Surgical disposable staplers and staples are medical devices that can be used in place of sutures. They allow faster closure of large wounds or incisions and are less painful for the patient than sutures. They can also be used to close wounds in areas where the skin is close to the bone and for procedures that remove organs or reattach parts of internal organs.
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They are useful in minimally invasive surgery because they require only a narrow opening to quickly cut and seal tissue and blood vessels. Skin sutures are used externally to close the skin under high tension, for example on the skull or body trunk.
What are surgical staples made of
Common materials used for staples in surgery include stainless steel and titanium. These are strong metals and tend to cause little or no problems for patients during surgical procedures.
However, plastic staples are often used for people who are allergic to metals or to reduce scar tissue. Staples made of plastic or metal do not dissolve like many sutures, so extra care must be taken to prevent infection.
Staples made from polypropylene and polyethyleneglycol are intended to be reabsorbed by the body. They are often used in cosmetic surgery because, like plastic staples, they reduce scarring.
How do surgical staples work
Surgical staplers work by compressing tissue, joining two pieces of tissue with interlocking B-shaped surgical staples, and, in some models, cutting away excess tissue to create a clean closure of the surgical wound.
There are several designs for different types of surgery, most of which are classified as linear or circular. Linear staplers are used to attach tissue or remove organs during minimally invasive surgery. Disposable circular staplers are commonly used for procedures involving the digestive tract from the throat to the colon.
When using a disposable linear stapler, the surgeon uses a handle on one end to close the "jaws" of the other end of the suture on the tissue.
The circular stapler fires two interlocking rows of staples from a circular cassette. This circular layout allows the anastomosis to connect two sections or another tubular structure after a portion of the intestine has been removed. The staples allow the tissue to be sandwiched between the staples to form a ring or doughnut. The built-in blade then cuts away the overlying tissue and seals the new connection.
The surgeon observes the closed wound for approximately 30 seconds to ensure that the tissue has been properly squeezed together and to confirm that there is no bleeding.
Surgical staplers are used in gastrointestinal surgeries across the country. In fact, they have been in use for over half a century. However, over 92,000 of them have been recalled recently due to documented evidence of their causing significant injuries and death.
Injuries linked to surgical staplers include internal organ damage, uncontrolled internal bleeding, and infection, all potentially life-threatening.
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Dangers of Surgical Staples
It’s clear that the use of surgical staples can present dangers to patients. The U.S. Food and Drug Administration (FDA)’s Manufacturer and User Facility Device Experience (MAUDE) data indicates that over 41,000 adverse event (AE) reports were received between and the end of March . In it, there are 32,000 reports of surgical staplers malfunctioning, and 9,000 serious injuries to patients caused by surgical staplers. Over 350 fatalities have been reported.
Even more disturbingly, those reports don’t include more than 56,000 reports submitted to the FDA in the same time frame. These reports only became public knowledge when Kaiser Health News reported on their existence.
As a result of the Kaiser Health News report, the FDA announced that it will be reviewing surgical stapler safety.
What Types of Injuries Occur With Surgical Staplers?
Surgical staplers are used to close incisions and wounds, rather than sutures.
However, malfunctions, improper use, and defects in the design have apparently caused numerous patients to suffer injuries and complications after surgery. These can be long-term, permanent, or even require additional surgery and ongoing treatment to rectify.
Injuries associated with surgical staples include:
- Organ damage
- Internal bleeding
- Infections
- Fistula (abnormal connection between organs and blood vessels)
- Death
The AEs indicate that the most frequent malfunctions are:
- Misfiring or difficulty in firing
- Failure to fire staples
- Using the incorrect staple for a given surgery
- Leaks in the staple line (the wound or incision closure)
- Staple malformation
What Can Affected Patients Do?
Affected patients and their loved ones (if a patient has died) do have recourse. If you suffered an injury or complication due to issues with surgical staples, you can seek compensation for damages from the manufacturers via a legal claim.
Surgical staplers are manufactured by Ethicon (a division of Johnson & Johnson), 3M Corporation, Covidien, Stryker Medical, Tyco Medical Group, and U.S. Surgical.
Possible compensation for damages include:
- Medical treatment costs, both past and prospective
- Loss of wages from work caused by the injury/complication, both past and prospective
- Loss of earning capacity, if the person’s ability to work is affected, both past and prospective
- Pain and suffering, both physical and mental
- Funeral expenses if the patient died
- Punitive damages, if appropriate.
If You Need an Experienced Law Firm
Questions about whether you are eligible to file a surgical stapler lawsuit? If you or a loved one has been injured or suffered complications from the use of surgical staples, by any manufacturer, call Chaffin Luhana today. We are experienced in product liability law as it applies to surgical staples, and are dedicated to fighting for the rights of patients who have been victimized by defective medical products.
For more information, please visit endo stapler.
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