Surgical Staplers
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Gastric or Bariatric Surgery Injuries Due to Defective Surgical Staplers
Surgical staples are used in bariatric and gastric surgeries in place of sutures to connect or remove internal tissue and organs. They’re also used externally to quickly close high-tension wounds. Staples are applied by a medical professional with a disposable or reusable stapler.
In March 2019, the FDA announced a plan to review and address the safety of surgical staples and staplers intended for internal use after receiving more than 41,000 adverse event reports. The reports include deaths, serious injuries, and malfunctions.
In May 2019, the FDA announced a Class I recall of over 92,000 surgical staplers manufactured by the Johnson & Johnson subsidiary, Ethicon Inc.
If you or a loved one has suffered an injury after gastric or bariatric surgery that may be due to a defective surgical stapler, contact one of the Minnesota Defective Product lawyers at Goldenberg Lauricella today. Our team will handle your case and make sure you are represented fairly.
Quick Case Facts
The Problem
In March 2019, the FDA stated it had received more than 41,000 adverse event reports associated with surgical staplers and internal staples. These reports from January 2011 to March 2018 detail 366 deaths, more than 9,000 serious injuries, and over 32,000 malfunctions related to surgical staples. Some of the most commonly reported problems include:
- applying staples to the wrong tissue
- using the wrong staple size
- problems with firing or failure of the stapler to fire the staple
- opening of the staple line or malformation of staples
The FDA has created a sweeping plan to address the safety of surgical staplers, which may mean requiring stricter product reviews of the staplers.
In May 2019, the FDA recalled over 92,000 surgical staplers manufactured by Ethicon, Inc. and warned that the staplers can cause serious injuries or death.
The Injuries
- bleeding
- sepsis
- tearing of tissues and organs
- increased risk of cancer recurrence
- death
- need for additional surgeries
- need for a permanent “ostomy bag”
- chronic digestive issues
These injuries most commonly occur after use in gastric or bariatric surgeries.
Goldenberg Lauricella Can Help
If you or a loved one has suffered a serious injury after a gastric or bariatric surgery that may be due to a defective surgical stapler, please contact Goldenberg Lauricella. We deliver the Gold standard advocacy you deserve.
FDA Class I Recall
On May 16, 2019, the FDA announced a Class I recall of over 92,000 surgical staplers manufactured and distributed between March 2018 and March 2019. All of the recalled products were manufactured by Ethicon, Inc. In issuing the recall, the FDA warned that the products can cause “serious patient harm or death” and can lead to deadly infections such as sepsis, chronic digestive issues, need for additional surgeries, and number of other serious complications.
The FDA recall notice specifically lists surgeons who have performed gastrointestinal surgeries and patients who have undergone gastrointestinal surgery as those who may be affected by the recall.
Free Consultations. Reach out to our surgical stapler injury lawyers for a free consultation. We will take a look at your case and help you to weigh your options. There is no charge and there is no obligation. Call (800) 903-1643.
Frequently Asked Questions
Surgical staples are used in bariatric and gastric surgeries in place of sutures to connect or remove internal tissue and organs. They’re also used externally to quickly close high-tension wounds. Staples are applied by a medical professional with a disposable or reusable stapler.
Firing malformed staplers can cause serious internal damage. Some of these injuries include bleeding, sepsis, tearing of tissues and organs, increased risk of cancer recurrence, and death. These injuries most commonly occur after use in gastric or bariatric surgeries.
If you or someone you know has suffered a serious injury after a gastric or bariatric surgery that may be due to a defective surgical stapler, contact one of our lawyers at Goldenberg Lauricella for a free consultation. Our team will handle your case and make sure you are represented fairly.
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