Product Liability and Medical Device Lawyer investigating surgical staple injury and surgical error lawsuits for injured plaintiffs nationwide.

The U.S. Food and Drug Administration (FDA) has said that between January 2011, and March 2018, it received over 41,000 medical device reports involving surgical staplers and staples for internal use. The surgical staple injury reports included 366 deaths, around 9,000 severe injuries, and 32,000 stapler malfunctions.

Common safety concerns include malformed, defective staples and staple misfiring. Surgical staple injury related to operator error are also frequent, spurring on new product liability and medical malpractice cases.

Surgical staplers are critical instruments for many operating doctors. The devices cut and seal blood vessels and tissue in a variety of invasive surgeries. But if the staplers are used incorrectly or they fail to fire, patients can bleed profusely and risk injury and death. The FDA says surgical stapler malfunctions and surgeon malpractice can cause one or more of the following surgical staple injury:

  • Bleeding
  • Sepsis
  • Internal tissue damage
  • Organ perforation
  • Increased risk of cancer recurrence
  • Wrongful death

Joe Lyon is an experienced product liability and medical malpractice attorney reviewing surgical staple injury cases for injured plaintiffs nationwide.

Surgical Staple Injury & Safe Stapler Use

Surgical staplers are used for both external and internal operations. They can be used externally to close wounds on the scalp or the torso. Surgical staples are helpful in many medical situations because of quick placement, little tissue reaction, a low risk of infection, and a high-tension would closure.

For internal use, surgical staplers are commonly used in gastrointestinal, gynecologic, thoracic, and other surgeries. Uses are varied and can include organ removal, organ and tissue incisions, connection structures, and closing wounds.

However, the FDA has its safety concerns, noted in a letter to healthcare providers, issued in March 2019. The warning aims to assist stapler manufacturers in the labeling process regarding information about specific health risks, device limitations, and directions for stapler use. Currently, surgical staplers for internal use do not require a pre-market submission to the FDA for approval.

The FDA alert follows an alarming number of medical device reports associated with surgical stapler injury and death.

Surgical Staple Defects & Lawsuits

Lawsuits have been filed against surgical stapler manufacturers, including Ethicon and Medtronic, due to design defects, manufacturing defects, failures to warn and failures to properly test the device prior to distribution.

Surgical staples are commonly used for gastric bypass surgery, lung surgery, neck surgery, heart surgery, colonostomies, and appendectomies. These are everyday procedures, which is concerning for both doctors and patient safety advocates.

In their recent review, the FDA found 90 percent of surgical staple injury cases are due to staple misfiring, and stapler malfunction. Other noted complications include a separation of suture lines, staplers adhering to patient tissue, and staples not forming correctly. Stapler malfunction and improper use of the devices can lead to severe health risks, including death.

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If you or a loved one has suffered a surgical staple injury, and have questions about the legal remedies available to improve quality of life and medical care in Ohio, contact The Lyon Firm (800) 513-2403. You will speak directly with Mr. Lyon, a Cincinnati medical device defect attorney, and he will help you answer critical questions regarding defective surgical stapler lawsuits.