The FDA has recently announced a safety review of surgical staplers. On March 8, 2019, the FDA sent medical providers a letter alerting them of the risks of the devices as well as safety recommendations for using the staplers. Surgical staplers are used during surgeries internally for tissue closure or externally for skin closure. Surgical staplers are an alternative to nylon sutures and are generally preferred because they tend to cause less inflammation and shorter surgical procedure time. The two main manufacturers of surgical staplers are Medtronic/Covidien and Johnson & Johnson/Ethicon.
FDA Issues Safety Letter to Medical Providers
The FDA’s letter to health care providers warned that they had received over 41,000 reports of death, injury, or malfunction for internal use from surgical staplers and staples. The FDA also outlined a plan to recommend that manufacturers change their product labeling to reflect the risks of the staplers and surgical staples. Finally, the FDA is considering a reclassification of surgical staplers/staples that will give the FDA more control over testing, utilization and labeling of the devices.
Injuries Associated with Faulty Surgical Stapler/Staples
The injuries were largely caused by surgical staplers misfiring or failing to fire the staples.
When a malfunction happens, the FDA warns that patients can suffer from:
- Bleeding
- Infection
- Sepsis
- Tissue or organ tears
- Formation of fistulas
- Death
FDA Secret Database for Adverse Events Associated with Medical Devices
Interestingly, many of the injuries cited in the FDA’s letter were not previously disclosed or made available to the public, or even medical professionals. The FDA established an internal, secret database that many medical device manufacturers used to report adverse events associated with their devices. There is a public database called MAUDE (the Manufacturer and User Facility Device Experience) which tracks any serious injuries or deaths that may have been caused by medical devices. This database is used by doctors and the general public to understand the risks of using certain devices. However, some manufacturers can ask the FDA for an exemption from reporting to MAUDE and instead report any adverse events to a private FDA database. The FDA says that this database, called the Alternative Summary Reporting (ASR) program, began as a way to reduce redundant paperwork associated with reports of injury and malfunction of medical devices. Some device manufacturers who were granted an exemption could instead send the FDA quarterly, semiannual, or annual spreadsheets showing these injuries or malfunctions. Death reports were required to go to MAUDE.
Recently a Kaiser Health News (KHN) investigation revealed the existence of the alternative summary reporting program. Their research exposed at least 1.1 million adverse events that were reported to this secret database (as opposed to the MAUDE system) since 2016.
Medtronic is one of the manufacturers who were granted the exemption, so the reports of adverse events associated with their surgical staplers were largely unavailable to the medical community and to the public. The KHN investigation revealed that in 2016 10,000 surgical stapler/staple adverse events were reported through the secret database, while only 84 events showed up in MAUDE.
Contact Brett Oppenheimer, Attorney with your Potential Surgical Stapler Injury Claim
Surgical staplers and surgical staples are commonly used in a variety of medical procedures. Many victims of faulty staplers have already filed lawsuits against the manufacturers, and a number of them have gone to trial and received jury verdicts in their favor, or reached a settlement with the manufacturers.
Contact our attorney if you feel you were injured as the result of a faulty surgical stapler or faulty staples. Brett H. Oppenheimer, PLLC has taken on large medical device and pharmaceutical companies to make sure that they were held accountable for their faulty medical devices.
Make an appointment with Brett today by calling (502) 242-8877 or by filling out the contact form on this page.