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FDA Moves to Increase Safety of Surgical Staples and Staplers

Severe Surgical Injury can be Caused by Surgical Staples and Staplers

With the advent of modern medicine, many new and exciting developments have been made when it comes to medical technology. Things such as medical imaging devices, new prescriptions, and cutting edge surgical tools have made the quality of healthcare jump leaps and bounds. Surgery has benefitted from one particular piece of technology in particular. Namely, the surgical stapler and staples it utilizes in order to suture wounds more efficiently and quickly than with surgical needle and thread. Unfortunately, there have been some issues regarding the safety of using surgical staplers and staples. According to the Federal Drug Administration (FDA), there have been several reports filed on issues arising from the use of surgical staples and staplers which has prompted the organization to take steps when it comes to approving these products for medical use. 

Product Liability Claims and Medical Devices

Medical devices much like any other product have to be designed, manufactured, and appropriately labeled for the safety of the consumer. Many agencies do their best to ensure that quality is kept to the expected safety standards but many products still slip through the cracks. This can prove to be especially dangerous in the case of medical devices that people rely on with their lives. When someone suffers an injury because of a medical device’s negligent design, manufacturing, or labeling then they might be able to file a product liability claim against those responsible for the negligence.

Product liability claims can recover you compensation for the damages that you suffered because of a medical device injury. A settlement can cover damages such as medical expenses, lost wages, disability, damaged career prospects, as well as pain and suffering. Consider Sibley Dolman Gipe Accident Injury Lawyers, PA for your legal representation when it comes to product liability claims. Our lawyers specialize in cases involving faulty medical devices and can provide you with the expertise and resources that you will need to secure the settlement that you deserve and need. To schedule a free consultation with the lawyers of Sibley Dolman Gipe Accident Injury Lawyers, PA either contact us online or call our office at 727-451-6900.

Issues With Surgical Staplers and Staples 

While surgical staplers and staples have proven to be an extremely beneficial piece of medical technology, there have been some negative impacts that have come with their use as well. Surgical staplers and staples have made the process of suturing wounds not only faster but have proven to be especially effective at keeping wounds closed when utilized correctly. They are used in a number of surgical procedures including gynecologic, gastrointestinal, and thoracic surgeries to remove part of an organ, to create connections between different organ structures, or to cut through certain tissues or parts of organs.

The FDA has received from January 1, 2011, to March 31, 2018, over 41,000 individual medical device reports on surgical staplers and staples for internal use, including 366 deaths, more than 9,000 serious injuries, and more than 32,000 malfunctions. The FDA is currently in the process of studying all of the medical device reports to better understand the situation but it is safe to assume that surgical staplers and staples are a risk for dangerous injuries and complications during or after surgery. 

Surgical Staplers and Staples Reported Problems

So far, the most commonly reported issues reported to the FDA regarding surgical staplers and staples include misfiring, difficulty in firing, an opening of the staple line or malformation of staples,  failure of the stapler to fire the staple, and misapplied staples (e.g., user applying staples to the wrong tissue or applying staples of the wrong size to the tissue)

Injuries Caused by Surgical Stapler and Staple Problems

When a surgical stapler and/or staples encounter issues during a surgical procedure either because of malfunction or misuse, then a person is at risk to have the surgical procedure prolonged, need additional surgical actions, or emergency surgical interventions. These actions could lead to additional complications. Such complications could include things such as 

  • Bleeding
  • Sepsis and other forms of infection
  • Shock
  • Tearing or puncturing of internal tissues and organs
  • Increased risk of cancer recurrence
  • Death

Medical Malpractice Lawsuits Over Surgical Stapler and Staple Misuse

Other than a product liability claim, a person may have the ability to file a medical malpractice claim if they suffer an injury because a surgeon misused a surgical stapler but not because of a stapler malfunction. A surgeon would have to breach the standard of care when they misuse the stapler or staples. This means that they would have to act negligently in a way that their peers would not have acted. For example, if a surgeon does something that no other surgeon would do such as leave stray staples in a patient or even forget the stapler itself inside of a patient then they may be found liable for medical malpractice.  Proving this requires a medical expert witness that is in the same field as the surgeon in question and could be used as a comparison to determine what the average surgeon in the situation would have done.

Contact an Experienced Florida Product Liability Attorney Today

There is nothing more discouraging than when what was meant to treat or cure a medical condition actually causes greater pain and loss. Few patients understand the weak regulations involving dangerous medical products and may make a decision regarding such without understanding the risks involved. If you have been injured by a medical product, you are entitled to the compensation you deserve to assist you in living life to its fullest. 

The attorneys at the Sibley Dolman Gipe Accident Injury Lawyers, PA have the experience you need to fight the medical corporations that are turning a fast profit at the expense of your health and well-being. Most corporations will make millions of dollars by rolling out an untested medical product before side effects and symptoms begin to develop in patients. They even anticipate this being the case. Don’t let them get away with it! Call our Clearwater office today at 727-451-6900 for a free, no-risk consultation about your rights after a failed medical implant.

Sibley Dolman Gipe Accident Injury Lawyers, PA
800 North Belcher Road
Clearwater, FL 33765
727-451-6900

Product Liability