Research Letter – Miscategorization of Deaths in the US Food and Drug Administration Adverse Events Database

October 7, 2019 – JAMA Internal Medical – Research Letter 

Authors: Lily Meier; Elizabeth Y. Wang, BA; Madris Tomes, MBA; Rita F. Redberg, MD, MSc

As the US Food and Drug Administration (FDA) moves to hasten approval of medical devices, data from postmarketing studies and registries are increasingly relied on to inform decision-making. With less time for premarketing clinical studies, postmarketing data are the principal way adverse events and risks become apparent. Even for high-risk implanted devices, premarketing trials are usually small and have short-term follow-up.1 The process of reporting adverse events is cumbersome, and reporting rates are low.2

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FDA releases millions of records of incidents involving medical devices

June 21, 2019 – Star Tribune – The U.S. Food and Drug Administration on Friday published millions of previously undisclosed reports of problems and post-surgical complications involving medical devices, including reports on implantable cardiac defibrillators, pacemaker electrodes and dental implants.

The roughly 6 million reports released Friday cover a wide array of devices in reports that were secretly filed with the FDA from 1999 to April of this year. From Allergan to Zimmer, dozens of medical device makers have filed reports on everything from breast implants and heart monitors to pediatric breathing machines. Device makers with Minnesota ties in the data include Boston Scientific, Coloplast, Medtronic and the former St. Jude Medical.

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FDA bans sales of transvaginal mesh amid safety concerns

April 16, 2019 –  (CNN) – Manufacturers of surgical mesh products must stop selling and distributing their products in the United States immediately, the US Food and Drug Administration ordered Tuesday.

The FDA said it “has determined that the manufacturers, Boston Scientific and Coloplast, have not demonstrated a reasonable assurance of safety and effectiveness for these devices.”

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[Documentary] Breast Implants THE TROUBLE IS UNDER THE SKIN

Aired November 29, 2018 – Published December 19, 2018 – Radio-Canada Info – Thousands of Canadian women have had silicone breast implants of a new generation approved in 2006 by Health Canada. Apart from some known complications, these implants were said to be safe for women’s health.

Yet, in recent years, hundreds of women have had their implants removed due to various problems. New studies have shown that silicone implants are associated with the development of autoimmune diseases and a rare form of cancer. Breast Implant Illness is still controversial.

An inquiry conducted by Enquête, in collaboration with the International Consortium of Investigative Journalists, Radio-Canada, CBC and the Toronto Star, revealed that Health Canada approved the release of these implants without long-term studies and allowed manufacturers to not adequately report breast implant-related adverse events for years.

Journalist: Madeleine Roy
Producer: Martyne Bourdeau
Researcher: Benoit Michaud
Cameramen: Éric Carbonneau, Jean-Pierre Gandin, Richard Marion, Laurent Racine, Luc Robida.
Editors: Bernard Lapointe, Rébecca Moréel
Contributors: Many including, Madris Tomes, Device Events Founder & CEO [see Madris @ 27 minutes – 27 seconds]

FDA Chief Calls For Release Of All Data Tracking Problems With Medical Devices

March 27, 2019 – Kaiser Health News – FDA Commissioner Scott Gottlieb announced in a tweet Wednesday that the agency plans to release hundreds of thousands, if not millions, of previously unpublished injury and malfunction reports tied to about 100 medical devices. “We’re now prioritizing making ALL of this data available,” Gottlieb tweeted.

A recent Kaiser Health News investigation revealed the scope of a hidden reporting pathway for device makers, with the agency accepting more than 1.1 million such reports since the start of 2016.

Device makers for nearly 20 years were able to quietly seek an “exemption” from standard, public harm-reporting rules. Devices with such exemptions have included surgical staplers and balloon pumps used in the vessels of heart-surgery patients.

Gottlieb’s tweet also referenced the challenge in opening the database, saying it “wasn’t easily accessible electronically owing to the system’s age. But it’s imperative that all safety information be available to the public.”

The agency made changes to the “alternative summary reporting” program in mid-2017 to require a public report summarizing data filed within the FDA. But nearly two decades of data remained cordoned off from doctors, patients and device-safety researchers who say they could use it to detect problems.

Gottlieb’s announcement was welcomed by Madris Tomes, who has testified to FDA device-review panels about the importance of making summary data on patient harm open to the public. And, with highly configurable software available for businesses to take advantage of, getting the data and making into a format that everyone can understand is now easier than it ever has been.

“That’s the best news I’ve heard in years,” said Tomes, president of Device Events, which makes the FDA device-harm data more user-friendly. “I’m really happy that they’re taking notice and realizing that physicians who couldn’t see this data before were using devices that they wouldn’t have used if they had this data in front of them.”

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Hidden FDA Reports Detail Harm Caused By Scores Of Medical Devices

March 7, 2019 – Kaiser Health News – Dr. Douglas Kwazneski was helping a Pittsburgh surgeon remove an appendix when something jarring happened. The surgical stapler meant to cut and seal the tissue around the appendix locked up.

Kwazneski later turned to the Food and Drug Administration’s public database that tracks medical device failures and “there was nothing,” he said. Yet when he surveyed leading surgeons on the matter, he discovered that more than two-thirds had experienced a stapler malfunction, or knew a peer who did. Such failures can have deadly consequences.

Kwazneski had no idea the FDA had quietly granted the makers of surgical staplers a special “exemption” allowing them to file reports of malfunctions in a database hidden from doctors and from public view.

“I don’t want to sound over-dramatic here, but it seemed like a cover-up,” said Kwazneski, who practiced in Pasco County, Fla., from 2016 through earlier this year.

Madris Tomes, founder and chief executive of Device Events, was a contributor to this article.  Device Events is the only tool that enables healthcare providers to find and analyze the hard-to-find “alternative summary reports” discussed in this article. 

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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.

If these complaints were piling in, in their many, it is a surprise to people that it has continued to be an option of use for birth control. With the risk factors in place and the statistics showing these are higher than might have been previously expected, it is no wonder that these women have fiercely fought to get rid of the device and all the complications that come with it. Luckily for issues like this, the women suffering the consequences can find pain relief and recovery relief as well, in medications or even in some of the products found on Vibes CBD and many other companies like it tailor-make their products for these exact reasons, saving people’s lives when they thought there was nothing that could subside their pain! However, most countries haven’t licensed the use of CBD products yet. Several countries are still deciding on whether to commercialize its usage, while others, like the United States, Canada, and the UK (refer to the CBD oil UK law here), have strict laws regarding its supply and its consumption. That said, it doesn’t take away from the fact that this device was allowed to circulate even after a high amount of complaints came in especially as some of them regarded death! Luckily, something is finally being done about it, those who suffered can receive the support they need and women elsewhere can breathe a sigh of relief that it can no longer cause any more problems.


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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