At the 19th World Congress of International Federation for the Surgery of Obesity & Metabolic Disorders (IFSO 2014), Ethicon, a subsidiary of Johnson & Johnson, announced the release of three new and improved products for bariatric procedures, like gastric bypass surgery. These products will hopefully address the issues and defects for which other gastric bypass stomach staplers were recalled.

Obesity is an ever growing epidemic. Many individuals who try, but fail, to lose weight will often turn to weight loss surgery to fix the problem. The most common of these procedures is gastric bypass surgery, wherein the stomach is shrunk. It is estimated that in the United States, around 177,000 individuals undergo this operation annually.

At the conference, Michael del Prado, Ethicon Group chairman, said, “Ethicon, as part of the largest healthcare company in the world, is committed to leading the way to address the burden of obesity for patients and healthcare systems. Our science-based portfolio for obesity and metabolic diseases is among the most comprehensive in the industry, and we continue to bring forward innovations that fill clinical needs and advance patient care.”

These new innovations will be welcome. Currently, Ethicon Echelon’s stomach staplers own close to 60 percent of the gastric bypass stapler market. This also means they own two-thirds of the annually reported stomach stapler complications, which stands at 8,000 to 9,000 per year.

The new system Ethicon is releasing, the Echelon Flex GST system, is designed to address some bypass surgery issues by providing a better grip so there is less tissue slippage.

Bariatric Surgery Problems

Gastric bypass surgery complications are nothing new. Some injuries that can occur from a stapler misfire or lack of closure can include infections, hemorrhaging, and staple line leaks or separation. These issues cause sufferers pain, can create a need for reoperation, and in some cases, death.

Since Ethicon Endo-Surgery started to manufacture the cutter-stapler in 1999, reports started to come in concerning staple line failures. There were issues with misfiring and failures to close bypass suture lines. For the latter, the company blamed the surgeons, saying the fault was with the size of the staple chosen.

Doctors argue this point, and some juries agree. The most telling case was a $5 million verdict in 2007 to a Pennsylvania woman’s family when she died from staple complications in a gastric bypass surgery.

During the trial, Johnson & Johnson said that an incorrect sized staple was used, an issue of surgeon’s error. The jury, however, found a design defect, concluding that surgeons have no way to accurately determine the thickness of stomach tissue in order to always choose the proper staple cartridge.

In May 2013, Ethicon issued a Class II urgent world-wide recall of their Echelon 60 mm black reload staples used to close the stomach during reduction surgery. The recall included over 57,000 units “due to the potential for incomplete staple line formation from reload damage during the firing sequence.”

Ethicon does not stand alone. Other stapler makers, like Covidien, have also been accused by patients for making and selling defective products.