What are Surgical Staplers Used For?
Surgical staplers are medical devices used to cut and seal blood vessels and tissue during gastrointestinal, gynecologic, colorectal, vascular, and thoracic surgeries. The devices are considered faster and easier to use than traditional nylon sutures, and most useful for rapid wound closure when operating time is of concern. The purported benefits of surgical staples is that they may facilitate wound healing by averting wound edges, but many of the devices have been found to be allegedly defective, posing a significant health risk to patients treated with the devices.
What’s the Problem?
The FDA has received thousands of reports of surgical stapler devices misfiring, or failing to fire during use, which have resulted in “bleeding, sepsis, tearing of internal tissues and organs, increased risk of cancer recurrence, and death,” the agency said.
If you or a loved one has been injured by a surgical stapler device, you should contact us immediately. You may be entitled to compensation through the filing of a lawsuit, and our lawyers can help.
Surgical Stapler Injuries
Some of the most commonly reported injuries associated with malfunctioning surgical staplers include:
- Intestinal dysfunction (i.e. diarrhea, constipation)
- Occlusion of gastrointestinal tract
- Organ damage
- Severe pain
- Bleeding/blood loss
- And more
FDA Investigation on Surgical Stapler Malfunctions
A review by the Food & Drug Administration, which included at least 7 years of hidden reports that were not added to the public Manufacturer and User Facility Device Experience (MAUDE) database, found that “from January 1, 2011 to March 31, 2018, the FDA received more than 41,000 individual medical device reports for surgical staplers and staples for internal use, including 366 deaths, more than 9,000 serious injuries, and more than 32,000 malfunctions.”
FDA in March 2019 sent a letter to healthcare providers stating that it is reevaluating the safety of surgical staplers, and may choose to place them in another category which would grant the agency greater authority in testing and restricting the devices.
A separate investigation conducted by Kaiser Health Network found that in 2016 alone, nearly 10,000 reports of surgical stapler malfunction were submitted to MAUDE. That same year, the database reported less than 100 injuries or malfunctions associated with the devices.
Gastric Staple-Line Failures in Bariatric / Gastric Bypass Surgery
In May 2007, a jury found that a woman’s wrongful death was caused by a defective surgical stapler, manufactured by Ethicon, Endo-Surgery, Inc., a subsidiary of pharmaceutical giant Johnson & Johnson. It was determined that the Ethicon stapler was defective because it failed to form proper staples, allowing her stomach contents to leak into her intestinal cavity. The jury in this case awarded the family of the victim $5 million.
Complications from Defective Surgical Staplers in Gastric Bypass Surgery
Defective surgical staplers used during gastric bypass surgery may cause serious, life-threatening complications and injuries including:
- Dehiscence (separation of areas that are stitched or stapled together)
- Anastomotic leakage
- Leaks from staple lines
Coping with a Gastric Bypass Complication: Although not readily apparent in most cases, a loved one’s infection, re operation, death or other various bariatric injuries may have been caused by a defective surgical stapler manufactured by Ethicon or U.S. Surgical.
Do I have a Surgical Stapler Lawsuit?
The Medical Device Litigation Group at our law firm is an experienced team of trial lawyers that focus exclusively on the representation of plaintiffs in surgical stapler lawsuits. We are pursuing individual litigation nationwide and currently accepting new injury and death cases in all 50 states.
Again, if you suffered an injury after being treated with a surgical stapler device, you should contact us immediately. You may be entitled to compensation for your injuries, and our lawyers can help.