Surgical staplers are generally made of plastic and loaded with a disposable cartridge of surgical staples. The staplers come in both reusable and disposable models. They resemble construction or industrial staplers and are designed to insert and close several staples at once.
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The devices may be used internally to seal tissue during surgery. They are useful in minimally invasive surgery because they require only a narrow opening and can quickly cut and seal tissue and blood vessels. Skin staplers are used externally to close skin under high tension, such as on the skull or the trunk of the body.
Surgical staples offer several advantages over sutures.
Surgical staplers are frequently used to close incisions in the abdomen and uterus during Cesarean deliveries, or C-sections, since the staples allow women to heal faster and reduce scar tissue. Surgeons may also rely on surgical staplers when removing part of an organ or cutting through organs and tissue inside the body.
They are also used to connect or reconnect internal organs within an organ system. The devices are frequently used for surgeries involving the digestive tract, including the esophagus, stomach and intestines, in which a portion of these tube-like structures have been removed and the remaining portions must be reconnected.
Patients must pay special attention to medical staples in the skin to avoid infection. A study reviewed the surgical site infection rate of wound closure using staples versus sutures in elective knee and hip arthroplasties. The researchers found a significantly higher risk of surgical site infection in patients with staples compared to sutures.
Always follow your doctor’s instructions and do not remove any dressings until it’s safe to do so. Rinse the site twice daily to keep it clean. Your doctor will tell you how and when to dress the wound to prevent infection.
When to Call Your Doctor About Surgical Staple Complications
Surgical staples usually remain in place for one to two weeks, depending on the type of surgery and the placement of the staples. In some cases, internal staples may not be removed. They are either absorbed or become permanent additions to hold internal tissue together.
Removing surgical staples from the skin is generally not painful. But they should be removed only by a doctor. Never attempt to remove surgical staples on your own.
Removal requires a sterile setting and a specialized surgical staple remover or extractor. The device spreads one staple at a time, allowing the doctor to gently work it out of the skin.
Usually, a doctor will remove every other staple, and a second appointment is scheduled to remove the rest if the wound has not completely healed.
Surgical staplers work by compressing tissue, connecting two pieces of tissue with staggered rows of B- shaped surgical staples and, in some models, cutting away excess tissue to create a clean closure of the surgical wound.
There are various designs for different types of surgeries, with most categorized as either linear or circular.
When using linear staplers, the surgeon uses the handles at one end to close the “jaws” of the stapler at the other end over the tissue. When the surgeon fires the stapler, a row of staples binds the tissue together and a blade cuts the tissue between the staples. The process seals the open wound to prevent bleeding.
Linear staplers are used to connect tissue during minimally invasive surgeries or to remove an organ. Circular staplers are often used for surgeries involving the digestive tract from the throat to the colon.
Circular staplers fire two staggered rows of staples from a circular cartridge. This circular layout allows the stapler to connect two sections of the intestine, or another tube-like structure, after a portion has been removed. The staples cause tissue to pinch up as rings or donuts between the staples. A built-in blade then slices off the overlaying tissue, sealing the new connection.
Surgeons watch the closed wound for about 30 seconds to make sure the tissue has been squeezed together properly and confirm that there is no bleeding.
Common materials for surgical staples include stainless steel and titanium. These are both strong metals that tend to cause few problems for patients in surgical procedures.
But plastic staples are frequently used for people with metal allergies or to reduce scar tissue.
Staples made from plastic or metals don’t dissolve like many sutures, so extra attention must be paid to prevent infection.
Staples made from polylactide-polyglycolide copolymer are designed to be reabsorbed into the body. They are often used in cosmetic surgery because, like plastic staples, they result in less scaring.
Johnson and Johnson’s Ethicon division and Medtronic are the two largest surgical stapler manufacturers. Together, they produced about 80 percent of the stapler market in , according to an analysis by Future Market Insights. 3M also manufacturers skin staplers sold in the United States.
The devices accounted for close to $2 billion in revenue for manufacturers in , with most sold in North America.
