How You Can Receive Full Compensation For a Surgical Stapler Injuries or Wrongful Death Claim
Consumer Alert: The FDA Has Received Over 41,000 Adverse Event Reports Linked to Surgical Staplers and Implantable Staples
Have you or a loved one suffered post-surgical site complications with implantable, surgical staples?
If so, you may be entitled to recover financial compensation. Parker Waichman LLP is reviewing post-surgical complications such as severe and sometimes fatal injuries linked to malfunctioning and defective surgical staples. If you believe that your injuries, the injuries of a family member or the loss of a loved one is connected to post-surgical complications with surgical staples, call our law firm at 1-800-YOURLAWYER (800-968-7529) for your free, no-obligation medical/legal case evaluation.
What are Surgical Staples and Staplers?
Surgical staplers are categorized by the United States Food & Drug Administration as a “medical device.” Surgical staples and staplers are used both internally and externally during a surgical procedure, to close wounds or surgical sites where the tissues are under high tension. The advantages of using surgical staples over surgical sutures are:
- Surgical staples close a wound much faster.
- Surgical staples are stainless steel and are less likely to cause a tissue reaction.
- Surgical staples have a history of lower infection risks.
- Surgical staples are much more durable.
How are Implantable Staples and Surgical Staplers Used?
Surgical staplers containing implantable surgical staples are often used in gynecologic, gastrointestinal, thoracic surgeries. Implantable surgical staples are also used in many other surgical operations and procedures such as:
- Resection of certain tissues or organs.
- Transection procedures on organs or tissue.
- Anastomoses procedures between tissue structures.
Are There Any Safety Concern With Surgical Staplers?
Yes. On March 8, 2019, the U.S. Food and Drug Administration (FDA) issued a warning letter to healthcare professionals detailing serious complications and injury risks linked with surgical staplers and staples. In the letter, the FDA stated that it is “concerned by increasing number of adverse events associated with surgical staplers and staples for internal use. The FDA letter also provided healthcare providers with detailed recommendations and instructions to protect their patients and “reduce the risk of adverse events associated” with the surgical staplers and staples. The FDA letter also contained new recommendations and the actions to be implemented by the FDA which will improve the safety and the safe use of surgical staplers.
Another potential issue arose on April 6, 2019, when Johnson & Johnson’s subsidiary Ethicon released a warning to consumers in the Middle East, Africa, and Europe about the dangers of their intraluminal staplers. According to their report, the staples could be malformed or the washers could have been uncut. For more information about the risks of Ethicon’s intraluminal stapler’s, see our coverage of the issue here.
On May 16, 2019, the U.S. Food and Drug Administration issued a Class I recall for Ethicon’s Circular surgical staplers because of the staplers’ failure to fire and correctly form staples when surgeons are repairing certain gastrointestinal surgeries. The FDA classified the recall as Class I. A Class I recall is the highest recall level used by the FDA. A Class I recall signifies that the defects found in the recalled medical device could cause serious personal injury or death.
According to the FDA announcement, Ethicon’s surgical staplers are used by surgeons to create a connection between structures in the gastrointestinal tract after surgery. The FDA said that Ethicon performed a thorough investigation into consumer complaints the company received from surgeons as well as products returned to the company as defective. Ethicon learned through its examination that uncut washers found in the stapler and improperly formed staples signify that the device was not firing correctly.
Cut washers are significant to the surgeon. When the device is working properly, the surgeon will hear a crunch and feel the device cut the washer, thereby signifying the staple line is intact. Misfired staples, on the other hand, can cause a tremendous amount of collateral health issues. Malformed staples can lead to infection, sepsis, death, bleeding, a permanent colostomy bag, bleeding, leakage, nutritional and digestive issues, as well as the need for additional surgeries. Additional surgeries can lead to additional health complications for the patient.
Ethicon became aware of the defect after two patients sustained severe injuries during surgery. The misfiring stapler forced the resection of the lower rectum in one patient and the middle rectum in another patient even though both patients had upper rectum rescission surgery.
Any patient who has recently had gastrointestinal surgery, including patients who had bariatric surgery or surgery to treat colon cancer are at risk for having difficulties and should consult their surgeon.
