Aesculap Knee Replacement Lawsuit
Joint replacement devices, including knee replacements, have long been considered a mixed bag in the medical community. When functional, joint replacement devices provide added stability, restoration of mobility, and an improved quality of life for patients who have developed problems from joint use over the years.
Unfortunately, though, many have found these positive benefits to be short-lived. And in some cases, the pain associated with joint replacement surgery recovery never ends and recipients experience nothing but problems from the point of their procedure onward.
For many Aesculap implant recipients, pain and complications could be linked to device failure caused by a problem with the coating on the implant, which prevents cement from bonding or setting properly.
FDA Compiling Information on Aesculap Systems
The Food & Drug Administration monitors adverse events related to medical devices and knee replacement devices are no exception. When the agency notices patterns or a higher than usual number of adverse events related to a product, it is obligated to alert the public and when necessary, has the authority to issue a recall for a device or product it deems dangerous.
There have already been numerous reports filed with the FDA concerning Aesculap systems. Complications related to the device include:
- Severe pain
- Decreased range of motion
- Joint instability
- Need for revision surgery
- Extensive rehabilitation
- Permanent bone loss and muscle damage
- Infection and swelling
Recipients have also reported the need for follow-up or revision procedures to correct problems with their implants. These procedures are riskier than the initial placement surgery and often require extensive physical therapy after placement.
Additionally, many Aesculap recipients have been forced to miss time from work due to the pain and complications they are experiencing.
Why are Aesculap Knee Replacement Implants Failing?
No official cause for failure has been given, but many surgeons performing revision procedures are concerned about a lack of bonding cement in the faulty implants, which they believe is caused by the ceramic coating on the implant.
The ceramic coating used in Aseculap knee replacement procedures is called Advanced Surface Technology. 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 insure adequate fixation and stability in the knee.
Several different Aesculap knee replacements have been affected by de-bonding issues, including:
- VEGA System
- Columbus Knee System
- Advanced Surface Technology
- Columbus AS Revision Knee System
- EnduRo AS Knee Revision System
- univation X
What Can Be Done If I’m Experiencing Problems with My Knee Replacement?
The first thing you should do if you are experiencing problems or you have concerns about your knee replacement is to contact your doctor. He or she can evaluate the condition of your implant and offer medical guidance based on an assessment of your symptoms or concerns.
It’s also important you speak with someone who understands the extent of problems faced by the joint replacement industry and who can answer any questions you might have about compensation. As a knee replacement recipient, you could be eligible for money to offset the cost of medical care, follow-up procedures, lost wages, and pain and suffering.
Like many medical devices, the Aesculap systems were approved in a short period of time based on the FDA’s 510(k) program. This program alleviates the need for extensive clinical trials and allows manufacturers to gain “automatic approval” for their product as long as they are able to show there is something similar already on the market. This program has brought many much-needed products to market quickly and conveniently, but it has also led to approval of a substantial number of products that later proved dangerous.
In addition to concerns about adequate testing of the Aesculap systems, there is also evidence the implant’s manufacturer, B. Braun, hid problems with its joint replacement devices and promoted the products to surgeons even though they knew there was risk for failure.
Currently, there are efforts underway to gather information about failed Aesculap implants and to take legal action on behalf of recipients who have experienced device failure.
If you or a loved one has suffered pain or needed to undergo expensive and risky revision surgery after the failure of an Aesculap knee replacement implant, we want to know about it. Recipients who suffered because of their joint replacement devices can receive money for their pain, suffering, cost of medical care, and time missed from work.
For more information or for a free case evaluation, contact us.