In March this year, Kaiser Health News conducted an investigation that found that the FDA gave manufacturers of surgical staplers an “exemption” to file malfunctioning device reports in a database that the public did not have access to. After these findings, the FDA has sent letters to health care providers to inform them about a committee being set up to update safety recommendations for defective staplers and to reduce the number of patients being injured. The FDA says the agency will review hidden adverse event reports submitted between 2011 and 2018.
Thousands of Malfunctioning Surgical Staplers Reports Were Hidden By FDA
Recently, news emerged of a “secret” system that the FDA maintained for reports of defective medical devices and other medications. The ensuing controversy not only resulted in the end of this system, but also promises to release to the public the adverse event reports that were previously hidden. The FDA is now addressing safety issues that have only recently come to light for some of the products whose reports were previously undisclosed. One of the emerging issues is surgical staplers who are alleged to be responsible for hundreds of deaths and countless additional injuries.
There have been over 41,000 adverse event reports filed with the FDA. These reports are filed when a patient believes that they have suffered some sort of harm from the medical device. In most cases, these reports are made public so people can get a sense of whether a device is dangerous and healthcare providers can act accordingly. Here, there was an exemption that allowed these particular reports to be hidden from the general public. Only a small fraction of these reports were available in widespread fashion. In 2016 alone, there were over 10,000 reports of harm from this device, but only 100 were visible to the public. As a result, there was a perception that surgical staplers are a safe product, and it appeared that there were very few issues. Given the true number of reports, that was not the case.
Reclassify Medical Device
Since these issues have just begun to emerge, there has been growing pressure on the FDA to reassess its stance on surgical staplers. The FDA has the ability to change how it rates medical devices and products based on the risk. Each device is assigned a class rating based on the risks attendant to that product.
In March 2019, the FDA alerted healthcare professionals that it was concerned about the increasing number of adverse event reports associated with surgical staplers. The agency gave further recommendations to healthcare providers as to how to safely use the product. These were primarily instructions on how to properly use surgical staplers in a manner that would avert possible harm to the patient.
More importantly, the FDA also announced and convened a meeting to discuss whether or not to reclassify surgical staplers in a higher risk category. The FDA has indicated that it may be necessary to change the classification from Class I to Class II. Currently, surgical staplers are considered to be a Class I, which is the lowest risk medical device. One thing that would happen if staplers were reclassified is that the FDA could institute mandatory special controls that would have to be followed. This would mitigate some of the known risks of surgical staplers.
In addition to circulating draft guidance to reclassify the staplers, the FDA also ordered a Class I recall of Ethicon surgical staplers. Ethicon is a subsidiary of Johnson & Johnson and is one of the market leaders in the industry. These staplers did not properly fire the staples and also did not fully form them. This compromised the integrity of the staple line and resulted in injuries to two patients. The FDA noted that there was a shift in the manufacturing process around the time that the defect was noted.
What Are Surgical Staplers?
Surgical staplers are used during medical procedures to both close external and external wounds. They are intended to provide a straight line of suturing that allows for easier healing. The stapler forms and pushes out the staples into the affected area. Then, the staples are easily removed in a doctor’s office once the patient is healed.
What Complications Do Defective Surgical Staplers Cause?
There have been several complications that have resulted from the use of surgical staplers. These include:
- Bleeding, both internal and external
- Risk of severe infection that can lead to sepsis
- Recurrence of cancer during surgery is intended to remove a tumor
- Tearing of internal organs and tissues
Surgical Stapler Lawsuits Are Now Being Filed
There have already been several lawsuits filed regarding potential product defects in surgical staplers. It is likely, given the spotlight that has been focused on this product recently, that many more lawsuits will soon be filed. Since an overwhelming majority of the adverse events were hidden from the general public, the scope of the problem is just now becoming known. The plaintiffs’ attorneys are aggressively investigating potential defects in surgical staplers and readying thousands of claims to be filed depending on the results of the investigations.
Have You Been Injured By Malfunctioning Surgical Staplers?
The lawyers at KBA Attorneys have many years of experience in pursuing manufacturers of defective medical devices in court. They fight hard to hold these device makers accountable for the damage that their products have caused.
Due to the sheer number of possible claims based on adverse event reports, it is likely that these manufacturers will vigorously defend themselves in court. Absent that defense, the amount of potential liability will be high. That is why plaintiffs need an experienced and aggressive defective surgical stapler lawyer to fight for them so that they can receive financial compensation for the harm that they have suffered.
Mary Kekatos. “FDA is planning to review the safety of surgical staplers after thousands of malfunction reports were ‘hidden’”, Daily Mail, https://www.dailymail.co.uk/health/article-6823759/FDA-planning-review-safety-surgical-staplers-thousands-malfunction-reports-hidden.html. Accessed June 11, 2019.