If you underwent surgery in which an Ethicon stapler was used, you may be at risk for complications such as internal bleeding and even death.

In 2019, Ethicon recalled several surgical staplers due to concerns that the devices could malfunction. Defects with the staplers may lead to serious issues such as bleeding, sepsis, and more.

If you’ve suffered from complications due to surgical staplers, you may want to check if the recalled Ethicon stapler products were used during a past surgery. Most patients won’t know which surgical stapler was used in their surgery without asking their surgeon or doctor. If you’re uncertain how to find this information, speak to your surgeon or doctor for help. If you no longer have contact with your doctor, you may be able to contact the hospital where your surgery occurred to retrieve your records.

Surgical Staplers: Overview

Surgical staples are used both internally and externally to close wounds, resect tissue, and more. Unlike other types of closures, surgical staplers are quick and strong while posing a low risk for infection or tissue reactions.

Unfortunately, there have been repeated safety concerns associated with these devices in recent years. To increase regulatory control over surgical staplers, it has been proposed to reclassify the devices from Class I to Class II. Under this classification, devices would have mandatory special controls and require pre-market submission to the FDA for approval.

Although this proposed change is still under discussion, the FDA aims to keep patients safe from dangerous products.

Ethicon Surgical Stapler Recall

In 2019, Ethicon announced the recall of two staplers — their Endo-Surgery Endoscopic and Curved surgical stapler products — due to concerns that the devices fail to work as intended. According to the FDA recall announcement, uncut washers within the stapler can lead to firing problems and malformed staples.

Unfortunately, this can have deadly consequences for patients. Even if staplers are fired as intended, the integrity of the resulting closure may be too weak — meaning that a patient’s wounds aren’t correctly closed. If a staple misfires, patients can suffer from internal injuries which may lead to additional surgery, bleeding, sepsis, and even death.

The FDA recall notice reveals that two patients sustained “serious injuries” as a result of the recalled Ethicon staplers. In both patients, misfiring caused additional tissue removal during gastrointestinal surgery.

Take Action For Injuries From Ethicon Surgical Staplers

A growing number of patients have already been successful in bringing lawsuits against Ethicon and parent company Johnson & Johnson. Should you discover that your surgical complications are linked to an Ethicon surgical stapler product, you may be able to take legal action.

Filing a lawsuit can be a daunting prospect, so Top Class Actions has laid the groundwork for you by connecting you with an experienced attorney. An experienced attorney can help evaluate your situation and, if possible, take action to recover medical expenses and other damages.