FDA RECALL: Serious Complications from Colorectal, Bariatric, or Gastric Surgeries? A Surgical Stapler may be to Blame

On May 16th, 2019,  the U.S. Food and Drug Administration (FDA) required Ethicon, a division of Johnson & Johnson, to recall more than 92,000 Circular Staplers that are used in gastrointestinal and bariatric surgeries.

The FDA has identified this as a Class I recall, the most serious type of recall. They have stated, “Use of these devices may cause serious injuries or death​.”

Who May be Affected

Patients who have had or may undergo gastrointestinal surgery, such as patients with colorectal cancer and bariatric patients.

The FDA Recall Notice states: “The U.S. Food and Drug Administration (FDA) is concerned by the increasing number of adverse events associated with surgical staplers and staples for internal use and is providing additional recommendations for health care providers to help protect patient safety and reduce the risk of adverse events associated with these devices.”

What are the injuries?

Potential injuries to patients include:

  • Death
  • Infection
  • Bleeding
  • Need for permanent ostomy “bag”
  • Life-long nutritional and digestive issues
  • Leak in the closure (anastomotic leak)
  • Additional surgeries
  • Need for additional closures (anastomoses)
  • Need for antibiotics
  • Need for additional imaging studies

FDA’s Reason for Recall

The FDA states:

“Complaints of  uncut washers in the stapler and malformed staples occur with their intraluminal circular staplers due to insufficient firing, which can compromise staple line integrity. When the washer is cut, confirming completion of the firing cycle, the surgeon experiences an audible and tactile crunch. Failure to cut the washer suggests complete 360-degree staple line failure.

In addition, an investigation of the manufacturing process detected a shift in a process, which occurred in March 2018 and continued through March 8, 2019, at which time the line was shut down.

The use of affected product may cause serious patient harm or death. Ethicon confirmed serious injuries. Misfiring of the stapler resulted in an additional resection — of the middle rectum in one patient and the lower rectum in another patient — during the planned resection of the upper rectum.”

What Should I Do Now?

If you or a loved one has suffered an injury after colorectal, bariatric, or bypass surgery, please contact the Minnesota Defective Medical Device Attorneys at GoldenbergLaw. With over 30 years of experience litigating complex medical device case, we will deliver the Gold standard advocacy you deserve.

Johnson & Johnson Hit With $120 Million Pelvic Mesh Verdict

A Philadelphia jury punished a Johnson & Johnson (J&J) subsidiary with a $120 million verdict over claims its pelvic mesh was defectively designed and left a woman with chronic, debilitating pelvic mesh snippain. The verdict, handed down on April 24, awarded plaintiff Susan McFarland $20 million in compensatory damages while hitting Ethicon Inc. to the tune of $100 million in punitive damages.

McFarland’s claims centered on Ethicon’s TVT-O pelvic mesh device she had implanted in 2008 to treat her urinary incontinence. McFarland alleged that the TVT-O eroded through the tissue in her pelvis and eventually had to be partially removed with a second surgery. As a result, she suffers from chronic uterine tract infections and vaginal pain so severe that she has not been able to have sex with her husband for over 10 years. The jury agreed with McFarland’s claims that the TVT-O’s defective design caused the migration of the mesh and was ultimately responsible for her injuries.

RECORD VERDICT

The verdict marked the seventh plaintiff victory and the largest award yet among the pelvic mesh cases tried in the Philadelphia Court of Common Pleas. The total awarded to plaintiffs across these seven cases now exceeds $270 million.

The verdict also comes just over a week after the Food and Drug Administration ordered the manufacturers of pelvic mesh products to stop selling and distributing the devices after the manufacturers failed to provide evidence of its long-term safety.

If you or a loved one has been injured due to a defective pelvic mesh implant, call the Minnesota defective medical device attorneys at GoldenbergLaw for a free consultation. We have the experience and skills required to help you obtain the justice you deserve.

More Than 41,000 Injuries Reported From Surgical Staplers

In March 2019, the FDA announced that it received over 41,000 adverse event reports associated with surgical staplers and internal staples. These reports may cause the FDA to assign a stricter product classification for the devices.

What’s the Problem?

The adverse event reports come from January 2011 to March 2018. Over the span of seven years, about 9,000 serious injuries, 32,000 malfunctions, and 366 deaths have been reported. However, there are also “many more” surgical stapler and internal staple malfunction reports that are inaccessible to the public.

The most commonly reported problems are:

  • Rupture of the staple line or malformation of staples
  • Misfiring, difficulty in firing, or failure of the stapler to fire the staple
  • The application of staples to the wrong tissue or using the wrong staple size

These problems can lead to:

  • Bleeding
  • Sepsis
  • Tearing of internal tissues and organs
  • Increased risk of cancer recurrence
  • Death

What’s the FDA Doing About This?

The FDA sent a letter to healthcare practitioners outlining several safety recommendations for the use of surgical staplers. The FDA plans to hold a public meeting to discuss whether to reclassify surgical staplers as Class II medical devices. A Class II medical device is the strictest classification. This would allow the FDA to establish mandatory controls to help mitigate the known risks of the surgical staplers.

Contact Us

If you or a loved one experienced a severe injury from a surgical stapler or internal staples, please contact GoldenbergLaw. We deliver the Gold standard advocacy you deserve.