Can Surgical Staplers Cause Serious Injuries & Death?

During the past two years, the Food and Drug Administration (FDA) has issued news releases, recalls, guidelines and other materials regarding surgical and implantable staples. This has been in response to the very large number of medical device reports (MDRs) that were submitted to the FDA between January 1, 2011 and March 31, 2018. In fact, at least 41,000 MDRs were received by the FDA during that time period (some experts claim that number is far higher).

Numerous issues have been raised about the dangers posed to patients by both surgical and implantable staples. Unfortunately, too many patients are still suffering – and sometimes dying – due to the ongoing errors some doctors keep making while using faulty surgical staplers.

What follows is a closer look at why so many patients are still coming forward with serious injuries caused by staplers, the exact nature of the injuries these patients are suffering and what the FDA has been doing with all the medical device reports it’s been receiving. Information is also shared about why staplers are often used in place of sutures – and the types of surgeries that often require doctors to use surgical staplers.

What types of injuries do patients often suffer due to the use of defective staplers?

Depending on the exact nature of the surgery being performed, one or more of the following injuries have been reported. (Different types of staplers may cause unique injuries).

• Internal bleeding
• This life-threatening medical condition develops when an infection you already have suddenly spreads all throughout your body. Death can soon occur if immediate treatments aren’t successful.
• Organ damage
• Infections
• These involve abnormal connections between internal parts of the body. They are sometimes caused by surgical complications.
• Nutritional deficiencies that may become permanent
• Inflammation and pain near the incision or wound
• Digestive issues that may last the rest of the patient’s life
• Damage so great that the patient will require a permanent ostomy device
• An anastomotic leak after colon or rectal surgery

These and other physical damages may require new imaging studies, immediate antibiotic treatment – and even corrective surgeries. Depending on the extent of the condition, death can occur – and that can become more likely when several of these conditions develop simultaneously.

Unfortunately, the damage done by these staples may not actually be discovered in some cases until post-surgery, during follow-up visits that are scheduled in a surgeon’s office.

What is the exact cause of many of these injuries?

• Surgeons and other healthcare providers may choose to use the wrong type of stapler for your current needs.
• A stapler device may malfunction, causing a staple to become misshaped and dangerous
• Surgery time may be lengthened, leading to complications, especially after a staple is improperly put in place.
• A surgeon may apply a staple to the wrong tissues or organ
• The wrong size staple may be chosen for your surgery
• The improper application of a line of staples, causing a wound to leak
• When a patient’s tissues are swollen or inflamed – a doctor may still go ahead with the stapling process – even when s/he knows (or should have known) to consider alternative options

During which types of surgeries are staplers often used?

Staplers are used during many different types of surgeries, including those listed below.

• Urologic and gynecologic
• Thoracic
• When a patient has colorectal cancer
• Gastrointestinal problems are present
• An endo-related surgery is required

What types of losses can be covered if my surgical stapler lawsuit is successful?

• All past and future wages lost due to the injury
• Medical expenses – also past and future
• In some cases, loss of consortium
• All physical and mental pain and suffering. This also applies to what may be suffered during the rehabilitation process.
• In wrongful death cases, reasonable funeral expenses
• Punitive damages may be available, in limited cases

How many different companies make surgical staplers?

There are many companies that make these medical devices. However, most of them may not have recently issued any recalls. Here’s at least a partial list of these companies.

• Covidien
• Ethicon
• S. Surgical
• Johnston & Johnson
• 3M Corporation
• Stryker Medical
• Tyco Medical Group

Why do surgeons use staples instead of stitches? 

Fortunately, highly experienced and cautious surgeons will always consider the nature of your current medical needs before deciding whether to use adhesive tape, sutures (stitches), a special type of medical glue – or a surgical stapler. As is noted on the WebMD website, other factors also considered include your overall health, your age, the available medical supplies – and the doctor’s own level of experience.

A general overview of FDA surgical staple recalls since 2011

Obtaining accurate information about surgical stapler recalls has been difficult during the past decade. The reasons for this problem were finally discussed openly in a startling May 30, 2019 article published by Kaiser Health News. In this article entitled, “More Than Half of Surgical Stapler Malfunctions Went to Hidden FDA Database,” we’re told that more than 56,000 adverse medical device reports were apparently routed to a separate database of information that had not been previously shared with the public.

This is extremely troubling – especially given the obvious fact stated in that article that “surgical staplers have a unique ability to harm patients if they malfunction.” The article implies that instead of all malfunctioning medical devices being reported in the usual manner, a vast number of them (including those pertaining to surgical staplers) were placed in a somewhat secret, hidden database where they were simply labeled as “alternative summary” reports.

This unfortunate approach taken by the FDA appears to have kept American patients and consumers – and their surgeons — unaware of critical medical information that might have prevented many injuries and deaths.

After issuing a “Draft Guidance” in April 2019 that addressed the proper labeling of all surgical staplers, the FDA issued a recall in May covering Ethicon staplers (see below). These were commonly used during gastrointestinal surgeries. The following month, that designation was declared to be a “Class 1” recall – indicating that there was significant evidence that the product might cause serious injuries or even death. Here are two other documented recalls.

• May 16, 2019. The FDA recalled the Ethicon Endo-Surgery (Curved Intraluminal) Stapler (with adjustable height staples) and the Endo-Surgery Endoscopic Curved Intraluminal Stapler, also with staples of adjustable height.
• October 30, 2019. The FDA issued recalls for four separate yet related products, including the Echelon Flex 60 Endopath Stapler.

Given the problems connected with the “hidden database,” its quite likely that many other recalls should have been issued since 2011. (It appears that some companies, that may include Medtronic, may have recalled some of their surgical staplers during the past decade, even if formal FDA recalls did not occur).

As the information and evidence shared above indicates, regarding this article’s title, far too many serious injuries and deaths have occurred due to the continued use of malfunctioning surgical staplers.

If you (or a loved one) have recently suffered serious medical harm due to a doctor using surgical staples, you need to contact our New York City medical malpractice law firm. We will carefully investigate all the facts of your case and then fight hard to win the maximum compensation available. We are dedicated to helping every client try to recover for all lost wages, pain and suffering, medical expenses and other losses.