Surgical Stapler Manufacturers and Select BrandsJohnson & Johnson subsidiary Ethicon recalled 92,496 surgical staplers in April over concerns that they might not fire with enough force to completely form staples.
The U.S. Food and Drug Administration branded the recall as a Class I recall, the FDA’s most serious type. The agency warned in a statement that the devices could cause serious injuries or death. Some people who have been injured by malfunctioning devices have suffered serious injuries and filed surgical stapler lawsuits.
The recall affected two models of the company’s Endo-Surgery Intraluminal Staplers used in gastrointestinal tract surgeries.
Ethicon reported that two patients had been injured by the devices, according to the FDA. In both cases, the devices misfired, cutting portions of the rectum. Misfires or other malfunctions can prolong operations or require doctors to perform unplanned surgery to correct the damage.
The FDA warned that the misfires could increase complications from surgical staplers, including the risk for bleeding, infection, permanent damage to organs.
In , Ethicon recalled 6,744 Endopath Echelon Flex Powered Vascular Staplers with Advanced Placement Tip and White Reloads. The devices were used in gynecologic, urologic, thoracic, pediatric and general minimally invasive surgeries.
The company reported that an inspection had found the surgical staplers’ cartridges may not insert a complete line of staples when fired.
Medtronic issued two recalls of its Endo GIA staplers and staple cartridges from select production lots, or batches, in and . Both recalls involved possible missing components. The company said the defects could affect staple alignment and lead to serious complications.
At least five people were injured by staplers included in the recall, according to the company. The recall involved defects in staple cartridges that were spotted during the manufacturing process. The company reported “no confirmed complaints” about the devices from doctors or patients.
The U.S. Food and Drug Administration began tightening restrictions and reporting safety concerns over surgical staplers in . It issued new guidance for using the devices to doctors and hospitals, took steps to reclassify certain surgical staplers from low- to moderate-risk devices and reported tens of thousands of previously unknown cases of stapler malfunctions and injuries.
The new classification would require premarket review and clearance of the devices from the FDA before manufacturers could sell them.
The FDA actions followed a series of surgical stapler problems coming to light earlier in . Kaiser Health News reported that more than half of all surgical stapler malfunctions from through , 56,000 of them, had been reported to a hidden FDA database instead of a database accessible by the public.
The FDA consolidated the two databases so all the reports could be viewed by the public. The total number of reported surgical stapler malfunctions over the eight-year period rose from 41,000 to nearly 110,000.
From the desk of:
Andy Bederman, Managing Attorney
To Surgery Patients:
If you (or a loved one) received surgical staples during a surgery that occurred between March 15, and November 1, , this may be the most important message you will ever read...
Here is why...
In May, the FDA issued a Class 1 Recall (the most serious) for the Ethicon® Endo-Surgery Curved Intraluminal Staplers -- due to alarmingly high-rates of reported failures and complications during surgery.
And again in October, the FDA issued another Class 1 Recall for the Ethicon® Echelon Flex™ Endopath® Staplers.
Please continue reading as these new developments may have a significant impact on you...
Contact us to discuss your requirements of endoscopic stapler. Our experienced sales team can help you identify the options that best suit your needs.
The Ethicon® Endo-Surgery Curved Intraluminal Stapler (and its endoscopic variation) and Echelon Flex™ Endopath® Stapler are surgical staplers that are commonly used in the following types of surgery...
These defective staplers were widely used by surgeons between the dates of March 15, to November 1, before the FDA recall was issued.
A total of 100,725 affected staplers are part of the recalls – and already there are mounting reports of serious injuries in patients who received staples from these devices.
The recalled staplers received increasing reports for "misfiring staples" – which cause serious damage instead of having the intended effect of repairing the gastrointestinal tract, stomach, colon or intestines (to name a few).
This serious defect in the staplers also produces "malformed" staples. It is these malformed staples that have caused serious injuries in patients.
The injuries from the malformed staples can include the following...
Not necessarily.
It is possible that your surgeon didn’t realize the staples became malformed.
