Fatal Risks Associated with Ethicon Surgical Staples and Staple Guns

Doctors often use surgical staples instead of sutures (stitches) to close incisions during surgery.

Surgical staples are made of either metal (usually titanium or stainless steel) or nylon, and they are used in gastrointestinal, gynecologic, thoracic (neck), and bariatric (weight loss) operations, among other types of surgery.

Staples have become standard in hospital settings because they take less time to insert and are more consistent in size than sutures.

Yet, such convenience can be costly. Studies show that staples may significantly increase the risk of infection and other serious complications. The risks are especially high after cesarean delivery, for instance. And after orthopedic procedures in general, the risks are three times higher. Specifically, wounds closed with staples during hip surgery are particularly prone to infection. The risk is up to four times greater with staples than with sutures, and if a hip surgery incision becomes infected, it can spread through the skin and tissue to the implant, the British Medical Journal reports.

If you or a loved one have been injured as a result of surgical staples

You need to consult us as soon as possible if you have sustained an injury as a result of surgical staples. An attorney can gain access to medical records and corporate document that doctors and medical device manufacturers may try to keep you from seeing. An attorney can also prepare your case before the statute of limitations to make a claim expires.

Serious complications

Ethicon markets its staples and staple guns as being more efficient and exact than hand-stitching sutures in operations that require removing, cutting, and sealing connections between organs and tissue.

However, there are lethal risks associated with using surgical staples for such procedures, including:

  • Inadequate staple size

Staples come in various sizes. If a doctor uses a staple that is too small relative to tissue thickness, staples can break or loosen.

  • Staple guns used to insert the staples can malfunction

Staplers that fail to fire or misfire, or that fail to correctly form staples cause 90% of injuries associated with surgical staples. 

Ethicon monopolizes defective surgical staple manufacturing

While surgical staples and staplers are widely used in hospitals throughout the country and around the world, only one company controls the majority of their design, manufacture, and marketing.

Ethicon Endo-Surgical, Inc., a division of Johnson & Johnson, controls two thirds of the surgical staple industry─even though the U.S. Food and Drug Administration (FDA) has found certain of its products defective.

FDA recall

In 2012, the U.S. Food and Drug Administration (FDA) issued a Class I recall, the most serious type of recall, of Ethicon’s Endo-Surgery circular stapler. The recall was based on reports from physicians who were forced to abandon use of the stapler during surgery, because it was too difficult to fire.

Also in 2012, Ethicon voluntarily globally recalled more than 157,000 surgical staplers when it discovered that the staplers were not firing correctly and were causing staple formation failure.

Risks of severe injury or death

When surgical staples break or loosen, or when staplers malfunction, serious and/or fatal infection can result.

The FDA reports that:

Complications related to staples that loosen or break include:

  • infection (sepsis) 15.2% of the time
  • anastomoses failure (separation of connected tubular structures, such as blood vessels or intestines) 40.2% of the time
  • Revision surgery 31.2% of the time

And a host of life-threatening injuries and complications can result when staplers malfunction, including:

  • bleeding
  • dehiscence (separation of areas that are stitched or stapled together)
  • anastomotic leakage (leakage from tubular structures, such as blood vessels and intestines)
  • hernia
  • hemorrhage
  • leaks from staple lines
  • infection(s)
  • sepsis
  • reoperation
  • death

More than 9,000 adverse event reports, FDA

Every year, for the last five years, the FDA has received more than 9,000 adverse event reports related to surgical staplers. The vast majority of these involve stapler malfunctions such as staplers that did not fire or staples did not form properly.

Between Nov. 14, 1994 and July 1, 2001, the FDA received 112 surgical stapler adverse event death reports. The reports pertain to staplers that did not fire or staples that did not form properly. There are also reports of suture-line separation from staples that did not form or fell off.

The following staplers were involved in the reported adverse events:

  • endoscopic linear cutters
  • articulating linear staplers
  • curved intraluminal staplers
  • multiple clip appliers
  • disposable autosuture

The FDA reports that the majority of deaths occurred during gastrointestinal surgeries (65%) or pulmonary procedures (19%). Other surgery sites involved the cardiac, circulatory, hepatic (system of veins and tributaries) and nephrotic

Comparison studies of surgical staples and sutures find that, while more testing is necessary, sutures are less risky than staples in specific types of surgeries.

In 2010, a study reported in the British Medical Journal, concluded that there is a significantly higher risk of developing a wound infection when a wound is closed with staples rather than sutures after orthopaedic surgery. The risk is particularly high in patients who undergo hip surgery, and the study recommends surgeons also consider using sutures in knee surgery.

Ethicon Endo-Surgical’s liability

  • In 2007, a Pennsylvania jury determined that Ethicon’s surgical stapler was defective, because it did not properly close an incision during a woman’s gastric bypass surgery.  The woman died because stomach acid leaked into her intestinal cavity.  The jury awarded $5 million.
  • In 2012, Ethicon globally recalled more than 157,000 of its surgical staplers due to concerns about firing issues with the potential to create faulty staple formation, resulting in painful and severe internal complications for patients.

The stapler “malfunctioned and failed to discharge any staples, resulting in perforation of the colon and necessitating further surgical and other medical treatment.”

 Hershberger v. Ethicon

Compensation is available and we can help

If you or a loved one suffered injury as a result of Ethicon surgical staples or staple guns, you may be eligible to receive compensation.

Damages awards may cover any or all of the following:

  • medical bills (both past and future)
  • lost income
  • pain and suffering
  • medical monitoring
  • loss of enjoyment of life
  • lifetime care costs
  • wrongful death
  • punitive damages

Estey & Bomberger is bringing Ethicon to task for designing, manufacturing, and marketing defective surgical staples and staplers that damage so many lives.

We understand that no amount of money can restore your health or bring back a loved one who died as a result of staple malfunction. However, we want to help you avoid further financial distress.

You should not have to bear the often astronomical medical and other costs associated with the failure of Ethicon’s defective medical devices, and we aim to win you the compensation you deserve.

By filing a claim, you will not only help yourself recover from the devastating effects of a surgical staple injury, you will also create a precedent that others who face similar circumstances can use to support their own case.

You have nothing to lose and everything to gain by contacting us, because there’s no charge to you until we win your case. We look forward to hearing from you. Call us: 1-800-260-7197