Attention: Seeger Weiss is no longer accepting case evaluations for Aesculap knee replacements.
The ongoing problems with faulty knee replacements continue.
Most recently, more than two dozen plaintiffs have filed lawsuits related to Aesculap Implant Systems against the implant manufacturer B. Braun.
According to the lawsuits, the manufacturer hid problems with its joint replacement implants from regulators, and failed to warn consumers and medical professionals about the increased likelihood of failure.
FDA reports show an unusually high number of failures related to complications with the implant’s ability to stay bonded. Problems are related to Aesculap Systems that are covered in a ceramic coating. Though no official cause of failure has been identified, many believe the problem is linked to de-bonding, which means implants aren’t able to bond or set properly because of the ceramic coating on the implant.
Like many modern day knee replacements on the market, the Aesculap system utilizes the Advanced Surface Technology ceramic coating, which was originally thought to be safer than the metal implants that have come under significant scrutiny. Manufacturers claim these ceramically coated implants last longer than traditional implants, but there is evidence this is not the case and many recipients have experienced device failure when their implants failed to adhere properly to the bone.
Aesculap Knee Replace Implants Rushed to Market
It should be noted, Aesculap systems were rushed to market through the FDA’s 510(k) approval process.
This process allows for the faster than usual approval of drugs and medical devices if the manufacturer is able to demonstrate similarities to existing products already approved for the market. Products approved through this program undergo fewer clinical trials and are essentially tested through real-life applications.
Though the program offers some benefits, it has led to a number of adverse events and ultimately, to several products being recalled from the market after approval.
Additionally, there may be evidence that Aesculap manufacturer B. Braun failed to warn consumers and medical professionals of the risk of failure of its knee replacement implants, despite being fully aware there could be a problem with the ceramically coated products.
Surgeons Report Lack of Adhesion for Aesculap Implants
In most cases, when revision or removal of a knee replacement implant is needed, the surgeon must saw through the cement used to adhere the implant to the bone.
Several surgeons performing revision surgery on patients with Aesculap implants have reported they were able to remove components by hand, with no sawing or cutting, or by simply tapping the components with a mallet. As a result, surgeons have concluded a problem exists with the Advanced Surface Technology ceramic coating used in Aseculap knee replacement procedures. There is a concern that this surface does not adhere properly to bone cement, which is often used in knee replacement surgeries. This ultimately results in loosening of the device. In many such cases, revision surgery is required to replace the implant or to properly secure it using a mechanical bond (e.g, bone screws) to ensure adequate fixation and stability in the knee.
Efforts are now underway to gather information about failure of the Aesculap systems
If you or a loved one has been affected by problems with the Aesculap knee replacement implants, or you believe you are experiencing issues with your joint replacement device, we want to know about it.