Johnson & Johnson Issues Recall of Surgical Tool Following Patient Death and Reports of Serious Injuries
Per bloomberg.com, Johnson & Johnson has recalled its ECHELON FLEX™ ENDOPATH® Staplers following reports that seven patients were injured and one died, per the United States Food and Drug Administration (FDA).
The devices, made by Johnson & Johnson’s Ethicon unit, is used to cut and staple tissue together at the same time during surgery. The issues with the staplers are associated with a part of the device that does not properly close surgical incisions, per the FDA. This has led to bleeding, leakage, and revision surgeries to repair the original incision site.
The FDA, a result of the reported adverse effects associated with the use of the surgical staplers, has issued a Class I recall, which is the most serious category of recalls that are only declared when there is a high likelihood of injuries or death. The FDA did not indicate that the injuries and death were associated with the malfunctioning of the staplers.
Johnson & Johnson has faced thousands of lawsuits claiming that their products, including drugs, baby powder, surgical devices, and opioids caused patients to be harmed. In response, the company has asserted that its products are safe, despite the claims to the contrary. Notwithstanding, the ever-increasing amount of lawsuits filed against Johnson & Johnson has begun to worry investors. In fact, Johnson & Johnson’s shares recently decreased by 0.08%.
The recall applies to 8,256 staplers that were distributed in August and September of this year. When contacted, Johnson & Johnson did not respond to a request for comment.
Surgical Staplers and Staples Face Reclassification and Recall Following FDA Recommendations
Surgical staplers and staples are used in surgeries to close wounds externally (typically on the head or torso), and to manipulate tissue and organs internally. The various uses of surgical staplers and staples have led to multiple patient injuries and deaths. Surgical staplers and staples are medical devices that are not currently subject to any standards that would help to ensure patient safety. As such, the United States Food and Drug Administration (FDA) wants to reclassify surgical staplers and staples from being Class I medical devices to Class II medical devices, a category that requires a premarket submission to the FDA.
FDA Letter to Doctors
On March 8, 2019, the FDA sent a letter to doctors and other healthcare providers warning of the risks associated with the use of surgical staplers and staples. The letter identified the numerous ways in which patients have sustained injuries and death, stating that the FDA has received more than 41,000 medical device reports. The reports identified the following outcomes with the use of surgical staplers and staples:
- 366 deaths;
- More than 9,000 serious injuries (including, among others, sepsis, bleeding, fistula formation, tearing of internal tissues and organs, and increased risk of cancer recurrence); and
- More than 32,000 malfunctions.
Adverse events which resulted in injuries and death include, but may not be limited to, the following:
- Failure of the stapler to fire the staple;
- Misapplication of staples (for example, when the user applies staples to the wrong tissue or using the wrong size staples); and
- Difficulty in firing the staples.
The FDA’s review of adverse event data associated with surgical staplers and staples demonstrates that patients are subject to risks they may not know about, placing themselves in harm’s way.
The FDA’s Push to Reclassify Surgical Staplers and Staples from Class I to Class II
To crackdown on dangerous and potentially fatal outcomes from faulty surgical staplers and staples, the FDA plans to reclassify the surgical staplers and staples from Class I to Class II. As a Class I medical device, surgical staplers and staples are not subject to heightened scrutiny, given that a premarket submission is not required for Class I medical devices.
Class II medical devices, on the other hand, must go through the premarket submission process. Such devices are subject to FDA regulations that would require manufacturers to take steps to protect patient safety. The FDA’s executive summary, which was presented at a meeting of the General and Plastic Surgery Devices Panel on May 30, 2019, discusses the plan to require manufacturers to go through the premarket submission process. If manufacturers are required to submit an application to the FDA before selling a medical device, there may be a significant amount of surgical stapler and staple recalls in the coming months.
Ethicon Recalls Circular Staplers
Ethicon, Inc. manufactures a broad range of medical devices, including surgical staplers and staples. On April 11, 2019, Ethicon recalled its circular staplers after receiving reports of stapler misfirings. The medical device manufacturer received reports of two patient injuries related to misfirings. However, given that many injuries go unreported, the actual number of injuries could be much higher.
