Surgical staplers and staples are common medical devices that are used in many surgeries. The staplers and staples are used internally and are designed to cut tissue or vessels and then seal them quickly and easily. Unfortunately, there has been an increasing number of reports of injuries and even death resulting from the use of defective surgical staplers.
Physicians have trouble operating surgical staplers because of several design defects. There is no tissue thickness indicator or force of pull indicator on the device which leaves the doctor frequently guessing how to accurately use the device. This can result in a misfire or failure to properly form the staple. The devices also do not provide physicians with adequate instructions on how to operate the device.
Injuries have been caused by mechanical malfunctions, such as the device cutting the tissue without deploying the staples or a misfiring of the device that leads to incomplete staple lines and malformed staples. These malfunctions can lead to serious injuries that require additional surgeries.
The most frequent injuries happen during gastrointestinal, bowel, or gastric bypass surgeries. Injuries have also occurred in bariatric, lung, thoracic, cardiovascular and appendectomy surgeries. Often times the stapler malfunctions cause bowel leakage, sepsis, organ or tissue damage, fistula formation, and even death.
FDA Alert on Surgical Staplers
In early 2019, the U.S. Food and Drug Administration issued a letter to healthcare providers describing the problems that have been reported about surgical staplers and recommended actions for safe use of surgical staplers.
One of the biggest surgical stapler manufacturers issued multiple high risk recalls for thousands of its devices, but there are still several unsafe staplers remaining on the market.
The FDA is also proposing to reclassify surgical staplers from a Class I to Class II medical device. This means there would be more controls and review from the FDA before a surgical stapler device can be put on the market.
Surgical Stapler Lawsuits
The attorneys at Baron & Budd are currently investigating surgical stapler lawsuits and the serious injuries associated with these defective devices. If you had an internal surgery where a surgical stapler was used and you suffered an injury as a result of a stapler malfunction or misfire, we encourage you to call one of our lawyers at 866-723-1890 or complete the online form to get started. You may be eligible for compensation for your injuries and suffering.