Public Citizen – June 10, 2020 – Michael A. Carome, M.D. – IMPLANTED SPINAL CORD STIMULATORS FOR PAIN RELIEF – Illustrating the FDA’s Dangerously Lax Oversight of High-Risk Implantable Medical Device

Executive Summary

For years, numerous commentators and patient safety advocates, including Public Citizen, have criticized the Food and Drug Administration’s (FDA’s) dangerously lax regulatory oversight of medical devices. The goals of this report, which was prompted by concerns about the safety of implanted spinal cord stimulators for pain relief that were raised in a 2018 Associated Press investigation by Weiss and Mohr,1 were to better understand the history of the FDA’s regulatory oversight of these devices, identify the deficiencies in this oversight that endangered patients, and recommend necessary changes to address those deficiencies.

In the US recently in states such as California, there have been legal innovations to aid in the legalization of medically prescribed marijuana that can be given to those suffering from excessive chronic pain. As a result companies similar to Greenbox and medically licensed dispensaries have been able to provide services to those with prescriptions that make taking this alternative medication easier.

In other countries, people have been heading down different paths when it comes to pain relief options. For example, CBD oil from has become popular as an option for those suffering from spinal, and other, injuries in the UK. Blessed CBD and other providers of these products have their work cut out in the US, however, where manual devices hold a larger market share.

Still, with the status quo as it is, it is very much worthwhile for us to investigate these devices, to see if they are able to provide the pain relief that they are touted to accomplish. If they do work, then the “lax” oversight is justified. If they do not, then there may be a push towards alternative options opening onto mass markets.

Madris Tomes, Device Events Founder & CEO, was a contributor to the report providing adverse events metrics.

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‘They killed her’: Why are breast implants still putting millions of women at risk?

May 18, 2020 – FORTUNE – ARTICLE BY MARIA ASPAN – Allergan’s “medical aesthetics” products helped persuade AbbVie to buy the company. But what if the devices driving profit are also endangering women’s health?

“The breast implants that are on the market right now all have issues,” says Madris Tomes, a former FDA manager who tracks reported medical device failures at her Device Events firm. “I wouldn’t recommend them to anyone that I care about.”

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Signals Newsletter – Apr 2020 – Spinal Stabilization and Fusion Systems

KWP                      – Appliance, Fixation, Spinal Interlaminal
KWQ                      – Appliance, Fixation, Spinal Intervertebral Boday
MNH                      – Orthosis, Spondylolisthesis Spinal Fixation
MNI                        – Orthosis, Spinal Pedicle Fixation
KNB                       – Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
OSH                       – Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis




View Signals Newsletter – April 2020 – Spinal Stabilization and Fusion Systems

The U.S. needs more ventilators. Why can’t it make them in time?

March 25, 2020 – FORTUNE – ARTICLE BY MARIA ASPAN AND NAOMI XU ELEGANT – More hands are rapidly coming on deck to make ventilators for American coronavirus victims. There still might not be enough.

Madris Tomes, Device Events Founder & CEO and other experts warn “that the FDA’s restrictions on medical-grade materials, devices and processes exist for good reason…a rushed and potentially dysfunctional breathing machine can be worse than useless.”

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Leading the Call for Reform of Medical Device Safety Surveillance

December 20, 2019 – JAMA Internal Medicine – Article
Authors: James W. Salazar, MD, MAS1; Rita F. Redberg, MD, MSc1,2
An ideal surveillance system for medical device safety would comprehensively collect data on adverse events across the life span of a device. Preferably, the system would be integrated into electronic health records to allow seamless identification, tracking, and real-time reporting of device-associated adverse events. Moreover, it would parse adverse events to detect substantial safety signals and underperforming devices. Such a system would also allow implementation of corrective actions in a swift and commensurate manner.

Acknowledgements: We thank Madris Tomes, MBA, chief executive officer of Device Events, for her information on the history of unique identifiers and data on the number of adverse events entered in the US Food and Drug Administrations Manufacturer and User Facility Device Experience database. She was not compensated for is contribution.

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]