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Signals from Device Events
January 2019

Signals is a quarterly medical device adverse events newsletter.


NOTE: The following Adverse Event information was extracted from the FDA MAUDE database using Device Events, a cloud-based software service that extracts, consolidates, and provides comprehensive reports and trends on the millions of medical device adverse event reports submitted to the FDA. 
               - PRODUCT CODE: FWM
               - PRODUCT CODE: FTR
               -PRODUCT CODE: LCJ

  • Adverse Events Reported to the FDA through end of 2018
    • Total: 49,159
    • Deaths - 116
    • Malfunctions - 3,975
    • Injuries - 40,401
    • Other - 4,667
  • Recalls - 8 [2-2015; 5-2016; 1-2017]

Breast Implants - Adverse Event Trend - All Event Types
Alternative Summary Reports: A manufacturer typically reports adverse events to the FDA via MDR (medical device report). Exceptions are provided to manufacturers to submit known malfunctions and minor injuries via Alternative Summary Report(ASR) format (typically a spreadsheet containing dozens to thousands of adverse events in a single report).  In early 2017, Device Events discovered that ruptures and device explants/replacements were being submitted via ASR for the greater part of 10 years. This made it appear that there were very few reportable events from 2001 – 2016. In reality, thousands of adverse events that were MDR-reportable events were submitted in the incorrect format (ASR rather than MDR). ASRs are not publicly viewable in MAUDE and are difficult to impossible to receive via FOIA request. The result is that, to the providers and patients seeking information on the safety of the implants via MAUDE, would think that the injuries and deaths were only a problem in the late 1990s.

Breast Implants - Adverse Event Trend - Deaths

Breast Implants - Adverse Event Trend - Injuries

Breast Implants - Adverse Event Trend - Malfunctions


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

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.

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.

Madris Tomes, Founder and CEO of Device Events, was a contributors to this article.  
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The Implant Files Video Report 

The Implant Files is a global investigation that tracks the harm caused by medical devices that have been tested inadequately or not at all. Led by editors and reporters from the International Consortium of Investigative Journalists, it took a year to plan and another year to complete. ICIJ partnered with more than 250 journalists in 36 countries to examine how devices are tested, approved, marketed and monitored.  Anchoring the probe is an analysis of more than 8 million device-related health records, including death and injury reports and recalls. 

Madris Tomes, Founder & CEO of Device Events, was interviewed as a subject matter expert. Her interview segments are:

  • At Time: 29:44 - Ms Tomes is interviewed about adverse event reporting associated with Vagus Nerve Simulator (VNS) devices.
  • At Time: 37:21 - Ms Tomes is interviewed about how some manufacturers are reporting adverse events incorrectly.
  • At Time: 1:13:25 - Ms Tomes is interviewed about Alternative Summary Reports and in particular how breast implant adverse events have been reported.
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Allergan Faces Fresh Woes as Investor Sue

January 9, 2019 - ICIJ - Implant Files - Investors have filed a class action lawsuit against leading breast implant manufacturer Allergan, alleging that the company concealed from them both the association between textured breast implants and a rare form of cancer and the threat this link posed to Allergan’s regulatory approvals.

The suit adds to mounting setbacks for Allergan in connection to its textured implants, which were recently suspended from the market in Europe and Brazil due to concerns about elevated cancer risks among women who receive them.

Last November, the International Consortium of Investigative Journalists published an investigation revealing that women around the world continue to suffer health problems after receiving breast implants.

The report, which was part of ICIJ’s Implant Files investigation on the medical device industry and its overseers, examined health threats including a form of cancer known as breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) that occurs almost exclusively among women with textured breast implants.  READ MORE...

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