Surgical staples are used by surgeons to close an incision after surgery. They are used as an option to stitches or sutures. Not all staples will dissolve as your wound or incision heals. The non-absorbable staples require special care and have to be removed by a doctor once the wound or incision heals.
How Long Do Staples Stay in Place?
In many cases, the staples used to close an incision after a surgical procedure remains in the patient for up to 21 days. It depends on where they are placed and how large the incision was also the direction it was made to determine exactly how long they remain in place. Another factor in determining how long the staple will remain is what type of surgery was done, and how complex the incision was or the severity of the wound. Other considerations to make would be how well the area is healing, where the staples have been used.
When staples are used in a C-section, they close a low transverse incision made horizontally across the body. These staples are generally able to be removed after three to four days. If staples are used to close a vertical incision, they are typically not removed for seven to ten days.
A doctor will examine the area and look for several indicators the staples are ready to be removed:
- There are no fluids, blood drainage from the area or pus surrounding the incision
- There are no signs of infection
- The area appears to have healed enough that the staples are no longer necessary to keep the wound closed
Can Patients Remove Their Own Staples?
Patients should never remove surgical staples. A licensed medical professional has to remove these devices to ensure they are taken out safely and do not cause medical complications.
- How Staples are Removed
Surgical staples are made of stainless steel wire and have the strength to keep a wound closed. There are times because of the wound’s location; the staples are not an option as they have to be placed far enough away from organs and structures. The cosmetic outcome is not always as desirable as a suture line, but they are stronger, quicker to insert, and easier to remove.
A sterile technique is used to remove the staples and a staple extractor. Before the staples are taken out, an order to remove them and specific directions for their removal must be issued. The medical professional removing the staples have to examine the wound before taking the staples out to make sure the wound has adequately healed. The staples are typically taken out by removing every other one initially. There are eighteen steps a healthcare professional should follow in the staple removal process:
- Confirm the doctor’s orders and explain to the patient how the procedure will work
- Gather all appropriate supplies within reach
- Place the patient in an appropriate position to reach the staples and provide them privacy
- Complete hand hygiene by thoroughly washing hands
- Create a sterile field and make sure all equipment is near, including staple extractor
- Remove the dressing over the wound and exam area
- Apply the appropriate non-sterile gloves
- Clean the incision area according to the doctor’s order or agency policy
- Beginning with every other staple, place the bottom tip of the staple remover beneath the staple. Close the handle and gently move the staple side to side to remove.
- When you can see both ends of the staple, move it away from the skin, and place the staple on a sterile gauze.
- Continue this process to take out every second staple to the end of the incision line
- Place Steri-Strips on the location of every removed staple.
- Remove remaining staples, and follow up with Steri-Strips on these locations
- Apply sterile dressing on the area or leave exposed to air if the area will not be irritated by clothing. The doctor should have left instructions as to the need for dressing or not.
- Position the patient, so they are comfortable and make sure they are not experiencing any pain.
- Provide instructions to the patient on how to bath and inspect the wound. Show them how to reapply Steri-Strips.
- Discard of supplies according to agency policy for biohazard materials.
- Perform a second-hand hygiene and document procedure.
Possible Complications Removing Surgical Staples
Some complications can occur when removing staples from a patient. The length of time the staples have been in place plays a significant role in how easily they will come out. Wound dehiscence is another:
- Wound dehiscence is a complication occurring in a wound where the edges no longer meet. This occurrence is also called wound separation. During a healthy healing process, a wound will have edges that come together neatly and are then held in place with surgical staples, sutures, or another closure method. The wound is supposed to fill with granulating tissue as the incision heals, which will become stronger over time as part of the healing process. Dehiscence can occur in the first couple of weeks after surgery when the wound is fresh. It can be mild where only a small area pulls apart to leave a gap in the incision. Dehiscence can also happen if a surgical staple comes free or by something as simple as a cough or sneeze. Severe cases of dehiscence can cause surgical staples to give way and allow the entire incision to reopen completely.
Multiple factors can place certain patients at a higher risk for wound dehiscence:
- Age plays a factor in those over 75 years old
- Use of steroids
- Tobacco use
- Chemotherapy or radiotherapy treatments
When wound dehiscence occurs, the medical professional will stop removing the staples and notify the doctor. The doctor will have to examine the area and determine the cause of the condition to determine the medical attention needed to correct.
Why Are Surgical Staples Used?
A surgical staple is used when an incision or wound is too large or complex to close with a traditional stitch. Surgical staples can decrease the time to complete surgery and cause less pain.
Surgical staples are often stronger, quicker, and simpler to use when a wound or incision is large, and are often used after major surgery. Doctors use the skin stapler to quickly close long skin wounds or cuts that are in hard to reach areas. Some staples dissolve in your body, and others are external and have to be removed by medical professionals.
