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Surgical Staples/Staplers

FDA REVEALS THOUSANDS OF SURGICAL STAPLE/Stapler MALFUNCTION CASES

YOU MAY BE ENTITLED TO LEGAL COMPENSATION

AVA Law Group is dedicated to supporting those suffering from  defective surgical stapler/staple injuries and complications. We will help you seek justice and compensation for your suffering.

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NEW SURGICAL STAPLES/STAPLERS WARNING REVEALS THOUSANDS OF DEFECTIVE PRODUCT CASES

Recent information released by the FDA reveals an overwhelming number of injury, malfunction, and death reports related to the use of surgical staples and implantable staples. On March 8, 2019, the FDA released a letter to Health Care Providers stating their growing concern with the two-fold medical devices and their plans to address their concerns. Surgical staple/stapler defective product lawsuits have been around for quite some time, but the FDA's recent release expresses the mounting concern of how widespread issues with these medical devices have become.

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“The U.S. Food and Drug Administration (FDA) is concerned by the increasing number of adverse events associated with surgical staples and staples for internal use and is providing additional recommendations for heatlth care providers to help protect patient safety and reduce the risk of adverse events associated with these devices,” stated William Maisel, MD MPH, Chief Medical Officer in the FDA’s Center for Devices and Radiological Health.

Additionally, the FDA disclosed their findings after examping medical device reports submitted to the FDA for both surgical staplers and implantable staples. Their results completely shocked the public. The FDA found that after combing through over 41,000 individual medical device reports recorded from January 1, 2011 to March 31, 2018, surgical staplers and staples for internal use caused the following grievous incidents:
366

DEATHS

9,000+

SERIOUS INJURIES

32,000+

MALFUNCTIONS

In response to the serious nature of their findings, the FDA plans to discuss reclassifying surgical staplers as Class II medical devices, meaning that they would require premarket submission to the FDA for approval. Surgical staples for internal use are already classified as Class II medical devices. But the FDA plans on holding a discussion about how these medical devices are marketed to the public with adequate warning and instructions.

WHAT ARE SURGICAL STAPLES/STAPLERS?

Surgical staples are common products in modern hospitals, usually used in place of manual suturing. According to the FDA, surgical staplers and staples may be applied in a wide range of surgeries to remove part of an organ, create connections between internal and external structures, and cut through organs and tissues.

Surgical staples come in several different types including titanium, plastic, and polylactide-polyglycolide copolymer. Surgical staplers are used to place external and internal staples and have advantages including quick placement, minimal tissue reaction, low risk of infection, and strong wound closure.

However, product defects or lacking informational guides for these medical devices can quickly turn them into a hazard for patients instead of a help.

COMMONLY REPORTED SURGICAL STAPLES/STAPLER PROBLEMS

Opening of the staple line
Malformation of staples
Misfiring
Difficulty in firing
Failure to fire the staple
Misapplied staples
While the FDA is trying to remedy the situation through providing detailed recommendations for health care providers using surgical staplers/staples, patients suffering from surgical stapler/staple injuries remain the victims of defective products. In 2012 a San Jose police officer was severely injured by a defective Ethicon surgical stapler that stapled her anal canal shut. After suffering with a grave infection, undergoing a colostomy and full laparotomy, and being permanently injured from the defective stapler, an Alameda County Superior Court jury awarded the now retired police officer almost $80 million in damages to her in 2015.

SURGICAL STAPLER/STAPLES COMPLICATIONS

Prolonged surgical procedures
Unplanned, additional surgical interventions
Bleeding
Sepsis
Fistula formation
Tearing of internal tissues and organs
Increased risk of cancer recurrence
Death

AVA LAW GROUP, INC. IS HERE TO SUPPORT YOU

AVA Law Group, Inc. is currently looking into surgical staple injury cases for individuals concerned their injury may have been caused by faulty products. Our lawyers possess the expertise and care to help you and loved ones through this trying time and fight for your right to legal compensation for your injuries. 

Sign up for your free case evaluation today to see if you are eligible to file a defective product lawsuit.

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ATTORNEY ADVERTISEMENT: Not available in all states, Andrew Van Arsdale, supervising attorney is licensed only in CA, but associates with attorneys throughout the country, Principal office: 3667 Voltaire Street, San Diego, CA 92106. 


No representation is made that the quality of the legal services performed is greater than the quality of the legal services performed by other lawyers. AVA Law Group, Inc. not accepting cases in states where this advertising conflicts with laws or state rules. While AVA Law Group, Inc. maintains joint responsibility, most cases are referred to other attorneys for principal responsibility. 
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