On March 8, 2019, the FDA sent a letter to health care providers warning them of potential safety risks associated with surgical staplers.  An analysis of surgical stapler medical device reports (MDRs) showed that between January 1, 2011, and March 31, 2018, the FDA received over 41,000 reports of problems with these devices, including 366 deaths, over 9,000 serious injuries, and over 32,000 malfunctions.

When a surgical stapler malfunctions, it can cause excessive bleeding, surgical complications, infections, need for additional or prolonged surgery, and even death.  Yet many of these reports were unavailable for review until recently, as the FDA allowed manufacturers to file them in an alternative database that was kept hidden from doctors and the general public.

The FDA is now putting an end to that hidden database, but meanwhile, many patients have suffered severe and sometimes fatal injuries because of faulty surgical staplers.  Chaffin Luhana’s medical device lawyers are investigating cases in which patients suffered serious injuries and/or death because of surgical stapler malfunctions.

What Are the Problems Associated with Surgical Staplers?

The FDA has received thousands of reports of surgical staplers malfunctioning and causing problems. Some of the problems related to the staplers themselves included:

• Misfiring or difficulty in firing—the stapler jams
• Firing with too much or too little force
• Sending the staple into the wrong place
• Failure to fire or accidental firing
• Misapplied staples (such as applying staples of the wrong size, often due to operator error)

In some cases, it’s the staple that malfunctions:

• The staple breaks during placement or afterward
• The staples aren’t shaped correctly—they are malformed
• The staple causes an allergic reaction
• The staple contains bacteria and causes an infection
• Metal or plastic from the stable gets into the bloodstream

In one instance reported by Kaiser Health News, a patient underwent liver surgery in Ohio when the surgical stapler his surgeon was using misfired, severing a vein.  The medical staff had to perform CPR for 22 minutes while surgeons rushed to stitch together the bleeding vein.  The patient went into a coma, and when he emerged he was unable to walk or regularly recognize his wife or son.

Other potential injuries caused by malfunctioning staplers include:

• Bleeding
• Sepsis
• Tearing of internal tissues and organs
• Fistula formation
• Increased risk of cancer recurrence
• Death

Some individual surgical stapler manufacturers have experienced problems with their devices in the past.  Ethicon, for example, a subsidiary of Johnson & Johnson, recalled over 92,000 of their Endo-Surgery Curved Intraluminal Staplers in April 2019 because of a risk of insufficient firing, which can compromise the integrity of the staple line.

The company confirmed that there were uncut washers in some of the staplers, which could create staple line failure.  Use of the defective products could cause death and serious injuries such as sepsis, bleeding, life-long digestive and nutritional issues, and leaks in incision closures, as well as the need for additional surgeries.

At the time of the recall, Ethicon was aware of serious injuries in two patients who were undergoing surgery for the upper rectum:

1. Misfiring of the stapler in one resulted in an additional resection of the middle rectum
2. Misfiring of the stapler resulted in resection in the lower rectum

FDA Hid Reports of Problems with Surgical Staplers for Years

Physicians and surgeons remained largely unaware of the extent of the problem, as they were relying on public records when making decisions about which devices to use because the device MDRs kept hidden.

In most cases, the FDA requires device makers to report to a public database (MAUDE) any injuries or device malfunctions they become aware of.  This database is then made available to doctors and the public, allowing medical professionals to learn about any issues that may affect patient care.

In March 2019, however, an investigative report by Kaiser Health News revealed that the FDA had allowed some medical device companies to file reports of injuries and malfunctions in a separate database that was kept hidden from public view and was available only to the FDA.

Since 2016, at least 1.1 million incidents— including serious injury and malfunction reports related to about 100 medical devices like surgical staplers—were filed in this alternative database.

The FDA started this program about 20 years ago allegedly to streamline and make more efficient the review of device reports.  Thus, they exempted some manufacturers from the standard reporting requirements, allowing them to shuffle reports into the hidden database.  Reports concerning problems with products like surgical staplers, cardiac defibrillators, pacemakers, and tooth implants were among those included in this database.

The problem was that the program was so obscure that most doctors were unaware of it.  Six top cardiologists interviewed for a CNN report said they weren’t aware of these exemptions.  Pittsburgh surgeon Dr. Douglas Kwazneski was also completely unaware of the FDA’s practice of granting exemptions to some manufacturers or of a hidden database, and told Kaiser Health News that it “seemed like a cover-up.”

