Surgical Staplers and Staples Cause Triple-Digit Adverse Effects
Medical device companies are in the hot seat once again over the faulty manufacture of surgical staplers and staples. With more than 100,000 adverse events logged into FDA databases, the number of lawsuits has risen dramatically.
This has led to mass tort claims against the companies that manufactured the devices. A mass tort claim is one where injured individuals who share similar injuries with others filed a lawsuit against one or several defendants.
Although the circumstances of their claim are similar, each person maintains an individual lawsuit, and they do not join together as they would in a class action case. Those injured by surgical staplers and staples share organ damage and other problems due to the use of staples to close surgical wounds.
In this article:
- What Are Surgical Staples?
- How Are Staples Placed?
- Risks Associated With Surgical Staples
- Problems Associated With a Stapler
- Recent Recalls
- Undisclosed Reports
Surgical staplers and staples are used doing surgery to close incisions. They are commonly used instead of sutures (stitches), and many doctors prefer this method of closing. The staples differ from conventional sutures in that they are not absorbed and must be removed by a physician. They remain in the body from four days to three weeks. The length of time they are needed to remain in place is dependent on the size and location of the incision. Other factors include the sort of surgical procedure and how quickly the wound heals. The direction of the incision is also important since, generally, staples can be removed sooner in a horizontal incision than in a vertical one.How Are Staples Placed?
Surgical staples are placed with a specialized instrument called a stapler. The surgeon pushes down on a lever to insert the staples. Staplers are manufactured by several companies, most notably, Ethicon (a branch of Johnson & Johnson, 3M, Covidien (a branch of Medtronic), and Stryker, among others.Risks Associated With Surgical Staples
A few of the risks commonly seen with surgical staples include:
- Allergic reactions
- Infection leading to sepsis, which can be fatal
- Fistula formation, which is a connection between organs or tissues that should not be there
- Wound not adhering properly and reopening
- Improper placement of staple, causing poor healing
- Broken staples
- Wrongful death
Just as a desk-top stapler can malfunction, so can one used during surgery. However, in the latter case, the consequences can be life-threatening. Some of the problems associated with a malfunctioning stapler are:
- The force of discharge of the stapler may be too high or low. In turn, this can damage the tissue into which it was sent or incompletely close an incision. Additional surgery may be needed to repair the tissues.
- Sometimes, the stapler fires inadvertently. When this occurs, the staple may be lodged in the surrounding tissue or an organ. Organ damage can be an end-result of the accidental firing of the stapler.
- Staples may be placed in the wrong area. For instance, if the staple is placed in an abdominal organ or the intestine, this could lead to the contents leeching out into the abdominal cavity. Often, this leads to a serious infection, requiring long hospital stays and additional operations.
- Non-working staplers can mean that the incision is not closed for a time while the surgical team looks for another or resorts to the traditional mode of closing. This can lead to excessive blood loss and cause cardiac arrest.
The following chart shows recent surgical staplers and staples recalls:
|2013||Ethicon||ECHELON 60mm Endoscopic Linear Cutter||57,540||Problem firing a straight line of staples due to reloading issue|
|2015||Ethicon||Endopath Echelon Vascular Staplers||6,744||Full line of staples not fired|
|2019||Ethicon||Curved Intraluminal Stapler; Endoscopic Curved Intraluminal Stapler||92,496||Staplers misfired leading to rectum lacerations|
|2018||Medtronic||Endo GIA "Auto Suture" Universal Articulating Loading Unit||171,271||Staple misalignment|
|2019||Medtronic||Endo GIA Articulating Reloads with TriStaple Technology||3,113,280||Missing components leading to staple misalignment|
The FDA has had multiple reports of adverse reactions due to stapler and staple issues. They were filed in what amounted to a secret database called the Alternative Summary Reports that was never shown to the public or physicians. This program was closed in 2019 from its inception in 1997. The first inkling of adverse reactions related to the use of staplers and staples began arriving in the database in 2011, while it took until 2013 for recalls to be made. In all, there were 41,000 adverse reports found in the Manufacturer and User Facility Device Experience database from 2011 to 2018. Kaiser reported another 56,000. Data shows there were significant injuries in about 9,000 people and fatal ones in another 350.Trials
One notable trial involved a San Jose resident who underwent hemorrhoid surgery in 2011. After surgery, it was discovered that a defective stapler was used and stapled her intestine against the wall of her rectum. This blocked her intestine, causing it to rupture. The patient became septic. The jury awarded the woman $80 million in damages. Ethicon recalled the device along with similar models the same year.
Another case involved a 33-year old woman who bled to death in 2013. In this case, during elective surgery, a Covidien stapler lacerated a blood vessel without sealing it. The woman began to bleed heavily and died the day of the surgery. A jury, in this case, awarded $5 million to the family of the deceased. The verdict was against Covidien, the surgeon, and the Southern Illinois University School of Medicine.
In three cases against Medtronic, the patients were injured by defective staplers that malfunctioned in 2017. All three patients had GI surgery, and the staples needed to be placed in the organs. The staplers fired and punctured the organ. However, no staple was produced, nor did the staples close the wound. The patients suffered cardiac issues, infections, and additional surgery. The cases were filed in Texas and Minnesota in late 2019. The plaintiffs said the company knew about the defects but hid their knowledge.Sacramento Defective Medical Device Lawyer
I’m Ed Smith, a defective medical device lawyer in Sacramento. If you or a family member has been harmed by a malfunctioning stapler or staple during surgery, now is the time to reach out to an experienced attorney. Call me at (916) 921-6400 or (800) 404-5400 for free and friendly advice, You can also reach me online.
I’ve helped many Sacramentens recover damages associated with malfunctioning or defective medical devices since 1982.
I am proud to be a member of the following organizations, among many others:
Learn more about my practice by visiting the following pages:
Image by Sasin Tipchai from Pixabay
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