The benefits of using staples are to allow your doctor to close a wound with minimal damage quickly. The surgical staple is also easier to take out than stitches. The absorbable staples present a lower risk of infection, and wounds heal better and leave fewer issues with scarring.
Risks Involving Surgical Staples
The FDA (Food and Drug Administration) had issued a warning in a letter to healthcare professionals in March of 2019 to alert them of the dangers associated with the use of surgical staplers being used for internal purposes. The implantable surgical staples being used with staplers that are standard devices during surgical procedures have risks associated with their use. In the letter, the FDA provided recommendations to help healthcare professionals reduce risks related to the surgical stapler device.
The surgical stapler and staples are used in a wide range of surgical applications such as gastrointestinal, thoracic, and gynecologic surgeries. During these procedures, part of an organ is removed, and others are cut through including tissues. This procedure is done to create connections between structures. The surgical stapler and staples facilitate these surgeries and help to shorten the time needed to complete the process than it would take if suturing were performed.
Until recently, the surgical stapler was regulated as a Class I medical device. It did not require premarket submission to the Food and Drug Administration. The implantable surgical staples are classified as Class II and require premarket review.
- Class I medical devices present minimal health risks to users and are often simple in design. Examples of a Class I device include elastic bandages or enema kits. These medical devices are exempt from the regulatory process. As an ‘exempt’ device, FDA clearance is not required prior to marketing the device in the United States. The manufacturer does, however, have to register their establishment and list the generic product with the agency.
- Class II medical devices have a moderate to high risk for patients. Examples of devices under this class include some pregnancy tests and power wheelchairs. Most medical devices fall under this class.
The FDA has issued communications previously about the risks associated with surgical staples and staplers and continues to assess MDRs (medical device reports) filed. Their analysis showed that from January 2011 through March 2018, there were more than 40,000 medical device reports received on the surgical staples and staplers being used internally. These reports included more than 350 deaths and more than 9,000 serious injuries. These reports also indicated that there had been more than 32,000 malfunctions with these devices.
One of the most common problems reported is an opening of the staple line. There are also reports of malformation of the staples, failure of the stapler to fire, difficulty in getting the stapler to fire, and staples being misapplied. Misapplied staples included being applied to the wrong tissue, or applying the incorrect size to a tissue.
When surgical staples or staplers malfunction or are misused, it can result in longer surgical times or additional surgical interventions. These issues can lead to complications such as sepsis, bleeding, risk of cancer recurrence, tearing of the internal organs or tissues, and even death.
The FDA's reminder in their March communication was to advise healthcare providers to review their labeling instructions for using surgical staplers and staples. Providers were reminded to study how to choose the appropriate staple size to match the patient’s tissue type and thickness before taking these devices into surgery. The letter also contained suggestions to providers on using alternative options for the surgical staples if the patient’s tissue were prone to bleeding, swollen or necrotic. The letter contained information on how to handle device malfunctions and to recognize what they were as well.
Patients need to understand that when surgical staples and staplers are used appropriately, they are beneficial as surgical tools. These devices are used in various types of surgical procedures and allow surgeons to perform less invasive operations and also reduce postoperative pain. The surgical staples also shorten your recovery time. The purpose of the FDA's letter to healthcare providers was to remind them of how important it is to select appropriately when using surgical staples and staplers to mitigate the risk to patients.
The FDA will be holding a public meeting to discuss whether the current path for manufacturers of surgical staplers is appropriate or not. There will be a comprehensive analysis of all medical device reports received regarding the surgical staples and staplers. The panel at this public meeting will offer input to the FDA on whether or not it should reclassify the surgical stapler from Class I to Class II so the agency can establish special control over the device. (*As of April 2019, the FDA has reclassified the surgical stapler as a Class II medical device.)
Risks Involved with Surgical Staples for Orthopedic Surgery
A study conducted on using metal surgical staples to close wounds after orthopedic surgery (surgery involving the joints) showed there is a greater risk of infection using these staples over the traditional nylon sutures.
Surgeons have been advised they should reconsider their technique of using surgical staples to close wounds from knee and hip surgeries until more research can be conducted to confirm these findings.
A wound complication is the primary source of illness following hip and knee surgeries, and are more likely to extend a patient’s stay in the hospital. These complications can also lead to readmission into the hospital to address the illness. There was also a link established between the deep infection and superficial wound infection when using surgical staples.
Orthopedic surgeons typically use both nylon sutures and metallic surgical staples to close a wound. It is regarded as a quicker procedure to use the staples and much easier than using sutures. The surgical staples; however, are more likely to cause an infection in the wound area and are also more expensive.
