Hidden FDA Database Concealed Reports of Surgical Stapler Malfunctions
A hidden FDA database of medical device failures was shut down in June 2019. The database contains medical device reports submitted to the FDA via its Alternative Summary Reporting Program from 1999 to 2019. Reports which were sent to this database were not, until recently, made public. The Alternative Summary Reporting Program is a non-public database, unlike the FDA’s MAUDE database which publicly logs medical device failures or defects for public review.
The Alternative Summary Reporting Program seems to have hidden a huge number of reports of malfunctions of surgical staplers. For example, in 2016 there were 84 reports of stapler malfunctions or injuries submitted to the FDA’s public MAUDE database, yet in that same year almost 10,000 reports of malfunctions were submitted via the Alternative Summary Reporting Program.
Growing Concern Over Surgical Stapler Malfunctions
The FDA reports that over 56,000 reports of surgical stapler malfunctions were reported via the Alternative Summary Reporting Program between 2011 and 2018. Deaths must be reported via the MAUDE database, and over 400 surgical staple/stapler deaths were reported to the MAUDE database since 2011.
A 2013 study concluded that patients who have orthopedic surgery and have their wounds closed with surgical staplers face a higher risk of wound infections as compared to patients who had wounds closed with sutures.
A March 2019 FDA letter stated that 366 deaths and more than 9,000 serious injuries resulting from surgical staples and staplers were reported between January 2011 and March 2018.
Types Of Surgical Stapler Injuries:
- Internal tissue tears
- Fistula formation
- Organ tears
Ethicon Recalls Surgical Staplers
Ethicon, a subsidiary of Johnson & Johnson, manufactures the Endo-Surgery Curved Intraluminlal Stapler and the Endo-Surgery Endoscopic Curved Intraluminal Stapler. Ethicon recalled 92,496 of these devices in April 2019. Surgical staplers are commonly used in gastrointestinal tract surgeries.
Surgical Stapler Injury Lawsuit
Nadrich & Cohen and its legal teams are currently representing surgical stapler patients who were injured due to a defective surgical stapler which caused one of the above injuries. The lawyers at Nadrich & Cohen offer a 100% free and confidential surgical stapler case evaluation. If you or a loved one has suffered a surgical stapler injury, immediately contact our office at 1-800-718-4658 for a free consultation.