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.

GoldenbergLaw Partner Marlene Goldenberg Appointed To Valsartan MDL Leadership

Partner Marlene Goldenberg
Marlene Goldenberg

On May 6, 2019, New Jersey Federal District Court Judge Robert B. Kugler appointed GoldenbergLaw Partner Marlene Goldenberg to the Executive Committee as part of the leadership structure for the Valsartan Multidistrict Litigation (MDL). Marlene has previously served as the head of the discovery committee for the Abilify MDL in the Northern District of Florida and helped lead discovery, science, and briefing on over 800 Medtronic Infuse Bone Graft cases. Marlene and GoldenbergLaw look forward to holding these Valsartan manufacturers accountable for their actions.

Valsartan and Cancer

Valsartan (and other Sartan drugs such as Losartan and Irbesartan) are used to help treat high blood pressure and other heart-related conditions. Millions of Americans take this generic drug. Certainly no person taking this drug would take it knowing it could cause cancer.

Many of these medications are manufactured for generic companies overseas in China by Zhejiang Huahai and in India by Hetero Labs, among others. It has now been reported that for at least four years, many brands of Valsartan contained carcinogenic substances, such as NDMA, NDEA, and NBMA. These contaminated products were then sold to many companies in the U.S. for use in their sartan drugs. The U.S. companies failed to properly monitor and test their products before selling them to consumers.

How Does Contaminated Valsartan Cause Cancer?

NDMA is N-nitrosodimethylamine. It has been classified as a probable carcinogen and is often given to rats in medical studies to cause cancer! NDMA is so toxic it is contained in rocket fuel and has no approved uses in the United States. NDEA and NBMA have similar carcinogenic properties.

After consulting with some of the finest toxicologists in the country, the dose and duration of the exposure will help to determine if a patient’s cancer can be attributed to contaminated Valsartan. Unfortunately, most people take Valsartan daily and in high doses. Many American patients will have consumed enough NDMA or other nitrosamines to trigger genetic mutations and cancer.

The cancers linked to contaminated NDMA (the contaminant found in Valsartan) are digestive tract cancers where these substances would have been processed by the body. This includes liver, kidney, stomach, and colorectal cancer.

FDA Recall

In July 2018 the FDA recalled the first Valsartan medications, but the recalls didn’t stop there. In October 2018, certain lots of Irbesartan began to be recalled. Then in December, 2018, certain batches of Losartan were recalled as well. And the recalls keep coming almost every month. Just last week, another batch of Losartan was recalled because of toxic contamination. The FDA is continuously updating the list of recalled medications.

Have You Received A Recall Letter?

Patients around the country have and continue to receive recall notices regarding their contaminated medications. If you or a loved one has received a letter, you should talk with your doctor right away about your options. If you or one of your loved ones developed liver, kidney, stomach, or colorectal cancer after taking Valsartan or Losartan over the past four years, please contact the Minnesota defective drug lawyers at GoldenbergLaw so we can discuss your legal rights.