The optimal method to reclose skin remains unclear. It has shown in hip surgeries; there is a four times greater risk of developing an infection with the use of surgical staples than the suture closure. There was not; however, any significant difference between surgical staples and sutures in the development of discharge, dehiscence, inflammation, allergic reaction, or necrosis.
Lawsuits Filed Against Surgical Staples
In May of 2019, the FDA issued a Class 1 recall for Ethicon Endo-Surgery Curved Intraluminal Stapler as it has a high rate of failures and complications during surgeries. These staplers are commonly used in:
- Endo-related surgeries
- Gastrointestinal surgery
- Bariatric surgery
- Colorectal cancer surgery
- And others
A Class 1 recall by the FDA is for a situation where reasonable probability exists that the exposure or use of a product can cause death or adverse severe health conditions. They have recalled more than 92,000 staplers, and the reports of serious illnesses are mounting.
The staplers were reportedly misfiring staples during surgery and causing severe damage instead of repairing the organs they were intended to close. The device was also producing malformed staples that were responsible for serious injuries to patients.
Injuries sustained by patients from the malformed surgical staples include:
- A need for antibiotics
- Additional surgeries
- Internal bleeding
- A leak in the closure
- The need for a permanent ostomy bag
- Life-long digestive issues
- A need for further imaging studies
- Life-long nutritional deficiencies
There have been numerous lawsuits filed by those who have been hurt by the malfunctioning stapler. Lawsuits are partially malpractice claims against the doctor and hospital involved with the surgical staple procedure, and partly as product liability claims against the manufacturer of the surgical stapler.
The manufacturers have attempted to lay blame for the malfunction on the surgeons. They have claimed the surgeons are negligent for the misfiring of the stapler. Victims of the malfunctioning surgical staples are looking to receive compensatory damages to cover their costs and losses. Some of the damages being sought are for:
- Mental suffering and anguish
- Past and future medical expenses
- Physical pain
- Lost wages and professional repercussions the injury caused when the patient had to spend time recovering from damages
- Future inability to earn a living because of the damage or injuries sustained
How Do I Know If My Surgeon Used the Recalled Surgical Staples
It is quite possible that your surgeon was not aware whether or not staples became malformed. Surgeons who reported the misfiring issues were able to identify malfunction due to the noise that occurred when the device did not work correctly.
Most times, a surgeon will see if the stapling procedure went wrong as there will be visible signs such as perforations or tears immediately. However, other times they will only know if something went wrong after you experience health complications. When they perform a post-surgery exam, only then will they be able to determine the staples could be the cause of your illness.
Medical device manufacturers are subject to strict guidelines under FDA rules. These rules are put into place, so manufacturers of medical devices conduct extensive research, testing, and clinical trials before they are allowed to be used in medical procedures. The results of this testing give doctors the ability to make informed decisions as to which brand of surgical staples are the best based on the safety data from the trials.
Ethicon and a Mass Tort
A mass tort involves a large number of people or patients often within the same geographic area who are typically smaller groups than found with a class action suit. In a mass tort, even though these represent a large group of individuals, everyone is treated as a separate individual. As an individual, each plaintiff proves specific facts, including how they were injured.
A mass tort can be used when each plaintiff within the group has slightly different circumstances, but they are all related to one or several defendants. The mass tort is used over a class action suit when it is established the factual situations between the different plaintiffs is varying and outweighs the common issues necessary for a class action. Three distinct characteristics set mass torts apart from other legal lawsuits:
- They involve the participation of large volumes of claims all regarding a sole product or device
- The underlying facts in dispute are similar or uniform across all cases
- Different claims in mass torts have independence in value
A mass tort is typically filed when defective products or drugs injure patients or consumers on a large scale. A mass tort lawsuit generally is more complex than class-action lawsuits as they do not follow the standard pattern or legal procedure. These cases can be heard in either state or federal courts.
Mass torts are part of new and developing tort litigation. They stem from advances in modern technology. The mass tort addresses parties that are injured similarly by a single product, such as Ethicon Endo-Surgery Curved Intraluminal Stapler. The mass tort intends to allow all injured patients who have injuries that have occurred similarly to have their collective claims tried concurrently. This form of litigation benefits all as it is more efficient and economical.
Find a Mass Tort Against Ethicon Surgical Stapler Near Me?
There are extensive and life-altering damages and injuries being sustained by the Ethicon surgical stapler. If you are a victim of this device call Consumer Alert Now at 800-511-0747 today and learn about the compensation that you deserve. Thousands like you are suffering from the malfunction of this medical device, and like you, they need to seek restitution against this manufacturer. We understand the difficulty this device has caused in your life and want to ensure you receive as much justice as possible.