the less-commonly-used saline-filled implants. It came after a furious lobbying campaign by leading manufacturers Allergan and Mentor, which convinced regulators that frequent ruptures and leaks, and an array of other ailments reported by breast implant patients, were concerns of the past.

But many of the hazards that caused breast implants to be banned in the first place never went away, a global investigation led by the International Consortium of Investigative Journalists has found.

A growing body of scientific literature links breast implants to autoimmune disorders and a rare form of cancer that has claimed more than a dozen lives worldwide.

Madris Tomes, founder and chief executive of Device Events, was one of the many contributors to this article.

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ICIJ – IMPLANT FILES – Frequently Asked Questions & Resources

November 25, 2018 – INTERNATIONAL CONSORTIUM OF INVESTIGATIVE JOURNALISTS (ICIJ) – The Implant Files is a globe-spanning investigation revealing a broken system that allows flawed medical devices to go onto the market — and into our bodies.  Involving more than 250 reporters in 36 countries, ICIJ reporters and partners with hundreds of patients about the system’s pitfalls. There are countless medical implant success stories to celebrate. But the public is often the last to know about potentially dangerous malfunctions tied to implants.

Madris Tomes, founder and chief executive of Device Events, was one of the many contributors to this article.

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FDA to speed up review of medical products for U.S. military

November 2, 2018 – Medical Design & Outsourcing – The U.S. FDA today announced a memorandum of understanding with the Department of Defense to accelerate regulatory assessment of medical products for military personnel.

Congress last year passed a law to expedite regulatory review of products to diagnose, treat or prevent serious diseases or conditions facing U.S. military personnel. The memorandum establishes a framework to implement the 2017 law. It allows the Secretary of Defense to request that FDA speed up the review of investigational submissions, applications for approval/licensure, and submissions for clearance for particular medical products.

The increased collaboration between FDA and the military may actually prove to be good news for medical device safety, according to Madris Tomes, a former FDA analyst who is founder and CEO of medical device safety information software company Device Events.

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Bayer Will Stop Selling the Troubled Essure Birth Control Implants

July 20, 2018 – New York Times – Bayer announced on Friday that it would discontinue sales of its Essure birth control implant by the end of the year, bowing to a lengthy campaign by health advocates and thousands of women to get the device off the market.

The implant has had a troubled history. It has been the subject of an estimated 16,000 lawsuits or claims filed by women who reported severe injuries, including perforation of the uterus and the fallopian tubes. Several deaths, including of a few infants, have also been attributed to the device or to complications from it.

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Madris Tomes, a former F.D.A. medical device official who runs a company that analyzes adverse event data, puts the figure closer to 30,000.

“With side effects ranging from hair loss and tooth loss to chronic pain, severe bleeding, miscarriages and even death, the benefit risk profile touted by Bayer simply didn’t jibe with the data that was pouring into the F.D.A. from both patients and physicians,” said Ms. Tomes, who has done pro bono work for an Essure patient advocacy group.

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FDA tightens restrictions on Essure birth control device

April 9, 2018 – CNN – By Jessica Ravitz – FDA tightens restrictions on Essure birth control device – Since it was approved to go on the market in 2002, Essure, an implantable permanent contraceptive device, has been plagued by controversy. Thousands of women have filed grievances with the US Food and Drug Administration about unintended pregnancies, miscarriages, stillbirths, severe pain and bleeding.

In its latest response to ongoing concerns, the FDA issued an order Monday to restrict sales and distribution of the device.

“We’ve been closely evaluating new information on the use of Essure, and based on our review of a growing body of evidence, we believe this product requires additional, meaningful safeguards to ensure women are able to make informed decisions about risk when considering this option,” FDA Commissioner Dr. Scott Gottlieb said in a written statement.

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Madris Tomes is keynote speaker at York County Women’s Business Center Organization Meeting

February 13, 2018 – York County – Women’s Business Center Organization Meeting: More than 100 people attended a York County Women’s Business Center Organization (WBCO) Luncheon, where Madris Tomes, Founder & CEO of Device Events and winner of the 2017 Rise of the Rest pitch competition, shared her story as an female entrepreneur. After her keynote presentation, Ms Tomes was surprised to also receive a Proclamation on behalf of the County of York PA. The Proclamation was presented by York County Commissioner Chris Reilly.

Read The York County Proclamation…

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Opening Yourself Up For Trouble: The Untested World Of Medical Devices

January 10, 2018 – Think with Kyrs Boyd – Health  Podcast – One of every 10 Americans is walking around with a pacemaker, artificial knee or some other medical device implanted inside them. And the owners of these pieces of equipment might be horrified to know that they underwent little – if any – clinical trials before being inserted into their new owners. Jeanne Lenzer joins us to talk about the lack of oversight in the industry, which she writes about in “The Danger Within Us: America’s Untested, Unregulated Medical Device Industry and One Man’s Battle to Survive It” (Little, Brown and Company)

Madris Tomes and Device Events is mentioned at 46:37 of the podcast.

Listen to Podcast…

Steve Case announces ‘Rise of the Rest Seed Fund’ to help more startups like Device Events.

Forbes – December 5, 2017A Bevy Of Billionaires Join Steve Case’s $150 Million ‘Rise Of The Rest’ Startup Fund

Steve Case’s Rise of the Rest campaign to promote entrepreneurship outside of Silicon Valley is getting its own fund.

Called the Rise of the Rest Seed Fund, the fund announced on Tuesday will invest $150 million in startups outside of tech’s usual stomping grounds and with the support of a group of three-dozen of America’s best-known business leaders including Jeff Bezos, Sara Blakely, and Howard Schultz.

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WEBINAR Scheduled for Noon EST, November 5, 2017

Medical Device Adverse Events – Reports, Trends & Email Notifications | Never Use FDA MAUDE Again!

When: Wednesday, November 15, 2017 – Noon EST

This webinar will demonstrate how Device Events can be used by healthcare organizations to quickly and affordably identify, analyze and track, the health risks associated with specific medical devices before recalls are announced.

Attendees will see how the system can enable them to:
• Improve health outcomes and patient safety
• Inform procurement
• Reduce risks for their organizations

Click Here to Register