Signals from Device Events
April 2019
Signals is a quarterly medical device adverse events newsletter.
DEVICE SPOTLIGHT
Knee Prosthesis (Example)
NOTE: The following Adverse Event data 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 that have been submitted to the FDA.
DEVICE NAME:
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
PRODUCT CODE: JWH
REPORTING PERIOD: 1/1/2009 - 3/31/2019
- Adverse Events Received by the FDA
- Total: 80,950
- Deaths - 203
- Malfunctions - 10,902
- Injuries - 68,188
- Other - 1,657
Knees Replacements - Adverse Event Trend - All Event Types
Knees Replacement - Adverse Event Trend - Deaths
Knee Replacement - Adverse Event Trend - Injuries
Knee Replacement- Adverse Event Trend - Malfunctions
IN THE NEWS
[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.
Madris Tomes, Founder and CEO of Device Events, was a contributors to this video. See Madris' interview at 27:22 of the video. VIEW YouTube VIDEO...
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FDA Chief Call 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announced in a tweet Wednesday that the agency plans to release hundreds of thousands, if not millions, of previously unpublished injury and malfunction reports tied to about 100 medical devices.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.
“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.” Read More…
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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." Read More…
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