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 staples are specialized staples used in surgery in place of sutures to close skin wounds, connect or remove parts of the bowel or lungs. The use of staples over sutures reduces the local inflammatory response, the width of the wound, and the time it takes to close.
Response to Defective Medical Devices From FDA
The FDA conducted observations of the medical devices, surgical staplers, and implantable staples to make a full analysis of their safety on patients. The FDA report showed 41,000 separate medical device reports were associated with surgical staplers and staples for internal use, and the time period of these reports varied from January 1, 2011, to March 31, 2018. During this time, the data presented over 32,00 malfunctions with the device, over 9,000 serious injuries and sadly, 366 deaths in patients. The FDA believes that the prime reason this is happening is that these medical devices are not functioning properly, as the issues most often reported are:
• The surgical stapler misfired
• The surgical stapler had difficulty firing
• The surgical stapler failed to fire
The FDA’s Recommendations
The FDA issued a letter to medical professionals for recommendations they should follow when using surgical staplers and staples. This will help medical personnel avoid any prior issues reported in the analysis of surgical staplers and to help overall safety for patients.
The recommendations include:
• 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
As the large number of injuries continued to grow due to the malfunctioning surgical staplers, the FDA held a public meeting with the General and Plastic Surgery Devices Panel of the Medical Devices Advisory on March 25th and 26th of 2019. The meeting was held to discuss reclassifying surgical staplers for internal use as Class II medical devices and better ways to regulate the device.
Side Effects of Defective Surgical Staplers
Keep in mind that doctor negligence or a defective device can cause extreme health issues for patients, including things like severe injuries, prolonged surgeries, and additional corrective surgeries. Often times patients won’t experience side effects until a few weeks later as one of the main risks is infection around the wound area. This can happen when bacteria gets around the wound and is not treated properly.
Other health-related complications of defective staples include:
• Bleeding
• Fistula Formation
• Sepsis
• Tearing of internal organs and tissues
• Increased risk of cancer recurrence
• Death
With proper care and medical equipment, all risks and side effects can be avoided. Typically these devices are used in surgeries where the staplers are being applied on delicate organs that include a high risk of leakage in the body part.
Surgeries that have resulted in lawsuits include:
• Appendectomy
• Colostomies
• Gastric Bypass Surgery (Bariatric Surgery)
• Heart Surgery
• Lung Surgery
• Neck/Thoracic Surgery
Reporting Injuries Caused By Malfunctioning Surgical Staplers
While continuing to get to the root of the issue with surgical staples, 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. Reporting issues through the FDA Safety Information and Adverse Event Reporting program can help the FDA protect patients and prevent future injuries. Medical professionals should 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. Each of these lawsuits differs under different state laws. Under strict liability, plaintiffs must build a case that can prove the manufacturer’s device was defective, used for its intended purpose, and caused an injury or death. Regardless of the manufacturers showing that they did all procedures to ensure a device with no defects or harm, this would not be a valid defense.
Get Legal Help From The Eichholz Law Firm
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 The Eichholz Law Firm 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.
References
- 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.