New Issues with ASR Implants
Thousands of patients who received the DePuy ASR hip implants have suffered from chromium and cobalt poisoning and required revision surgery. But, the damage has extended even further for some patients. For some patients the damage to bone, muscles and nerves from the faulty implants, which can shed tiny metallic particles, has left them permanently disabled. To make matters worse, that damage can also complicate a replacement operation. So just how serious are these newly reported patient health issues?
Permanent Damage From a Defective Product
One such patient, a 56-year-old woman, remains on disability and continues to walk with a cane, a year after her ASR implant was removed and replaced. The pain is so excruciating for her that she is unable to remain standing long enough to cook a meal. “I have been told that I have to be prepared that it will be like this for the rest of my life,” she said.
Faulty Screening Process
What makes the permanent damage all the more frustrating for the woman mentioned above, along with thousands of other patients, is that their disability was caused by a hip component that was a critical part of another device that the F.D.A. had never approved for sale. The problem stems from the fact that current rules do not require device producers to notify the F.D.A. when they bundle together components from approved and unapproved devices, Mark Melkerson, an FDA official, acknowledged. As a result of these rules, tens of thousands of patients, like the woman mentioned above, were left with an ASR implant containing an unapproved part. All this begs the question, why do the rules exist as they do?
The FDA recently issued an internal agency review which found numerous flaws with the process. Changes are currently proposed, but that doesn’t change the fact that effective rules weren’t in place when they needed to be. It also doesn’t change the fact that permanent damage has already been inflicted on countless patients who received the ASR implants.
Temporary damage is bad enough, but permanent damage is irreversible. Patients like the 56-year-old woman, were under the impression that they would be improving their health with a new implant, not leaving surgery with permanent health issues. In fact, she said, “My doctor said that this was a new design that was particularly good for young people.”
But things did not go as planned for her or for countless other patients. It would appear that not only is DePuy to blame, but the FDA as well. If you are suffering from permanent damage, you deserve to know more about this implant and your legal rights.
A partner with Childers, Schlueter & Smith, LLC, Richard Schlueter has spent his career representing individuals and families who have been harmed as the result of wrongful conduct by others. Recently, Richard was selected for inclusion into the Nation’s Top 1 percent of lawyers by the National Association of Distinguished Counsel (NADC).