Recent reports of defective surgical staplers and staples have patients, doctors, and the U.S. Food and Drug Administration (FDA) concerned.
What Are Surgical Staplers?
Surgical staplers are medical devices that are used to close up wounds or connect tissues. They are used as a substitute for stitches. Using staples is considered quicker, easier, and more uniform. These devices may also be used internally for organs. More doctors have recently used staples because of the reduced risk of inflammation. The staples have also been known to decrease the time it takes to close wounds and the size of the wound.
These products were not approved by the FDA through its PMA process. See our write-up about how medical devices get to the market. Instead, they were cleared by FDA through the 510(k) process. This likely means there will not be preemption arguments used to avoid holding the medical device companies accountable. That has been a problem in the Essure litigation and in the BHR hip litigation.
Response To Defective Medical Devices From FDA
The FDA has provided recommendations on the safety and risk of using these devices to protect patients and decrease the risk of injuries. In addition, The FDA is also planning on providing draft guidance that describes the recommendations to manufacturers of surgical staplers and staples for internal use and what information to include on labels.
During the FDA’s analysis of the medical devices, they examined both surgical staplers and implantable staples for a more complete study of their safety risks. The agency’s report showed that they received 41,000 separate medical device reports associated with surgical staplers and staples for internal use. The reports were from January 1, 2011 to March 31, 2018 and data taken from these reports showed 366 deaths, over 9,000 serious injuries, and over 32,000 device malfunctions. The FDA believes that most of the issues found in the analysis are a result of surgical staplers because the correct usage of staplers is dependent on the device functioning properly. The issues that were reported most often include:
- The surgical stapler misfired
- The surgical stapler had difficulty firing
- The surgical stapler failed to fire
The FDA’s Recommendations
In a letter by the FDA, there are recommendations that medical professionals should follow when using surgical staplers and staples. These recommendations are meant to help medical personnel avoid injuries caused by surgical staplers. Some of the recommendations are:
- Pay close attention to the manufacturer of the staplers’ instructions for use.
- Use the correct staple size and the correct staple cartridge size for the type of tissue and the thickness.
- If there is difficulty squeezing the stapler’s handle, use a different size staple.
- Be aware that manufacturers may use different color coding for labels.
- Always consider other options to use on wounds and tissues, especially if the tissue is swollen, friable, or necrotic.
- Be aware of the surrounding structures near the area where the staples will be used.
- Avoid using staplers on large blood vessels.
- Avoid clamping the stapler on sensitive tissue.
- If the stapler malfunctions during the procedure, tie up the vessel before releasing the stapler.
Public Meeting For Defective Medical Devices
The large number of injuries associated with malfunctioning surgical staplers have caused the FDA to hold an open public meeting of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory. The meeting occurred on March 25 and 26, 2019. The meeting was held to discuss reclassifying surgical staplers for internal use as Class II medical devices.
Side Effects of Defective Surgical Staplers
Malfunctioning or defective surgical staplers may cause severe injuries, prolonged surgeries, and additional corrective surgeries. Patients who have undergone surgery with defective staples may not notice any side effects immediately and will feel normal for a few days.
Staples improperly placed in a patient because of either doctor negligence or a defective device can cause many health-related issues. One of the main risks is infection around the wound area, which happens when bacteria gets near the wound and proper care is not given. There are some patients who may even be allergic to the staples’ materials.
Other health-related complications of defective staples include:
- Fistula formation
- Tearing of internal organs and tissues
- Increased risk of cancer recurrence
All of these risks and side effects can be avoided if proper medical equipment is used and doctors are performing the procedure correctly. These devices are used in many surgeries and adverse events usually arise when the staplers are being used on delicate organs with high risks of leakage. Some of the surgeries that have resulted in lawsuits include:
- Gastric bypass surgery (bariatric surgery)
- Heart surgery
- Lung surgery
- Neck/Thoracic surgery
Reporting Injuries Caused By Malfunctioning Surgical Staplers
The FDA requests that any patient who has undergone surgery and has had adverse experiences or injuries due to surgical staples should file a voluntary report via MedWatch. This is an FDA Safety Information and Adverse Event Reporting program. Reporting issues with these devices can help the FDA protect patients and prevent future injuries. Medical personnel should also report these issues by following the steps outlined by their institution.
Who Is Liable For Defective Surgical Stapler Injuries
Manufacturers of these medical staplers are the primary responsible parties. The two largest manufacturers of surgical staplers are Covidien, PLC and Ethicon (a subsidiary of Johnson & Johnson). In 2015, a jury awarded almost $80 million in a lawsuit against Ethicon. Covidien had to recall its surgical staples in 2012 after a series of severe injuries and three fatalities were associated with their staples.
Cases such as this would be considered a product liability lawsuit. These lawsuits are complicated and differ according to each state. Under strict liability, plaintiffs must prove that the manufacturer’s device was defective, used for its intended purpose, and caused an injury or death. The manufacturer could show that they did all that they could to guarantee a device with no defects, but this would not be a valid defense.
Get Legal Help From KBA Attorneys
If you had surgery involving surgical staplers and have experienced health-related issues from the staples, you may be eligible to file a defective medical device lawsuit and receive compensation for your pain and suffering. Victims of these defective devices can trust the experienced product liability lawyers at KBA Attorneys to hold the responsible parties liable for your losses. Give us a call today to get a free case evaluation and learn how you can get the compensation these manufacturers owe you.
- FDA. “Safe Use of Surgical Staplers and Staples – Letter to Health Care Providers“, U.S. Department of Health and Human Services, https://www.fda.gov/MedicalDevices/Safety/LetterstoHealthCareProviders/ucm632938.htm. Accessed March 28, 2019.