On March 8, 2019, the United States Food and Drug Administration announced a plan to increase the safety of surgical stapler devices. Surgical Staples are used to connect tissues during surgery and have been viewed as being faster and easier to use than traditional nylon sutures. However, this convenience may come at the expense of the patients well being.
Surgical staplers cut and seal blood vessels and tissue. When the staples misfire or fail to fire, patients can bleed profusely and suffer catastrophic consequences, even death. The FDA has said that stapler malfunction or misuse can lead to “bleeding, sepsis, tearing of internal tissues and organs, increased risk of cancer recurrence, and death.”
The FDA Analyzed the medical device reports submitted for both surgical staplers and implantable staples and obtained a comprehensive view of the safety profiles and inherent risks associated. The analysis, which is ongoing, found that from January 1, 2011 – March 31, 2019, the FDA received over 41,000 reports regarding surgical staplers including:
- 366 deaths;
- over 9,000 serious injuries; and,
- over 32,000 malfunctions.
The FDA believes the majority of the reported problems can be attributed to malfunctioning surgical staplers. The effectiveness of surgical staples is largely contingent on proper function and use of the stapler. The most common problems reported to the FDA are
- opening of the staple line or malformation of staples;
- difficulty in firing;
- failure of the stapler to fire the staple; and,
- misapplied staples (e.g., user applying staples to the wrong tissue or applying staples of the wrong size to the tissue).
Surgical stapler and staple malfunctions or misuse have resulted in increased surgical duration, unplanned surgical interventions, which have lead to additional complications such as:
- fistula formation;
- tearing of internal tissues and organs;
- increased risk of cancer recurrence, and
The FDA has identified this as a class I recall, their most serious recall. This recall is used when serious injury or death may occur from the usage of the below staplers.
- Endo-Surgery Curved Intraluminal Stapler with Adjustable Height Staples and
- Endo-Surgery Endoscopic Curved Intraluminal Stapler with Adjustable Height Staples
- Product Codes: CDH21A, CDH25A, CDH29A, CDH33A, ECS21A, ECS25A, ECS29A, ECS33A (Product codes are located on the front of the single unit carton.)
- Manufacturing Dates: March 6, 2018 to March 6, 2019
- Distribution Dates: March 15, 2018 to March 8, 2019
- Devices Recalled in the U.S.: 92,496
- Date Initiated by Firm: April 11, 2019
Usage of surgical staplers and staples is wide due to their convenience and ease of use. Commonly, surgical staplers are used in hard to reach areas of the body – such as gastrointestinal, colorectal, vascular and thoracic.
Types of surgeries where the use of a stapler regularly include:
- Removing part of an organ (resection)
- Cutting through organs and tissues (transection)
- Creating connections between structures (anastomoses)
If you had surgery as described above, there is a high likelihood surgical staples were used and you may be entitled to compensation.
Numerous patients have had surgeries where a surgical stapler was used and worked as intended. Unfortunately, many have not. Based on the information provided by the FDA and our own research, these are the common injuries being reported:
- Uncontrolled diarrhea, constipation, and severe stomach cramping
- Block or occlusion of the intestinal tract
- Damage to internal organs
- Severe pain
- Infection including sepsis
- Bleeding and extensive blood loss
If you have suffered any of the injuries listed above you may have a surgical stapler lawsuit claim.
In most cases, a patient that has suffered from one of the above injuries and has had to undergo repeat surgical procedures and is more likely to be a surgical stapler lawsuit victim.
If you or a loved one had surgery where a surgical stapler or surgical staples were used and experienced any of the above symptoms, please give us a call to discuss the specifics of your case.
Our attorneys are currently evaluating and investigating claims on behalf of patients who have been injured during surgery due to surgical stapler misuse or malfunction. If you have been injured during surgery, and believe that you qualify for a surgical stapler lawsuit please contact us immediately.