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Signals from Device Events
May 2021

Signals is a newsletter that highlights current medical device news and activity.


DEVICE SPOTLIGHT
               Hernia Mesh
 
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 DETAILS
     PRODUCT CODES - DESCRIPTION                                                   
      FTL                          - MESH, SURGICAL, POLYMERIC
      FTM                         - MESH, SURGICAL

     ADVERSE EVENTS RECEIVED BY THE FDA                                     
     Total Reports                        - 51,844
     Injury Reports                         - 48,974
     Malfunction Reports               - 2,209
     Death Reports                        - 388
     Other                                      - 273

     RECALLS                               - 27

Hernia Mesh - All Adverse Event Types Trend 

Hernia Mesh - Death Event Trend


Hernia Mesh - Injury Event Trend



Hernia Mesh - Malfunction Event Trend
IN THE NEWS
In the Net [Hernia Mesh]

HARPER’S MAGAZINE – March 2021 Issue – By Trudy Lieberman


For years, Michael Ransford had known he would need surgery for his umbilical hernia. “People said if it ruptured, it could kill me,” the sixty-year-old farmer told me. The pain from a second hernia, on his right testicle, sent him “through the roof.” In 2016, shortly before Christmas, Ransford had an operation to repair both at Columbia Memorial Hospital, near his home in Ghent, New York.

In a postsurgical report, Ransford’s doctor, Gary Pearlstein, noted that he had repaired both hernias with polypropylene mesh, a type of synthetic netting that is commonly used in such surgeries. Pearlstein used an oval mesh patch on the testicular hernia and a circular mesh patch on the umbilical hernia. The hospital’s records identify the circular mesh as the Proceed Ventral Patch, a device consisting of multiple layers of material, produced by Ethicon, a subsidiary of Johnson and Johnson. The mesh provided “a nice solid repair,” Pearlstein wrote.

Meanwhile, complaints about hernia mesh are stacking up in the FDA’s MAUDE database, where device manufacturers are required to report malfunctions, serious injuries, and deaths. Doctors don’t have an obligation to report such incidents, but many of them, along with patients’ lawyers, are filing complaints, according to Madris Kinard, CEO of Device Events, a firm that reports on recalls and medical devices. Kinard told me that there had been a “drastic spike in hernia mesh cases reported since 2017.” That year, there were 3,149 complaints; in 2020, there were 13,942. Ten years ago, the agency’s Office of the Inspector General estimated that only 14 percent of adverse events caused by devices are ever reported to the FDA. Kinard said this suggests that the number of adverse events linked to hernia mesh is much higher than current statistics show.

Read Full Article…

Hernia Mesh | Uses, Types, Brands and Pros & Cons

Drug Watch – May 5, 2021 – By Terry Turner; Edited By Emily Miller; Medically Reviewed by Dr. John Daller

Hernia mesh, or surgical mesh, is a medical device that supports damaged tissue around hernias as it heals. Surgeons place the mesh across the area surrounding the hernia, attaching it with stitches, staples or glue. Pores in the mesh allow tissue to grow into the device. Hernia mesh is used in nine out of 10 hernia surgeries annually in the U.S.

According to the U.S. Food and Drug Administration, using hernia mesh may improve a patient’s outcome because the surgery and recovery may take less time compared to other treatment options. However, the agency links recalled meshes to many reports of hernia mesh complications. Some patients require hernia mesh removal surgery to treat these complications.

Why Do Surgeons Use Hernia Mesh?

A main reason surgeons use hernia mesh is to lower the risk of a hernia recurring, or coming back.

There is a high chance of hernias returning after repair surgery. Conventional hernia surgery stitches torn tissue back together. Some studies have shown that surgeries using mesh lead to fewer hernia recurrences. Others have found there are other complications that are more common with mesh.

Read Full Article…

HHS shoots down 'flawed' plan to let some devices skip review

Medical Design & Outsourcing - April 15, 2021 - Nancy Crotti 
 

The Biden administration has nixed what it described as a “flawed” Trump-era decision to exempt certain medical devices — including infusion pump controllers and fetal monitors — from regulatory review.

HHS published the original notice in the Federal Register on Jan. 15, shortly before President Joe Biden was set to take office, without speaking with the FDA before doing so, according to an FDA notice set to appear in the Federal Register tomorrow.

The Jan. 15 notice listed 83 Class II devices and one Class 1 device that HHS had exempted from regulatory review during the COVID-19 public health emergency and proposed making their exemption permanent. They included home ventilators, cardiopulmonary bypass pressure gauges, fetal cardiac monitors, long-term extracorporeal support systems, certain imaging software, ethylene oxide sterilizers and aerators, and certain masks (including N95 respirators), gloves and gowns.

FDA watchdog Madris Tomes, CEO of Device Events, told Medical Design & Outsourcing that she was pleased to learn about the withdrawal of the Jan. 15 decision.

“Although adverse event reports can be used to identify signals (patterns of problems with devices), the absence of these reports does not mean that a device is safe and effective,” Tomes said in an email. “Devices are often under-reported. Further review of the notice in January, that has now been withdrawn, acknowledged that assumption was flawed. It is very understandable that in the midst of the pandemic, that some devices would be authorized for use without the formal 510(k) process. However, assuming that an EUA could replace the typical review process for these devices indefinitely was not a good call by HHS, and I’m glad that Dr. Woodcock’s office has recognized and addressed these flawed exemptions.”


Read Full Article...
Amid coronavirus pandemic, Maryland company's single-use medical scopes in high demand

The Baltimore Sun - April 30, 2021 - Hallie Miller
 

The coronavirus pandemic has altered social norms and daily routines, influenced consumer spending and upended the global economy. It also may be changing the way medical professionals examine and operate inside your body.

Reusable medical scopes have long been the standard in patient care settings, despite isolated reports of contamination, infection and even death emerging from hospitals alleged to have failed to fully sanitize the devices. The U.S. Food and Drug Administration says that the risk associated with reusable scopes is “relatively low,” provided that cleaning and reprocessing guidelines are strictly followed.

Hospitals currently are not required to track which patients receive which scopes, which could pose problems in controlling a potential contamination event, said Madris Kinard, a former FDA official and the CEO of Device Events, a company that tracks adverse events and equipment recalls in medical settings.

She said patients may not be aware of the life span of the instruments used to examine their insides.

“I look at it as a systemic issue, that these devices can’t be cleaned,” Kinard said. “If the FDA could identify a better way to clean them, they would’ve tried, and manufacturers are trying too.”

Kinard said there have been 2,600 contamination reports filed to the FDA in the last decade, a figure that may be vastly underreported. Contamination reports decreased in 2020, which Kinard said is likely due either to the introduction of scopes with disposable parts or the number of elective procedures decreasing during the pandemic.


Read Full Article...

ABOUT DEVICE EVENTS
Device Events LLC is a Pennsylvania-based company that provides a cloud-based software service that extracts, consolidates and provides clear and comprehensive metrics and reports on the millions of complex medical device adverse event reports (MDRs) and recalls that have been filed with the FDA. · Our service helps all organizations associated with healthcare by providing them with clear, comprehensive and cost effective access to the most up to date information on problem medical devices. ·  We are committed to making information on problem devices easily accessible to our customers so they can improve health outcomes and patient safety while reducing risk for their organizations.  For more information visit our website at www.deviceevents.com
Copyright © 2021 Device Events, Inc, All rights reserved.


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