Surgical staples are used as a quick and efficient alternative to traditional suturing and also serves to join tissue in high-tension areas. Unfortunately, the U.S. Food and Drug Administration (FDA) has issued a Class I Ethicon Stapler Recall on May 14, due to malformed washers creating disfigured staples. The FDA accompanied the recall with an announcement for patients and healthcare providers who may have used the affected products.
The Ethicon Stapler Recall Summarized
The Ethicon stapler recall will affect approximately 92,500 units of the Endo-Surgery Curved Intraluminal Stapler and the Endo-Surgery Endoscopic Curved Intraluminal Stapler models with adjustable height staples with the product codes: CDH21A, CDH25A, CDH29A, CDH33A, ECS21A, ECS25A, ECS29A, ECS33A manufactured and distributed between March 6, 2018, and March 8, 2019.
In their announcement, the FDA stated that the Ethicon stapler recall occurred following a confirmation by Ethicon themselves that uncut washers in the stapler units were creating malformed staples that compromised the staple line’s integrity. According to the FDA announcement, after the washer is cut to confirm the completion of the firing cycle, surgeons were reported to experience a physical and audible crunch.
The FDA and Ethicon initiated the Class I Ethicon stapler recall after it became apparent that use of these intraluminal staplers may cause serious patient harm or death. At this time it has been confirmed that at least two people have been seriously injured. Those injuries have been determined to have occurred due to a misfire of the stapler that resulted in additional resections. One patient experienced a resectioning of their middle rectum, while the other patient had their lower rectum resectioned. Neither time was that the intended area of resectioning.
Included with the Ethicon stapler recall was a disclosure of potential risks and dangers. Some of those risks to patients include:
- Internal Bleeding
- Events leading to permanent ostomy bag use
- Permanent nutritional and digestive issues
- Leakage in the closed area
- Need for additional operations
- Long term antibiotic dependency
- Symptoms requiring additional screenings or closures
Due to the severity of these symptoms, in addition to initiating the Ethicon stapler recall, the FDA has declared that affected products should be taken out of use immediately.
For more information about the potential risks of intraluminal staples, see Parker Waichman’s in-depth coverage of the matter here.
FDA Guidelines In The Wake of The Ethicon Stapler Recall
Following the initiation of the Ethicon stapler recall, the FDA issued a series of warnings and guidelines to healthcare providers and patients. They have suggested alternatives to Ethicon intraluminal staplers that include:
- Manual staplers from other manufacturers
- Powered staplers from other manufacturers
- Open surgery with an alternative of sewn closure such as anastomosis
- Delayed surgery
- Minimally invasive surgery
Starting in April, approximately one month before the Ethicon stapler recall, Ethicon themselves distributed notifications to their customers with instructions regarding the soon-to-be-recalled product. These groups included health care facilities, distributors, and third-party customers. Following the Ethicon stapler recall’s announcement, the FDA has made public those instructions. They read as follows:
- Examine inventory to determine if recipients have product subject to this recall on hand
- Quarantine affected product
- Remove the product subject to this recall and communicate the issue to relevant operating room or materials management personnel
- Return unused impacted Intraluminal Staplers subject to this recall that are in inventory
Facilities were also informed that they could receive a replacement for the recalled product as long as the product was returned by June 30, 2019. Additionally, Ethicon stated that distributors do not need to contact end customers regarding the recall. Ethicon also stated that it will directly communicate with customers about this recall at a later date.
Receiving Compensation Following The Ethicon Stapler Recall
With the Ethicon stapler recall in full swing, the FDA and Ethicon should soon be able to contain and dispose of the faulty products before they can do more harm. This is a significant accomplishment for consumer safety, but it cannot do anything to undo the past.
Many patients have been treated with intraluminal staplers from Ethicon before the Ethicon stapler recall occurred, and those people may have experienced complications and injury since March 2018. If you or a loved one are such a person then you need the best representation in a court of law to get the compensation you deserve. Parker Waichman is that representation.
At Parker Waichman LLP, teams of trial lawyers are prepared to fight for your cause to earn you the compensation that you deserve. Contact Parker Waichman today for a free consultation and let us help you on your journey back to normal.