Surgical Staples Recalls: Lawyers Reviewing Product Liability Cases Nationwide
In recent years, tens of thousands of surgical patients may have been exposed to dangerous and defective surgical staplers, which have been recalled due to a risk of surgical complications and severe injuries that may result from malformed surgical staples or misfires.
The lawyers at Saiontz & Kirk, P.A. provide free consultations and case evaluations to help individuals throughout the U.S. determine whether they may have entitled to financial compensation through a surgical staples recall lawsuit, as many of these problems could have been avoided.
While complications have been linked to a number of different products in recent years, a shift in the manufacturing process for recalled staplers in March 2018 may have further increased the risk of problems.
Earlier this year the FDA announced a recall that impacted more than 100,000 surgical staplers found in operating rooms nationwide, which had been linked to problems with insufficient firing. The action was taken shortly after the agency issued new rules and guidelines designed to improve the safety of surgical staples used internally during procedures nationwide.
In March 2019, the FDA reported that the agency had received more than 9,000 reports involving a serious surgical staples injury, including at least 366 deaths, which were linked to:
- Staple Malformations
- Stapler Misfirings
- Stapler Firing Failures
- Internal Injury and Organ Perforation
Overall, the FDA noted that it has received more than 41,000 adverse event reports involving problems with surgical staples since January 2011. Among the most common problems reported were opening staple lines, staple malformations, staple misfirings or staples being too difficult to fire. This can lead to additional surgeries, bleeding, sepsis, infections and internal organ damage.
They can also result in the need for ostomy bags, anastomotic leaks, nutritional problems, digestive problems and other complications that can haunt a patient for the rest of their lives.
In response to the near-chronic report of problems and a number of surgical staples recalls, the FDA proposed to change their classification of the devices from low-risk to moderate-risk in April 2019.
The agency also issued a draft guidance which suggests manufacturers have failed to adequately warn the medical community and patients on the potential risks, complications and contraindications of surgical stapler use.
The change from low risk to moderate risk would mean that future surgical staplers would have to undergo premarket notification before being sold on the market. However, it would still allow staplers to go through the 510 (k) fast-track approval process, meaning they will only have to show that they are “substantially equivalent” to already approved devices.
Surgical Staples Lawyers Provide Case Evaluations
The product liability lawyers at Saiontz & Kirk, P.A. are currently reviewing potential claims nationwide from individuals who have suffered injuries due to surgical staples complications in recent years.
Financial compensation may be available to those who suffered:
- Internal Bleeding
- Internal Leaks
- Internal Organ Damage
- Sepsis or Other Infections
- Additional Surgery To Remove Malformed or Misfired Staples
Request a free consultation and claim evaluation. All claims are handled on a contingency fee basis, so there are never any out-of-pocket expenses and no fees unless a recovery is obtained.