When surgical errors occur, the patient and family members often blame the medical team. There is a very good chance the health care professionals are to blame for these errors. However, research shows that manufacturers of medical devices might also need to share in that blame.
In March 2019, a report from the Food and Drug Administration shared concern about the number of adverse medical events tied to the use of surgical staples. From the start of 2011 to the first quarter of 2018, the FDA noted 32,000 malfunctions, 9,000 serious injuries and 366 deaths.
Problems with the staples
There are several specific issues identified by the FDA when it comes to malfunctions:
- Difficult in firing
- Failure to fire
- Malformation of staples
Potential risks of staple malfunctions
When machines do not work as they should, they can lead to more time in the surgical room. The patient might also require additional surgery to right the problems created by the staples. Here are some of the complications that might occur, often before doctors even detect something is wrong:
- Increased risk of cancer returning
- Tearing of internal organs and tissue
- Fistula formation
Contributions to the problem
While the FDA has published some public information regarding this, WebMD believes it also assisted in the coverup of the issue. It shared that the FDA allowed manufacturers to secretly report the malfunctions in a database that medical professionals did not have immediate access to. While manufacturers still report deaths to the public MAUDE database, the risk of injury remained unknown to many health professionals until they personally discovered issues with the devices.
WebMD also reports much higher rates of malfunctions, totaling in the millions over the past 15 years or so. It also shares that staples are not the only devices reported to the secret database. Also on the list are mechanical heart valves and cardiac stents.