Due to possible FDA corruption that resulted in a hidden database being used to satisfy reporting requirements, injured patients may be eligible to file a surgical staples lawsuit.

The Alternative Summary Reports (ASR) system was a secret database that held reports of device injuries and malfunctions that usually would have been included in the FDA’s Manufacturer and User Facility Device Experience (MAUDE) system, the public reporting database available to doctors.

Prior to using a new device – or after experiencing a malfunction of a device – a doctor often checks the MAUDE database to see if anyone has had issues with that particular medical product. Physicians depend upon the reports to be a comprehensive look at the issues or failures other doctors have experienced with the medical devices, and to avoid surgical staples complications and lawsuits.

FDA Corruption & Hidden Reports

Between 1997 and 2019, the FDA allowed medical device manufacturers to request the option of reporting medical device problems in its ASR database rather than the MAUDE database.

Any manufacturer allowed to use the ASR system was able to submit quarterly spreadsheets summarizing the problems experienced with FDA-approved medical devices. These spreadsheets were submitted to the FDA privately and never shared with the public or with the health care community.

By reporting to the ASR system, the manufacturer was allowed to satisfy the FDA reporting requirement without incurring the scrutiny of the public or medical community.

Any issue reported to the MAUDE database required filing an individual report on each medical device’s malfunction, which would then be available for the public and medical community to read.

What Information Was Being Hidden?

Any medical device malfunction that resulted in the death of a patient was not allowed to go into the secret ASR database, according to the FDA.

Many patients suffered serious injuries, some nearly dying.

Some doctors allege FDA corruption due to the fact that more than 56,000 reports of surgical stapler problems were kept secret between 2011 and 2018 because the malfunctions were submitted to the hidden ASR database instead of the public MAUDE system. The FDA’s executive summary showed the total reports of surgical stapler malfunctions was truly more than twice the amount publicly known through MAUDE. A total of almost 110,000 injuries or malfunctions were reported in the combined secret ASR and public MAUDE reporting systems.

For years, the FDA considered surgical staplers to be a low-risk item, a category that includes tongue depressors, according to a report by Kaiser Health News. Surgical staplers are used on patients who need minimally invasive surgeries. The devices are designed to cut tissue and blood vessels and to immediately seal them.

However, surgical staplers can have devastating effects on patient outcomes if they are used improperly.

Often, stapler malfunctions occur when doctors choose the wrong size of stapler to use on the patient, or do not have clear visibility of the area they are stapling. In these cases, patients have experienced serious complications including organ failure and death after being injured by a misused surgical stapler. Even in cases where surgical stapler misuse does not result in catastrophic damage, patients may still experience complications with the healing process.

Due to potential FDA corruption, many patients may not even have known they were at risk of experiencing a stapler malfunction.

In December 2019, surgical stapler misuse was named the top health technology hazard for 2020 by ECRI. ECRI is a non-profit company that compiles an annual list of technology hazards in the field of medicine.

Among the top ten hazards named in the 2020 report are cybersecurity risks and healthcare data breaches, patient charts missing data regarding metal implants that could make tests such as MRIs dangerous, unproven surgical robotic procedures, infections caused by sterilization errors, medication dosage errors, and loose nuts or bolts in surgical devices and implants.

Surgical stapler misuse was deemed more hazardous than any of these other potential issues.

ECRI Institute CEO Dr. Marcus Schabacker made a statement about the list, saying, “Injuries and deaths from the misuse of surgical staplers are substantial and preventable. We want hospitals and other medical institutions to be in a better position to take necessary actions to protect patients from harm.”

In addition to the surgical stapler reports going to the secret ASR database, the FDA allegedly allowed Allergan to hide breast implant ruptures and injuries by reporting those through the ASR database as well. When the FDA reporting administrators changed the breast implant injury reports to the MAUDE database, the number rose from 200 annual incidents to 4,567 in 2017 and 8,242 in the first six months of 2018, according to a recent lawsuit filed by a woman who received Allergan breast implants.

FDA Alternative Database

The FDA ended the ASR program in June 2019. At that time, the agency issued a statement that said the program was created to allow “the FDA to more efficiently review reports of well-known, well-understood adverse events, so we could focus on identifying and taking action on new safety signals and less understood risks.”

Doctors such as Dr. Douglas Kwazneski don’t buy the FDA’s reasoning on the creation or secrecy of the ASR report. Dr. Kwazneski told Kaiser Health News that he ran into an issue with a surgical stapler locking up when he was operating on a patient’s abdomen.

Wondering if the malfunction was a fluke or if others had experienced such an issue, Dr. Kwazneski looked at the FDA’s MAUDE database and said he didn’t find anything there.