The FDA has identified the Ethicon recall as “Class I,” which means that the staplers and staples have the potential to cause serious injuries or death. The FDA has provided the following recall information for patients and healthcare providers:
- Product Names: 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 (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 9, 2019
- Total Number of Devices Subject to Recall: 92,496
The Ethicon recall may only be the beginning. There are numerous companies that manufacture surgical staplers and staples. As such, as patients become aware of the Ethicon recall, they may learn that any injuries they suffered because of surgical staplers used in a medical procedure could be the result of defective and dangerous medical devices.
What Injuries are Linked to Surgical Staplers & Implantable Staples?
Surgical Staples Misfiring and Implantable Staples Malformation Attorney Lawsuit
The FDA stated that because surgical staplers and implantable staples are packaged together as a system, the FDA would analyze medical device adverse event reports for both implantable staples and surgical staplers to formulate a comprehensive safety profile for these medical devices and that is why we have Surgical Staples Misfiring and Implantable Staples Malformation Attorney Lawsuit. The FDA discovered over 41,000 distinct adverse event reports spanning January 1, 2011, until March 31, 2018. Although the FDA is continuing to review new medical device adverse event reports, the reports are alarming:
- 366 fatalities,
- 9,000+ severe injuries, and
- 32,000+ malfunctions.
The FDA believes that a majority of the adverse event reports are attributed to internal surgical staplers because “proper staple formation is largely contingent on proper function and use of the stapler.”
The Most Common Problems Reported to the FDA
The FDA stated in their initial analysis that the most common issues reported in this medical device’s adverse event report include:
- Malfunctioning staplers resulting in misfiring of the staples,
- Malformation of the implantable staples,
- Opening of the staple line,
- Stapler failing to fire,
- Difficulty in firing the stapler, and
- Misapplied surgical staples. (e.g., incorrect surgical staple size or operator errors).
Stapler and/or Staple Complications & Unplanned Surgical Interventions
The FDA adverse event report analysis also discovered and reported to healthcare professionals that “stapler and/or staple malfunctions or misuse may result in prolonged surgical procedures or unplanned, additional surgical interventions, which may lead to other complications,” some of which are life-threatening in nature, such as:
- Internal or external bleeding,
- fistula formations,
- increased risk of cancer recurrence,
- internal tissue tears,
- organs tearing, and
Do I Have Ground to File a Surgical Staple or Stapler Lawsuit Against the Manufacturer or Surgeon?
If you or someone you love has suffered the aforementioned complications resulting in injuries or death, call our law firm promptly to discuss your legal matter. Each state has specific limits on the amount of time that you are permitted to bring your claim to recover financial compensation for your pain, suffering, medical expenses and losses.
Contact the caring and experienced attorneys at Parker Waichman LLP to learn about the compensation you may be entitled to recover and the applicable time limitations on your surgical stapler injury lawsuit or wrongful death action.
If we are able to represent you, we will immediately begin working on your case, determine the applicable statute of limitations, and preserve all pertinent evidence necessary to bring your claim. If you believe that you or your loved one has a legal cause of action, contact our law office today at 1-800-YOURLAWYER (800-968-7529) for your free, no-obligation medical/legal case evaluation.
Why Choose Parker Waichman LLP for Your Case?
Parker Waichman LLP is a national defective medical device law firm with a stellar reputation for winning large jury awards and verdicts against medical device manufacturers. Medical device liability cases are extremely complex and are rigorously defended by highly skilled corporate counsel with sizeable budgets for the litigation defense. Parker Waichman LLP has decades of trial experience and has successfully recovered over $2 billion for injury victims and their families. The bottom line is this: we know how to win.
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The legal professionals at Parker Waichman LLP are extremely proud of the results that we have secured for our clients. There are only a few plaintiff law firms who have recovered over $2 billion in awards, settlement awards and jury verdicts.
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Contact Parker Waichman LLP for Your Free Case Review – Your Time Limited By Law
At Parker Waichman LLP, our medical device liability attorneys take on the most challenging plaintiff cases and we intensely advocate for our clients’ full monetary compensation. Parker Waichman LLP is fiercely dedicated to protecting your rights, and we have an outstanding reputation for superior results. If you or a loved one have received surgical staples and suffered post-surgical injuries or you lost a loved one due to complications, contact our firm right away to receive your free consultation. Simply use our Live Chat or call us today at 1-800-YOURLAWYER (1-800-968-7529) for your free Consultation with an experienced attorney from our firm.
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