Sage Datko  |  October 2, 2020

Category: Legal News

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Surgery using an Ethicon stapler
Surgical staplers are commonly used by doctors to close wounds and incisions, however, these devices may be prone to malfunctioning and potentially causing serious complications. A recent surgical staples lawsuit claims the device resulted in a string of medical complications and injuries.

Woman Says Ethicon Stapler Caused Serious Surgical Complications

Plaintiff Yolanda C. filed a lawsuit against Ethicon Endo-Surgery in September alleging injuries caused by a malfunctioning surgical stapler.

According to Yolanda, she had surgery in October 2018 to remove potentially malignant tissue from her colon. Although the surgery began laparoscopically, her doctor ended up performing an open procedure in order to gain better access to the area. After the section of tissue was removed, the doctor used an Ethicon stapler to close the site. Following surgery, Yolanda was discharged to a nursing facility to complete her recovery.

Within a few days of being discharged, Yolanda began experiencing fatigue and loss of appetite. She went to an emergency care center, where a CT scan showed she had several pockets of fluid build up in her abdomen. She required emergency transportation to a hospital, where she was placed on IV antibiotics and had multiple drains placed to remove the fluid. Her condition briefly improved, but a second CT scan on November 3 indicated that she had another fluid collection. Due to these continued fluid build ups, Yolanda had another surgery to determine the cause of the persistent issue. During the second surgery, doctors concluded that the fluid build-ups were caused by a leak in the area that had been stapled. According to the surgical report, a 1 cm gap was found in the area, due to an apparent staple malfunction.

In order to control the fluid build-up, several drains and tubes, including an ileostomy, were inserted in order to remove fluids from Yolanda’s body. However, at least one of these tubes became dislodged, resulting in a third hospital stay. After undergoing another round of antibiotics, Yolanda’s ileostomy tube was removed and she was fitted with a colostomy bag.

According to Yolanda’s Ethicon stapler lawsuit, the initial surgical stapler malfunction was to blame for the string of medical procedures, infections, and hospital stays. She claims that the failure of the staples to close her colon resulted in further surgeries, sepsis, and the need for an ileostomy tube and a colostomy bag.

Medical skin staplerSurgical Stapler Dangers

Yolanda is not the first patient to report serious injuries from a malfunctioning surgical stapler. The U.S. Food and Drug Administration (FDA) received approximately 110,000 reports of malfunctioning staplers between 2011 and 2018. At least 400 of the reports involved the death of a patient, and more than 11,000 were linked to serious injuries.

Additionally, more than half of the reports to the FDA were kept in a private database. While most reports of surgical device malfunctions are housed in a public database that’s searchable by doctors and patients, some 56,000 stapler malfunction reports were hidden from public view.

Keeping data on these devices secret may have made it impossible for doctors or patients to make informed decisions on the stapler’s safety.

According to CNN, after the existence of the secret database was revealed, the FDA announced a plan to review the safety of surgical staplers and potentially reclassify them as a higher-risk device. At the time, surgical staplers were included in the FDA’s lowest-risk category, along with other medical devices such as bandages or tongue depressors. In April 2019, the FDA announced a Class I recall on Ethicon’s Endo-Surgery Intraluminal Staplers.  A Class I recall is the most serious type of recall and indicates the possibility of serious injury or death from the recalled device.

Do You Qualify to File an Ethicon Stapler Lawsuit?

If you experienced complications due to a malfunctioning or misused surgical stapler, you may be able to speak with a qualified attorney about the specifics of your case. Some victims of stapler injuries are eligible to join or file a surgical staples class action lawsuit against Ethicon and pursue compensation for their injuries, pain and suffering, medical expenses, and other costs related to the stapler malfunction.

Yolanda’s Ethicon Stapler Lawsuit is Case No: 4:20-cv-03255, filed in the U.S. District Court for the Southern District of Texas, Houston Division.

Join a Free Ethicon Surgical Stapler Lawsuit Investigation

If you or a loved one suffered surgical complications caused by internal staples, you may qualify to join an Ethicon surgical stapler lawsuit investigation.

See if you qualify by filling out the free form on this page. 

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