In the last several years, the number of individuals opting for bariatric surgery to help them lose weight has greatly increased. Bariatric surgery refers to a group of surgical procedures that assist an individual in losing a great deal of weight rapidly by modifying the gastro-intestinal tract. Bariatric surgery is only intended for individuals that are obese and have been unable to lose weight by other means, such as the modification of their diet and increasing the amount of exercise they perform on a regular basis.
Recently, US Food and Drug Administration (FDA) officials have begun to receive reports about issues with the surgical staples and medical staplers manufactured by the two major suppliers for the products. These suppliers, Ethicon and US Surgical, provide nearly 100% of all the surgical staplers for bariatric surgery in the nation. At least 9,000 reports about complications from the devices have been made to the FDA to date, as well as approximately 100 reports of deaths associated with the staples and staplers.
The Details of Bariatric Surgery
Bariatric surgery generally involves segregating a portion of the gastro-intestinal tract and making it much shorter or smaller so that less food can be eaten at a single sitting and a lesser amount of calories are absorbed into the body. In many cases, the segregated portion of the gastro-intestinal tract is stapled closed with surgical staples using a specially designed stapler in order to ensure that no food or nutrients can get into the closed off area.
The result is that individuals that have undergone bariatric surgery begin to lose excess weight quickly, increasing their ability to function normally and reducing their risk of obesity related complications. Bariatric surgical procedures do not include procedures for the surgical removal of fat, such as a liposuction or an abdominoplasty. Bariatric surgery is typically performed while the patient is under general anesthetic and has a risk of a number of different complications.
Out of all the individuals that have bariatric surgery in any given year, roughly 40% of them can expect to experience a complication from the procedure. In some cases, the bariatric surgery works too well and blocks too many calories and nutrients from entering the body. There have also been reports of incisional hernias occurring at the surgical site, requiring that the individual undergo additional surgery to repair the hernia. Some individuals experienced infections after their bariatric surgery and many had complications that required hospitalization to treat.
Surgical Staple Complications
Recently, US Food and Drug Administration (FDA) officials have begun to receive reports about issues with the surgical staples and medical staplers manufactured by the two major suppliers for the products. These suppliers, Ethicon and US Surgical, provide nearly 100% of all the surgical staplers for bariatric surgery in the nation.
At least 9,000 reports about complications from the devices have been made to the FDA to date, as well as approximately 100 reports of deaths associated with the staples and staplers. The issues associated with the staples and the medical staplers used in bariatric surgery occur when the staples do not close all of the way or the stapler fails to puncture all of the way through the tissue.
This causes the site of the surgery to leak, allowing fluid from the stomach to flow into the abdominal cavity. This can cause a number of complications that can be life-threatening and require hospitalization to treat. Complications from bariatric surgery cause many of the individuals that undergo the surgery to need emergency medical treatment within six months of having the surgical procedure.
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Defective Sugical Stapler Alert
In May 2007, a jury found that a woman’s death was caused by a defective surgical stapler. The jury awarded the victim's family $5 million.
To date, the FDA has received reports of approximately 100 deaths related to surgical staplers. In addition, they have received approximately 9,000 reports of “adverse events”, including injuries and complications from surgical staples and the stapler unit itself.
Learn More: Defective Surgical Staplers Lawsuit