In one instance, Dr. Kwazneski was conducting an appendectomy when his surgical stapler locked up.  He checked the FDA’s public database and didn’t find any reports of similar issues, so he asked his fellow surgeons and discovered that more than two-thirds of them had either personally experienced similar issues with their surgical staplers or were aware of a peer who did.

He went on to write an article for the journal Surgical Endoscopy detailing the results of a survey distributed to 124 medical program directors. Results showed:

• 86 percent reported personal or peer experience with a linear stapler not releasing or not firing after application
• 27 percent of respondents noted this problem occurred three or more times
• One-quarter of the respondents noted that the malfunction caused them to significantly alter their operative procedures
• 30 percent reported that they received no helpful feedback from the manufacturer despite contacting it

The FDA announced on June 21, 2019, its intention to shut down the alternative database, end the practice of giving some manufacturers exemptions, and open records to the public.  It also issued revocation letters to the manufacturers who still have exemptions and posted data from that hidden database online.

Meanwhile, the FDA is cracking down on surgical staplers and looking for new ways to protect patients.

FDA Reviewing Safety of Surgical Staplers

In April 2019, the FDA proposed reclassifying surgical staplers from Class I devices—which are considered to have a low to moderate risk to the patient—to Class II devices, which have a moderate to high risk to the patient.

Currently, stapler manufacturers don’t have to submit a premarket notification to the FDA because their products are in a low-risk category.  Other products in the Class I category include elastic bandages, latex gloves, and tongue depressors.

Should the classification be changed to Class II, however, manufacturers would have to gain an FDA review and clearance of a premarket notification submission before they could release the products on the market.

The change would also subject surgical staplers to other special controls, including mandatory performance testing, demonstration of usability and labeling comprehension, and specific labeling elements.

Types of Injuries Associated with Surgical Staplers

Surgical staplers, when they malfunction, can cause the following injuries:

• Bleeding and excessive blood loss
• Infection
• Sepsis
• Intestinal dysfunction (uncontrolled diarrhea, constipation)
• Intestinal blockage
• Organ damage
• Severe pain
• Death

What are Surgical Staplers?

Surgical staplers are medical devices used during surgical procedures to close external wounds or connect internal tissues and organs under high tension.  They can be used both externally and internally, though the FDA is reporting that increased rate of problems is linked to the surgical staplers used internally.

Much like regular paper staplers, surgical staplers bring separated tissues back together to facilitate healing, though they look more like construction staplers than office staplers, with a handle and lever the surgeon uses to apply the staple.

The staples themselves are made of a variety of materials, including titanium, plastic, and a polylactide-polyglycolide copolymer that can be reabsorbed into the body.  They can penetrate through the upper and lower layers of the skin, grasping and securing the edges to provide a secure closure.  Unlike stitches, however, most don’t dissolve (except those made of the copolymer), and they must be removed once the incision has healed—usually after a few days up to 21 days.

Surgical staplers can help close wounds that are too large or complex to close with regular stitches. They’re used as an alternative to traditional sutures in gastrointestinal, gynecologic, thoracic, and other surgeries, particularly when it’s necessary to remove part of an organ, cut through organs and tissues, and create connections between structures.

Surgical staplers are faster to apply, allowing surgeons to more quickly close a wound. They also reduce scarring, present a low risk of infection, and may be less painful than regular stitches.

Surgical Stapler Lawsuits

Plaintiffs who have been injured by malfunctioning surgical staplers have filed numerous surgical stapler lawsuits around the country.  In most of them, the defendants—the stapler manufacturers—try to shift to the blame onto the operating surgeon, claiming surgeon error and/or negligence.

Despite this tactic, many plaintiffs have received sizable awards.  Retired San Jose police officer Florence Kuhlmann, for example, was awarded nearly $80 million in damages in her surgical stapler lawsuit.  The Court later reduced the $70 million punitive damages verdict to $19.6 million and leaving the $9.8 million in compensatory damages intact.  She claimed that during a routine hemorrhoid surgery, the Ethicon surgical stapler malfunctioned, stapling her bowel shut against her rectal wall and causing an occlusion. Her bowel ruptured and she suffered from a major infection and sepsis and nearly died.

If you or a loved one underwent surgery where a surgical stapler was used and you suffered serious injuries and/or death, you may be eligible to file a surgical stapler lawsuit to recover damages. Chaffin Luhana is now investigating these cases and invites you to call today at 888-480-1123.