You may be eligible to file an Ethicon surgical staples lawsuit for the defective product. In October 2019, the U.S. Food and Drug Administration (FDA) initiated a Class 1 recall—its most serious type of recall—of Ethicon surgical staplers. According to the federal agency, the device fails to properly form staples which can increase the risk of surgical complications.
There have reportedly been several injuries caused by Ethicon surgical stapler complications and even one death. Call Timothy L. Miles, an Ethicon Recall Lawyer, and see if you meet the criteria for a Ethicon surgical stapler lawsuit.
There have been numerous recalls of surgical staplers over the years, proving just how risky they are to use. In May 2013, Ethicon, a subdivision of drug giant Johnson & Johnson, issued a Class-II recall for surgical staples sold under the name Echelon. Echelon staples were used in a number of different types of surgery, including stomach stapling surgery. The recall states that Echelon staples used in stomach stapling had been reported to misfire and break, risking serious complications.
On Oct. 30, 2019, the FDA announced the Class 1 recall of Ethicon’s Echelon Flex Endopath staplers. The FDA recall, initiated by the Johnson & Johnson subsidiary earlier in October, includes a variety of products, such as the following:
These single-user staplers were designed to be used on internal tissue during minimally invasive gynecologic, urologic, thoracic, pediatric, and general surgeries.
According to the FDA, these devices may contain a component that is out of specification—leading to malformed staples. Malformed staples could lead to serious surgical complications.Two patients were reportedly injured by the staple devices when a misfire lead to their rectums being cut. As of Oct. 3, Ethicon has reportedly received seven reports of serious injuries and one report of death.
Symptoms of Surgical Complications. In general, surgical staples can lead to surgical complications such as:
The FDA warns that the recalled Ethicon surgical staplers could be associated with more serious risks and complications.
These surgical stapler complications may be more common than reported. A 2020 review found that stapler malfunctions occur in between 0.022% and 2.3% of cases, according to observational studies. In contrast, a survey found that 86% of laparoscopic surgeons – who commonly use surgical staplers – either experienced or knew surgeons who experienced these malfunctions.
In addition to underreporting, surgical stapler manufacturers may have hidden complication reports in a hidden FDA database, according to Kaiser Health News. As a result, it may be hard for patients to know if they’re at risk for surgical stapler complications.
Despite past reporting concerns, the FDA officially reclassified surgical staplers as Class II devices in October 2021. This reclassification subjects internal surgical staplers to additional premarket reviews and more stringent approval requirements.
Patients are at risk of surgical stapler complications if they have undergone surgery that involved internal staples. Unfortunately, it may be difficult or impossible for patients to figure out which staples were used in their surgery and if they are affected by the recall.
If you had internal staples put in during surgery which later needed corrective surgery to fix, you may be affected by the recalled products and may meet the Ethicon lawsuit criteria.
An experienced medical device attorney such as Ethicon Recall Lawyer Timothy L. Miles can help you determine if or your loved one was affected by the Ethicon surgical stapler recall and determine meet the Ethicon lawsuit criteria. Fill out the form on this page to learn more about a free case evaluation by a Ethicon Recall Attorney.
Consumers who were affected by the defective staplers may be able to take legal action through an Ethicon surgical stapler lawsuit. These surgical staples lawsuits can help hold Ethicon and parent company Johnson & Johnson accountable for selling allegedly defective products. Ethicon has faced similar claims in the past due to other recalled surgery staple products. Settlements in similar lawsuits with Medtronic and other companies have resulted in deals worth between $5 million and $80 million.
If you needed corrective surgery due to complications from staples in surgery, you probably meet the Ethicon lawsuit criteria, so contact an Ethicon Recall Lawyer Timothy L. Miles today at 855/846-6529 or submitting the form below and see if you qualify for an Ethicon Surgical Staples Lawsuit.
Timothy L. Miles is a nationally recognized shareholder rights attorney raised in Nashville, Tennessee. Mr. Miles was recentely selected by Martindale-Hubbell® and ALM as a 2022 Top Ranked Lawyer, 2022 Top Rated Litigator. and a 2022 Elite Lawyer of the South. Mr. Miles also maintains the AV Preeminent Rating by Martindale-Hubbell®, their highest rating for both legal ability and ethics. Mr. Miles is a member of the prestigious Top 100 Civil Plaintiff Trial Lawyers: The National Trial Lawyers Association, a superb rated attorney by Avvo, a recipient of the Lifetime Achievement Award by Premier Lawyers of America (2019) and recognized as a Distinguished Lawyer, Recognizing Excellence in Securities Law, by Lawyers of Distinction (2019). Mr. Miles has published over sixty articles on various issues of the law, including class actions, whistleblower cases, products liability, and more.
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