Surgical staples, including those used in some types of gastric surgery, have recently come under scrutiny over safety concerns. The U.S. Food and Drug Administration (FDA) released several statements on the safety of stomach staples after receiving thousands of complaints about complications including reports of more than 100 deaths.

Surgical staples are used in a number of different surgeries, including weight loss surgery, sometimes called “stomach stapling.” In these gastric surgeries, the effective size of the stomach is reduced, either with stomach staples, gastric bands, or other methods to close off most of the stomach. This makes people feel fuller with less food, ideally leading to weight loss. However, it is considered a high-risk procedure, typically only employed in patients who are morbidly obese — or obese and already suffering from complications of excessive weight, such as diabetes or heart disease.

The FDA has several systems for tracking complications related to drugs and medical devices, though the data is often preliminary. Reports like this draw from these sources of data and make recommendations or present the agency’s understanding of the data.

In the FDA’s first statement on the issue, the agency said it had received between 8,000 and 9,000 adverse event reports related to surgical staples. Of these, 90 percent were device malfunctions, with problems related to the stomach staples failing to fire, misfiring, or the suture lines falling apart. The FDA states that stomach staples theoretically simplify complex procedures and shorten surgical times, but when complications like this arise, the outcome can be just the opposite.

A FDA also provides greater detail about staple-linked death linked to problems connected to staple complications. On this FDA web page, the FDA states it has received 112 reports of deaths linked to surgical staple complications. This includes the type of surgical staples used in gastric surgeries such as weight loss surgeries. According to FDA data, roughly a third of the deaths were associated with prolonged or repeated surgery due to problems with staples, with another third associated with bleeding. Nearly half (45 percent) were connected to a scenario in which stomach staples or other surgical staples’ suture lines fall apart.

According to the FDA, the agency is conducting a study and analysis to better understand the risk of staples like those used in stomach stapling surgery.

Lawsuits have been filed by patients who allege they suffered complications from stomach stapling surgery. These lawsuits allege that the makers of surgical staples, including stomach staples, were aware of the risk of complications like those reported to the FDA, and failed to act on these concerns.