Are Surgical Staples Safe?

Surgical staples are used in a variety of surgeries as a way of closing a wound. Staples are generally used as an alternative to stitches during complex surgeries when stitches would take too long or would not sufficiently close the opening. Over the years, surgical staples have generally been thought of as safe, however, recent developments have shown an increasing number of adverse reactions to the product. 

In 2019, studies conducted by the U.S. Food and Drug Administration (FDA) found that over 41,000 reports were made by patients who had received surgical staples between January 1, 2011, and March 31, 2018. During this time, 366 deaths were reported, along with many side effects and health problems caused by staples. Throughout 2019, the FDA issued recalls regarding surgical staplers and the staples they implanted due to ongoing concern with the product. 

This recall opened up surgical stapler manufacturers to lawsuits. If you or a loved one has suffered health problems due to surgical staples that were recalled by the FDA, then you may have the opportunity to recover compensation for your damages and should seek the assistance of a mass tort lawsuit attorney. When you are ready to take the next step to recover compensation for the damages suffered, please fill out this form on our website

Injuries Claimed in Surgical Staple Lawsuits

Lawsuits against surgical stapler manufacturers have claimed injuries that vary in their severity. While the injuries listed can be life-threatening, one of the difficulties with the current lawsuits is proving that surgical staples were the cause of the injuries. 

Since surgical staples are implanted during surgeries, the body is already at a greater risk for negative health effects. With that being said, some of the most common severe injuries listed in surgical staple lawsuits are:

  • Damaged internal organs
  • Sepsis
  • An abnormal connection that occurs between organs or tissues in the body
  • Bleeding

These complications are a risk of most surgeries, but with the recent FDA recall of surgical staplers produced by certain manufacturers, there is increasing evidence that staples could be the cause for many more of these types of complications than previously expected.

If you recently went through a surgery that involved surgical staples and you believe you are suffering from any of the above complications, then you should seek medical attention immediately. After your health has been monitored, you should seek the assistance of an attorney who can help you recover compensation for damages.

Manufacturers and Surgical Stapler Recalls

There are two main manufacturers of surgical staplers that have been listed in recalls over the past decade. The largest number of recalled staplers was from 2019 when Medtronic recalled 3,113,280 staplers. In 2018, Medtronic recalled another 171,271 staplers as a result of similar conditions being observed following surgery.

The other main manufacturer to issue a recall was Ethicon. In the past decade, the company has issued three separate recalls of four different products. In 2013, they recalled 57,540 ECHELON 60mm Endoscopic Linear Cutter Reloads Black, then in 2015, they recalled 6,744 Endopath Echelon Flex Powered Vascular Staplers with Advanced Placement Tip and White Reloads.

Most recently, Ethicon recalled 92,946 staplers in 2019. The staplers recalled consisted of two products, the Endo-Surgery Curved Intraluminal Stapler with Adjustable Height Staples and the Endo-Surgery Endoscopic Curved Intraluminal Stapler with Adjustable Height Staples. There are other manufacturers of surgical staplers, but they have not endured any major recalls at this moment.

What Manufacturing Defects Led to Recalls?

In the most recent recall from Ethicon, the reason listed was that two patients had portions of their rectums cut due to an error during the implanting of the staples. This description makes it seem as though the issue was because of surgeon error, but it looks likely that a manufacturing defect caused the problem.

In both recalls from Medtronics, the reason for the recall was a manufacturing defect. In both 2018 and 2019, it was determined that there were missing pieces of the surgical staplers that were affecting staple alignment. Because of the misalignment of the staples, patients were experiencing serious complications following surgery.

Both of these instances are very different from what was reported in 2013 and 2015 by Ethicon. During that time, the stapler manufacturer was seeing problems with both reloading and the proper amount of staples being used during surgery. These issues have not been mentioned in any of the more recent recalls. 

While these are the main reasons for the recalls, there is still more being uncovered about what other factors could be leading to surgical staplers producing at a lower level than expected. Because this is a relatively new problem, the amount of information known is less than is known about other problems. However, there is extensive research being done to figure out exactly what is causing such severe complications.

Role of the FDA in Making Surgical Staples Safe

Due to a lack of reporting by companies, the FDA was not made aware of a majority of surgical staple issues between 2011 and 2018. While manufacturers are required to report serious injuries and deaths to the FDA for their public database, this step was being disregarded by many. In fact, there was another database that was bypassing the FDA, which was listing numerous injuries that were occurring because of staples.

