What Is the Problem?
The GastriSail gastric positioning system is manufactured by Covidien, a division of Medtronic. The device was recalled on Feb. 20, 2018, due to “reports of gastric or esophageal perforation occurring where the GastriSail Gastric Positioning device has been used.”
This product was designed for use in gastric bypass and bariatric surgeries for the application of suction, decompression, and to expand the stomach. It also served to drain fluids, among other things.
Medtronic sent an URGENT FIELD SAFETY NOTICE in September 2017, advising that it was recalling all of these devices because there had been 18 reports of perforations.
What Are the Injuries?
A gastrointestinal perforation (GP) occurs when a hole is punctured all the way through the stomach, large bowel, or small intestine. When a GP occurs, the contents of your GI tract may spill into your abdomen and cause a serious infection known as peritonitis. This can lead to sepsis and even death.
A GP can be very painful and is accompanied by nausea, vomiting, and internal bleeding, and often followed by shock. A diagnosis of a GP is usually made by imaging studies that show the presence of free air in the abdomen.
Treatment usually involves fluids, antibiotics, and surgery to repair the perforation. Sometimes, a bowel resection is necessary. Recovery can vary in length and intensity.
What Is the Nature of My Claim?
A product manufacturer has a duty to design and manufacture a reasonably safe product. It also needs to warn of the dangers of using the product. Based on Medtronic’s quick recall, it is likely that the design of this product was unsafe and possibly led to your injuries. It is also likely that Medtronic failed to warn your doctor and/or the hospital of the dangers of perforation with this device. If it had done so, your doctor could have used a safer alternative.
GoldenbergLaw Can Help
For over 31 years, our experienced drug and medical device attorneys have successfully counseled thousands of injured clients through the litigation process and recovered millions of dollars in fair compensation. We believe in “safety through accountability.” We want to help you seek justice for your injuries, and we want to prevent this from happening to others.
Please contact us for a free consultation to learn if you may have a claim. There is no fee unless we recover for you.