Surgical staplers are medical devices that close skin wounds without the need for stitches. They are said to be more uniform and quicker. They can also be used internally, in some organs. However, the FDA has received over 9,000 reports of problems with surgical staplers or staples. There have been over 100 reported deaths.Who Manufactures Surgical Staplers?
- Covidien, plc (formerly Tyco and U.S. Surgical): on January 16, 2012, they recalled defective surgical staples used in thoracic/neck surgery, after reports of 13 serious injuries and three surgical staple deaths. These staples sometimes cause injuries near the site of neck surgery.
- Ethicon (Johnson & Johnson subsidiary): a Pennsylvania jury in 2007 discovered that Ethicon’s surgical stapler was defective because it did not properly close an incision during gastric bypass surgery. The woman died because stomach acid leaked into her intestinal cavity. The jury awarded $5 million. Ethicon manufactures approximately two-thirds of the surgical staplers.
There are many reasons why surgical staplers and staples can be defective. In many cases, the manufacturers promote them for use in dangerous situations. In some types of surgery, it can be difficult or impossible to determine how thick the tissue being stapled is. Not knowing means that the surgeon can choose the wrong staple—too small and the area won’t be totally closed, causing leakage or bleeding; too large and the staple can cause more internal damage.
When damage is done, particularly during internal surgery, the patient may appear to be fine for a few days. However, internal bleeding and leakage can cause symptoms such as pain, vomiting, and infection. Doctors must be prepared to address those problems in order to determine the cause.
In other cases, the staples misfire or do not form properly. Jamming can cause the stapler to become stuck to the patient’s tissue, which can cause even more damage when the surgeon attempts to separate it.
We also see medical malpractice cases where the surgeon deviate from the accepted standards of care when they try to use a surgical stapler to create space within the pelvic cavity and then they fire the stapler into bladder tissue. Doctors also sometimes fail to use hand-sewn anastomosis as opposed to the use of a surgical stapler when the procedure and the patient's history do not call for a stapler.What Surgeries are These Staplers Used for?
Defective surgical staplers can be used for almost any type of surgery. However, they are most dangerous when used near sensitive organs, or on organs that can leak dangerous fluids. These are some of the surgeries that we are investigating surgical stapler lawsuits for:
- Gastric bypass surgery/bariatric surgery
- Neck/thoracic surgery
- Lung surgery
- Heart surgery