FDA planning to review safety of surgical staplers after thousands of ...

The US Food and Drug Administration (FDA) is planning to review surgical staplers after it emerged that manufacturers were allowed to 'hide' malfunction reports.  

Officials say that faulty staplers, which close internal surgical wounds, can lead to bleeding, organ damage, sepsis and even death. 

In a letter sent to health care providers, the FDA said it is setting up a committee to update recommendations to hopefully reduce the risk of using the devices.

It comes after a Kaiser Health News investigation found that the FDA allowed the makers of surgical staplers an 'exemption' to file malfunction reports in a separate database from the one available to the general public. 

The news website found that, in some years, only a couple of hundred of injuries or malfunctions were made publicly available while as many as 10,000 reports were filed in the hidden database.

The US Food and Drug Administration is planning to review thousands of malfunction reports of surgical staplers that were 'hidden' from the public database between 2011 and 2018. Pictured: A stapler made by Medtronic, one of the companies that received the 'exemption'

The US Food and Drug Administration is planning to review thousands of malfunction reports of surgical staplers that were 'hidden' from the public database between 2011 and 2018. Pictured: A stapler made by Medtronic, one of the companies that received the 'exemption'

Surgical staples are used to close both internal and external wounds.

Doctors have turned to using staples over sutures in recent years because they reduce the amount of wound infections, the size of the wound and the time needed for the wound to heal.

The first staplers were made of stainless steel, but today only half of them are, while the rest are disposable and made from plastic. 

Records from the FDA show that, over the course of seven years, the agency allowed exemptions to be made on malfunctions of both staplers and staples.

Kaiser Health News found that in 2016, there were 10,000 malfunction reports entered into the internal database, but the public database only showed about 100 malfunctions.

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