Still not really convinced he could have been the only surgeon to encounter an issue with the surgical stapler, Dr. Kwazneski conducted his own survey and found that two-thirds of leading surgeons surveyed had wrestled with a similar stapler problem or knew a surgeon who had.

When Dr. Kwazneski learned the surgical stapler companies had been given the choice to send reports of malfunctions to the secret ASR database instead of MAUDE, he was stunned. “I don’t want to sound overdramatic here, but it seemed like a cover-up,” Dr. Kwazneski told Kaiser.

The Surgical Stapler Problem

Upon the unveiling of the secret ASR database, the FDA admitted there were reports of 366 deaths, 9,000-plus serious injuries and upwards of 32,000 malfunctions, all associated with surgical staplers since 2011.

Most of the malfunctions mentioned the staplers misfired or emitted malformed staples. However, some of the incidents included mentions that the medical provider stapled the wrong tissue or stapled the wrong side to the tissue, according to MedPage Today.

Doctors Kept In The Dark

Madris Tomes formerly worked at the FDA as a device-report viewer, but started her own business, Device Events, to help procure a more comprehensive, current and transparent database than that run by the FDA.

“Providing these registry exemptions makes it so that deaths can be summarized and very difficult to quantify even to the manufacturers,” Tomes said in an email to the Minneapolis Star Tribune. “When a summary report is submitted to the FDA there is no narrative, which is the section that explains the patient outcome. To make matters worse, the patient problem codes (outcomes) are redacted by the FDA.  This renders the summary reports almost useless.”

Patients Affected by Defective Surgical Staplers

After the FDA corruption was uncovered, countless patients have detailed the horrors of experiencing defective surgical staples.

According to one woman who had surgery in 2017, problems related to surgical staples resulted in her development of an infection. Following her November 2017 colon surgery, she claimed that she felt constantly nauseated and could barely keep down water. After she went back to the hospital for a second surgery in December, she says that her doctors found her abdomen to be infected and full of pus. She claims that the infection was caused by a malfunctioning surgical stapler that caused a bowel leak. In order to fix the issue, she had to undergo several additional surgeries to repair her colon, as well as to fix hernias that occurred due to these procedures. Her recovery process took approximately one year.

Another patient who received surgical staples during bariatric surgery in 2014 claims that a defectively designed stapler resulted in a break in her gastrointestinal system. She claims that this injury resulted in her development of gangrene, which caused her legs to be amputated.

At least one surgical stapler lawsuit has resulted in a multi-million dollar settlement for the victim. A woman who underwent surgery in 2012 claimed in her lawsuit that her doctors stapled her bowel to her rectal wall. This error resulted in a bowel rupture and the development of sepsis, a potentially deadly condition. She was awarded almost $80 million, although this amount was eventually reduced to around $20 million.

What Surgical Staplers Are Affected?

Surgical staplers made by Medtronic and others made by Johnson & Johnson’s Ethicon subsidiary are among the allegedly defective devices.

The FDA announced that both Medtronic’s Covidien Endo GIA surgical stapler and Ethicon’s Endo-Surgery Intraluminal Staplers were under recall.

The Endo GIA surgical stapler was subject to a Class II device recall in January after the FDA determined there was potential for the sterile barrier to be breached. A compromise in the sterile barrier could potentially increase the risk of infection for the patient. Medtronic notified health providers on Jan. 17 that they should immediately discontinue using the Covidien Endo GIA surgical stapler, quarantine the item, and return the staplers to Medtronic.

Ethicon’s Endo-Surgery Curved Intraluminal Stapler and Endo-Surgery Endoscopic Curved Intraluminal Stapler were both recalled under the FDA’s most serious type of recall, the Class I recall, which means the use of the devices could lead to serious injuries or death. These staplers may have been used in patients who received gastrointestinal surgery, such as colorectal cancer and bariatric surgeries.

Ethicon notified health care facilities and distributors in April 2019 to remove the staplers by placing them in quarantine and return them to Ethicon.

Unfortunately, these defective surgical staplers were widely distributed and used by surgeons across the U.S. before anyone knew of the problems with them. The FDA has assured the health care community and the public that a secret reporting database will not be maintained again and that it is committed to full transparency.

Even so, patients who were injured due to medical device malfunctions that the FDA hid from doctors may qualify to participate in a class action lawsuit investigation or an individual lawsuit.

Join a Free Ethicon Surgical Stapler Lawsuit Investigation

If you or a loved one suffered from surgery complications caused by internal staples, you may qualify to joing in a Ethicon surgical stapler lawsuit investigation.

See if you qualify by filling out the free form on this page. 

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