Many surgeons reported immediate feedback upon staple insertion of the stapler malfunctioning and "misfiring". There are reports from surgeons of strange, crunching noises that occur during device malfunction.
Oftentimes the surgeons can clearly see that the staple procedure "went wrong". Noticeable signs of serious injuries, such as tears and perforations, are often immediately apparent.
But, not for every patient.
Some patients may be told the surgery "went well" – and the doctor may not be aware that the staples were malformed and did serious damage on entry.
Only after the patient suffers health complications post-surgery and visits their surgeon for a follow-up, do they determine that the staples may be to blame.
And because the recalls are so recent (May and October ), many doctors in the period before the recalls were announced may not have suspected the staples could be the cause of complications.
During this period before the recall, many surgeons were still "in the dark" and unaware that the Ethicon® Surgical Staplers were defective – which may have lead to exploratory surgery to discover the culprit.
If you are still reading this, it means you likely fall into this scenario...
Our law firm is helping patients find out if they received surgical staples from the recalled Ethicon® Staplers. With your authorization, we are able to obtain your surgical records and confirm whether the affected staplers were used in your surgery.
If you believe you have been affected by the surgical stapler recall, you likely have experienced one or more of the following complications that required medical attention:
So please continue reading because it is critically important for you to understand not only the medical aspects of all this, but also the LEGAL aspects behind your safety and well-being.
Medical device manufacturers are subject to STRICT guidelines and rules by the FDA.
The FDA puts rules in place that require medical device manufacturers to conduct extensive testing, research and clinical trials before their device can be used in operations.
...this is done so doctors and patients like YOURSELF can weigh the benefits of using a particular medical device against the possible dangers and consequences it may pose.
And it gives doctors the ability to make an informed decision about which brand surgical stapler to use, based on available safety data gathered in pre-market testing and trials.
As a result of Ethicon®, Inc (a subsidiary of Johnson & Johnson®) failing to design a sufficiently safe and effective surgical stapler, you or a loved one may have suffered negative health consequences, needed additional surgeries, experienced emotional pain, incurred lost wages due to time off work, and other significant related expenses.
Because of this... you may be entitled to what are called "damages", which is just a legal term for money awarded in individual lawsuits, settlements and class action lawsuits.
Because the Ethicon® Surgical Staplers had such a high-rate of failure, complications and need for additional surgeries, patients often find themselves burdened with substantial medical expenses.
Why should you have to bear the financial and emotion burden due to a defective surgical stapler?
Our legal team has reviewed the available evidence and research, and our experience in medical device liability cases tell us, that we are in prime position to effectively help patients who are victims of the Ethicon® Surgical Stapler Recall and any subsequent injuries suffered.
We are offering a free legal consultation and case evaluation to patients who believe they may be affected.
If you'd like to learn more and speak with a surgical stapler recall lawyer free of charge, this is your opportunity to discover the help that is available to you.
Getting started is simple and easy...
Fill out the contact form below or call us at 855-201- for a free case evaluation and legal consultation. We will personally speak with you about your case.
Speaking to an attorney, you will get answers to the following...
This consultation with an attorney does not cost you anything and is 100% free and confidential. That means you have nothing to lose and everything to gain.
You will speak to our attorneys -- lawyers with years of experience getting successful legal outcomes for victims like yourself.
We are currently accepting cases from all 50 states in the United States, so you are eligible to speak to us for free -- no matter what state you live in.
You should contact our firm if:
And know this...
If at any point you do not believe we are the most qualified to help you get the compensation you rightfully deserve, you are not obligated in any way, shape or form to pay us or work with us. This is a NO-PRESSURE consultation.
We are confident you will see the extraordinary value we can offer you. Our law firm works strictly on a contingency basis -- meaning patients we represent only pay out of their recovery if they win their case.
You must act quickly because there is only a small window of time that patients can file a surgical stapler lawsuit or seek an Ethicon® settlement. This is called the "statute of limitations" -- and it is different for every state.
So act now and fill out the contact form at the bottom of the page. Or simply pick up the and call us right now at 855-201-.
We stand ready to help you win your case.
Sincerely,
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