Maude, the TV show NOT the FDA
Mesh Medical Device News Desk, May 17, 2017 ~ Does MAUDE work? MAUDE is the FDA's central database that’s supposed to identify problems with medical devices that are on the market. Washington University did a review and found it was inadequate.
Printed on the website of Society of American Gastrointestsinal and Endoscopic Surgeons (SAGES),is an audit of the Food and Drug Administration's (FDA) MAUDE database.
The Inadequacy of MAUDE review is from the St. Louis, MO Washington University School of Medicine aimed at testing the limits of the Food and Drug Administration’s database on adverse event reports.
Hernia mesh, WikiCommons
MAUDE, (Manufacturer and User Facility Device Experience) collects reports on complications that come in from patients, attorneys, hospitals, and device users like hospitals.
As we’ve reported, often those reports are first sent to the manufacturer for evaluation. In some cases, the manufacturer discounts that a complication is device-related and that event may never be sent to MAUDE.
This is the current national tracking system for surgical mesh-related adverse events and “this database has been utilized to make claims regarding trends in complications of using hernia mesh materials.”
Dr. Shuddhadeb Ray, Washington U surgical resident
So its accuracy is of critical importance.
Washington University surgical resident Dr. Shuddhadeb Ray, MD and other researchers wanted to find out if abdominal wall hernia repairs done at Wash University were being reported to the MAUDE database.
Medical records were reviewed from their high-volume tertiary academic surgical center in St. Louis during a seven-year period. Included in the number of hernia surgeries was the date, age, BMI, sex, ASA score, the location of the hernia, previous surgeries, previous hernia repairs, the defect size, mesh size, mesh type, operating time, hernia recurrence, and mesh-related adverse events.
In all, there were 2,298 patients with an average of 55 + who underwent incisional, umbilical, apigastric, Spigelian and lumbar hernia repair. Failures included mesh failure, suture retention failure, mesh fragmentation, degradation, and erosions/adhesions needing bowel resection.
Checking with MAUDE, over the same time period using date of operation and type of mesh, for any operative reports and researchers found, “No mesh-related adverse events at the surgical institution were identified within the MAUDE database after audit of all applicable reports (n=4135)."
This leaves one with the conclusion that complication reports are not making it to what is supposed to be the most reliable reporting system to alert the FDA about dangerous devices.
Madris Tomes, Device Events
Madris Tomes, worked at the FDA as an IT project manager in its adverse event reporting program, agrees.
"I would assume if they are using the MAUDE search engine that they are missing a lot of reports. MAUDE only goes back 10 years and the exact brand of mesh is not always specified. OIG (Office of Inspector General) estimates that 86% of adverse events are not submitted to the FDA so I fully agree that MAUDE is not not accurate in that it is just the starting point."
While the Wash University researchers conclude that the MAUDE database is not providing an accurate representation of mesh-related adverse events or trends and they suggest a national centralized system to track the mesh-related complications.
Tomes, founder of Device Events, which harvests FDA data in a usable format, believes a national device registry is not the answer since they are generally not open to the public.
She supports the Medical Device Guardians Act, which encourages reporting of complications by care providers directly to the FDA so the complications cannot be filtered by manufacturers.
She also supports a UDI (Unique Device Identification), like a bar code for medical devices, so that the exact type of mesh will be known if there is a negative outcome. The UDI was signed into law a decade ago as part of the Food and Drug Administration Amendments Act of 2007.
Under the act, (here) by September 24, 2018, which is five years after publication of the final rule, a class II device is required to be labeled with a UDI. ###
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