When the FDA was made aware of the secret database and the resulting injuries and deaths that were unreported, they immediately began to change their recommendations regarding surgical staples. In 2019, the FDA immediately made doctors and hospitals aware of the dangers surrounding surgical staples and issued guidance on how to properly use and implement them.

With the FDA aware of the problems that had been occurring for the majority of a decade, manufacturers had no choice but to recall products that were causing damaging side effects to patients.

Surgical Staples Lawsuits

Surgical staples lawsuits are still in their very early stages with individual lawsuits forming but no official mass tort or class action lawsuit filed yet. However, with the recall, and the increasing number of lawsuits that have followed, multi-district litigation will likely be filed soon. 

Even though there is no guarantee that mass tort or class action lawsuits will develop, that does not mean that you should not seek the assistance of an attorney if you believe you have suffered due to surgical staples. Filing an individual lawsuit against a major manufacturer can seem like a daunting task, but you should not be discouraged. There have been settlements in the past for individual cases that have landed plaintiffs millions of dollars in compensation.

With more information coming out and the recent FDA recalls, a class action lawsuit or mass tort lawsuit could be filed soon. If that happens, then you will be able to opt into the lawsuit even if you have already filed an individual suit. If you have suffered due to surgical staples, there is no benefit to waiting to seek the help of an attorney.

How to File for Surgical Staples Lawsuit

The first thing you need to do when you are ready to file a surgical staples lawsuit is to speak with an attorney. Explaining your situation to the lawyer and allowing them to explain your options to you will be the first step in what will likely be a multi-year process. 

After you have chosen the mass tort lawsuit attorney that you want to represent you, they will likely ask you for your medical records, so that they can review the dates that you received surgical staples, any health issues you had prior to that, and any complications you had following surgery. During this time, the attorney may discuss your situation with medical professionals to get the best understanding of the situation and how it fits with other lawsuits of the same kind.

Once your attorney believes that there is enough evidence for a lawsuit, one will be filed against the manufacturer of the surgical staples that impacted your life. By working with a lawyer, you ensure that you have a professional on your side who knows the legal process. This will take the guesswork out of the situation for you and make certain that you are correctly filing your lawsuit.

With so much still up in the air regarding surgical staple lawsuits, your lawyer will also be able to keep you informed of any class action or mass tort lawsuits that are filed against the manufacturers. Your lawyer will be able to give you the best advice on what you should do should any circumstances change. With an attorney, you will not have to do the research and stay up to date on your own.

How Much Can I Get from a Surgical Staples Lawsuit?

Lawsuits pertaining to surgical staples have resulted in millions of dollars being awarded to patients in individual cases. Every case is different, and yours will be different than others that have already been settled, but knowing how much others have settled for and their symptoms, can give you an idea of what your case may be worth.

The largest settlement in the history of surgical staples lawsuits came when a California jury awarded a former police officer nearly $80 million in compensation. However, in 2018, this total was reduced to $19.6 million as an appeals court cited a maximum for punitive damages. This settlement was awarded after the plaintiff suffered severe complications, pain and suffering, and lost wages. This case is almost certainly an outlier; however, it gives a good example of how much can be won.

How much you could get from your specific lawsuit depends on how your life is affected by the surgical staple malfunction. For instance, a person who undergoes surgery and suffers a life-threatening complication that requires more surgery and produces significant life changes that result in a loss of enjoyment will receive more than someone who suffers an infection that is cleared up with antibiotics.

But life-threatening complications are not the only way that you could receive compensation from a lawsuit. If surgical staples require you to have to spend more time in the hospital, then you could have your medical bills reimbursed. You could also sue for lost wages and lost earning capacity that you suffered as a result of complications.

Talk to a Surgical Staples Lawsuit Attorney

If you believe that surgical staples caused the complications that you are suffering from, then you should seek the assistance of an attorney. By speaking with a surgical staples lawsuit attorney, you will gain a better understanding of what you can sue for, how much you should expect to receive in compensation and other vital information that will ensure that you recover an optimal sum. 

In addition, your attorney will work closely with other experts, including medical doctors, so that you can rest and recover knowing that everything is being handled on your behalf. Like all cases are different, so are attorneys. Make sure that you find the right one for you. When you call to discuss your situation, ask questions. Speak to multiple law firms, so you can get a better understanding of how they can assist you. 

Finally, be sure that you are comfortable sharing very private details with the mass tort lawsuit lawyer you choose, as they will be reviewing private documents such as medical records. When you are ready to take the next step to recover compensation for the damages suffered due to recalled surgical staples, please fill out the form on our website