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If you’ve had surgery in the past few years, surgical staplers may have been used as part of the procedure. While this product has a helpful purpose in surgery and recovery, it can lead to complications. Serious risks are associated with this procedure and a surgical stapler lawsuit has been filed by personal injury lawyers for those who have been injured by the staples.
What are Surgical Staplers?
The surgical stapler is a specialized device that is often used in surgery instead of the traditional sutures to close wounds or connect tissues, such as with the lungs or bowels. The rise in popularity of staples comes from the reduced risk for inflammation at the site of the wound. It can also reduce the time required to close the wound and the width of the wound after closing.
Just like with sutures, staples can be used internally or externally. Numerous different staple sizes and designs exist for various uses. For example, some may be straight, while others may be curved. Some staples are even circular, which are often used in bowel resections or esophagogastric surgery. They may be used for hip or neck injuries, with cardiac procedures and cosmetic surgery, among many other procedures. You can find surgeons in almost every city and county that use this device as a replacement for stitches.
Staplers are most known in a procedure called stomach stapling, which is often recommended for weight loss. Staples for internal procedures may be dissolvable while those for external procedures may be removable. Those made of titanium do not dissolve, but they also don’t interfere with MRI scanners. Plastic staples are often chosen for people who have allergies to metal and can reduce the appearance of scars. Another type of staple is the polyactide-polyglycolide copolymer, which is an absorbable staple often used in plastic surgery.
The staplers used to apply the staples may be either disposable or reusable. They are designed for the specific kind of staple needed and look similar to a construction stapler.
Removable staples cannot be removed until the wound has healed sufficiently. This may be anywhere from three or four days to three weeks or longer. They must be removed by a medical professional with a special staple remover.
According to news from the Global Surgical Staplers Market, the market for surgical staplers is expected to grow. It is anticipated to exceed $4.50 billion by 2024 with several major manufacturers involved.
Risks with Surgical Staples
While staples have proven to be a safe alternative to sutures or stitches, they do come with some risk. The main risk is of infection around the wound area if bacteria gets into the wound or proper care is not given. If the staples are placed improperly due to negligence or accidents, the wound may not heal correctly or close completely, which is another risk.
Some patients have an allergic reaction to the materials which the staples are made of. If the staples are removed too early, the wound may reopen. These are all risks which can be avoided. If a person experiences new pain around the wound or bleeding, redness or swelling, they need medical attention right away. If the area around the staples changes appearance or size, it may be cause for concern.
FDA Warning About Surgical Staplers
The Food and Drug Administration (FDA) has expressed growing concern about the increasing number of reports of adverse issues in the use of surgical staplers. In fact, it created a letter to health care providers on March 8, 2019 to provide additional recommendations for patient safety.
According to the letter from the FDA, the organization conducted an analysis on the safety of the surgical stapler. Findings showed that from January 1, 2011 to March 31, 2018 more than 41,000 reports were received on these devices.
Included in the reports were the following incidents:
- More than 32,000 malfunctions
- More than 9,000 serious injuries
- 366 deaths
According to the FDA, the main instances for these reports come from internal stapling.
Common problems reported were opening of the staple line and staples that were malformed. Some staplers misfired or were difficult to fire and some even failed to fire the staple. Others applied staples to the wrong tissue or used the wrong size of staple for the tissue.
The FDA also listed common complications from these reports in the letter, which included bleeding, sepsis, formation of fistula and tearing of internal organs and tissues. There is also an increased risk of cancer recurrence and a risk of death.
Recommendations from the FDA
In the letter, the FDA provided several recommendations for medical personnel to follow if they were using staplers. Among the list of recommendations, it included the following:
- Keep a range of staple sizes available and use the appropriate size of cartridge based on the thickness of the tissue and type of tissue
- Use a different size staple if the handle of the stapler is difficult to squeeze
- Be aware that color schemes are not the same between manufacturers
- Consider a different option if the tissue of the patient is swollen, tears easily or bleeds when palpated
- Avoid using staples on large blood vessels or clamping the stapler on delicate tissue
The FDA has plans to hold a meeting open to the public in 2019 to determine if classification of surgical staplers needs to change from Class I to Class II medical devices. This would be a significant change for the protection of patients. With Class I medical devices, they do not need to be submitted to the FDA before going to market.
Class II medical devices must be reviewed by the FDA before going to market. The FDA can also establish specific controls to reduce known risks of the devices and determine product liability for any errors or failure to operate correctly.
Victims of Surgical Stapler Malfunctions
Anyone who has experienced an adverse event to the use of surgical staplers should report the situation to MedWatch, which is the Safety Information and Adverse Event Reporting program of the FDA. Adverse events with surgical staplers are a growing problem as this method of repair is becoming more popular. In fact, several medical malpractice lawsuits have already been filed and awarded. For instance, the jury in a trial in 2015 awarded almost $80 million in an injury lawsuit against Ethicon, the manufacturer of the defective device. The stapler malfunctioned when the patient underwent a procedure, causing severe damage to the bowel and led to the need for a colostomy bag and both internal and external scarring for the affected woman.
Ethicon is a subsidiary of Johnson & Johnson and one of the primary manufacturers of the device. However, other companies also manufacture these devices, including Covidien, PLC. This manufacturer had to recall defective surgical staples in 2012 when serious injuries and three deaths resulted after thoracic and neck surgery involving the use of staples.
The reasons for the issues with surgical staplers can vary. In some cases, the device is defective. This often puts the liability on the manufacturer. In other situations, the surgeon may use the wrong size staple or choose stapling when suturing or stitches is a better and safer choice. Many times, the manufacturer promotes the use of a stapler for surgeries where it is not medically advisable. Malpractice attorneys can help you determine who is liable or who was negligent.
The damage from the staples is not always immediately known. The patient may feel fine for a few days and be able to go home from the hospital. It might only be afterwards that they begin to experience the side effects, such as pain, infection and vomiting. The doctor must determine if the symptoms are in response to the injury or illness or to the staples.
While staples can be used in many kinds of surgeries and procedures, those with the most adverse results come from situations which involve sensitive organs or with organs that can have dangerous leakage. Some of the surgeries which have resulted in lawsuits for surgical staples include the following:
- Neck/thoracic surgery
- Heart surgery
- Lung surgery
- Gastric bypass surgery or bariatric surgery
Find Out If You Can Get Help
If you’ve had a surgery involving surgical staplers and have had adverse effects from the staples, you may be eligible to receive compensation for your losses. You may want to seek out an experienced surgical stapler lawsuit attorney who can help you determine your next steps and build a case. They can provide legal advice for your specific situation, but you may be able to receive damages for the cost of medical care for the past and future as well as a settlement for pain and suffering.
If you have a loved one who died as a result of a procedure using these surgical staples and an infection that followed, you should also contact a personal injury law firm who can help you. You may be eligible to file a wrongful death lawsuit to receive damages for the loss of your loved one and the resulting consequences.
Find an attorney in the practice areas of personal injury and defective medical products who can represent you. They may also handle brain injury and birth injury cases as well as other types of personal injury cases. Call them toll free on the phone or contact them through the website to find out if you are eligible for compensation for your injury. They will assist you with building a strong case and represent you in court as you strive to get a verdict that awards damages to cover your expenses and losses.
Both medical device manufacturers and medical personnel may be held responsible for the decisions they make that adversely affect the quality of a patient’s life. Find out if you have rights and if your situation qualifies for filing a lawsuit and compensation for the losses you have received because of surgical staplers. You can call an attorney today for a free consultation to find out about your options and how you can get the help you need.