Ethicon Stapler Injury Lawyers Our firm is investigating injuries caused by Ethicon Endo-Surgery, Inc’s gastric bypass stapler. If you or a loved one experienced staple line disruption, infection or other serious complications following gastric bypass surgery, an Ethicon Stapler could be to blame. You may be entitled to compensation for your medical bills, lost wages and pain and suffering.
The Ethicon Stapler has been associated with serious injuries, including infections and deaths. Adverse Event reports to the U.S. Food & Drug Administration (FDA) indicate that the Ethicon Stapler is more likely to misfire than other devices on the market. When this occurs, patients can experience injury, sepsis, shock and even death. If you or a loved one has been a victim of such complications, our injury lawyers want to hear from you today, that’s why we have Surgical Staples Misfiring and Implantable Staples Malformation Attorney Lawsuit.
Our Ethicon Stapler injury lawyers know how devastating these complications can be. We are working right now to make sure Ethicon Endo-Surgery and its parent company, Johnson & Johnson, are held accountable for the misery this stapler has caused. If you believe you or a loved one suffered an injury because of this device, we urge you to contact our Ethicon Stapler lawyers today to protect your legal rights.
Ethicon Stapler Complications after Gastric Bypass Surgery
Gastric bypass surgery is one of the most popular weight loss surgeries in the U.S. In this procedure, the stomach is surgically reduced, and the calories a patient absorbs during a meal are drastically lessened, allowing the individual to drop a large amount of weight fairly quickly.
To make the stomach smaller, surgeons separate the small upper portion of the stomach from the larger lower portion using staples that have been created solely for use during gastric bypass surgery. If the staples do not seal properly, this can cause leakage into the abdominal cavity, separation of the areas that were stapled, and other adverse events.
The FDA has received more than 9,000 adverse event reports related to surgical staplers. Ninety percent of these reports involved malfunctions wherein the staplers did not fire or did not form properly. To date, the FDA has received approximately 100 reports of deaths related to surgical staplers.
Ethicon began manufacturing its gastric bypass stapler in 1999. The company now controls approximately 2/3 of the gastric bypass stapler market. More than 177,000 Americans undergo gastric bypass surgery every year, the majority of which use the Ethicon Stapler.
Since it came on the market, however, Ethicon has received numerous reports of staple line failures attributed to its device. In many cases, the staples failed to close around the patient’s tissue or the stapler failed to release the staples resulting in leakage. Among the patients who died, the stapled tissue typically had begun leaking fluid or blood, leading to infection.
Leakage of the stomach contents due to staple line disruption can lead to the development of sepsis and peritonitis, both life-threatening conditions. Staple line failure requires patients to undergo additional surgeries, and even then, recovery may not be complete. Some patients injured by a defective Ethicon Stapler have had to undergo colostomies, and in
Some injuries that can occur when an Ethicon stapler misfires include:
- Dehiscence (separation of areas that are stitched or stapled together)
- Anastomotic leakage
- Leaks from staple lines
Rather than addressing the problem in the design of its stapler, Ethicon has continued to blame surgeons. When defending itself in lawsuits, the company often claims that an improperly sized staple was used in a procedure. But our investigation into such injuries has determined that surgeons have no way to accurately determine stomach tissue thickness in order to always choose the proper staple cartridge.
March 8, 2019 FDA Letter to Healthcare Providers States: Surgical Staplers, Implantable Staples Leading to Patient Injuries
In a letter sent to health care providers on March 8, the U.S. Food and Drug Administration indicated that it had received a large number of adverse event reports on surgical staplers and staples. The FDA said this number was trending up in recent years. While the FDA said that many of the reported complications were related to the staplers, the staples themselves might also be defective.
Surgical stapling can be used externally and internally on patients during medical procedures. Both types of staples — external and internal — are considered medical devices, as are the staplers used to apply the staples. Internal (implantable) surgical staples are often used during gynecologic, gastrointestinal, and thoracic surgeries, as well as many other types of surgery. Surgeons use stapling for removal of organs, for transection of organs and tissue, and to create connections inside the body.
The FDA recently finished an analysis of adverse event reporting related to surgical staplers and implantable staples and said that it was concerned about the rising number of reported complications from the devices. The FDA analyzed the two devices together and stated that it had received more than 40,000 reports regarding adverse events between January 1, 2011, and March 31, 2018.
Out of the total reports, 32,000 described situations of malfunction, 9,000 described instances of serious injuries to patients, and 366 indicated that patients died from complications. The FDA said the majority of reports were related to staple lines opening or malformed staples, misfiring and difficulty firing the staples, and lack of firing.
In its letter to medical providers, the FDA said it believed that many of these reports were due to problems with the staplers because functioning staplers were necessary for properly formed staples. However, the staples could also be defective, leading to patient injuries. The issues cited by the FDA — opening of staple line, staple malformation, firing issues — can be attributed to defects in the staples in addition to defects in the staplers. The FDA noted that difficulty firing the staplers could be due to issues with the staples.
The FDA said that when the stapler and/or staples malfunction, patients might require prolonged surgeries or more surgeries than originally planned. The necessity of longer or unplanned surgeries leaves patients vulnerable to a number of serious injuries, including:
- Bleeding events
- Formation of fistulas
- Tearing of tissue or organs
- Higher risk of cancer recurrence
In addition, in its letter of March 8, 2019, the FDA noted that the 41,000 reports it received on stapler and staple complications do not represent the complete picture. During the same timeframe analyzed by the FDA (January 2011 to March 2018), a large number of reports on malfunction were also submitted through a different system, called the Alternative Summary Reporting program. In so noting, the FDA said that surgical staplers and implantable staples are not currently eligible for Alternative Summary Reporting. The FDA did not say how many reports were potentially submitted this way, but the agency said it was in the process of analyzing those and would publish the results as soon as they were available
Because of the potential for serious injuries to patients, the FDA is drafting recommendations for labeling changes for implantable staples and surgical staplers. The FDA also advised that surgical stapling is not appropriate for all patients, and surgeons should consider other options when dealing with certain surgical situations and patient histories.
Legal Help for Victims of Ethicon Staplers
If you or a loved one suffered staple line disruption that led to serious complications following gastric bypass surgery, an Ethicon stapler may be to blame. If so, you have valuable legal rights.
Our Ethicon Stapler injury lawyers will do everything legally possible to make sure you are fairly compensated for your suffering. Please fill out our online form, or call 1-800-YOURLAWYER (1-800-968-7529) to discuss your case with one of our Ethicon Stapler injury lawyers today.