January 4, 2012
DePuy Orthopaedics, Inc. is recalling all of its ASR XL Acetabular Hip Systems and ASR Hip Resurfacing Systems after years of complaints that the product is defective. The prosthetic systems have been in use since 2003 and, even before their product was recalled, lawsuits began. The suits alleged that DePuy manufactured a defective product and failed to properly warn patients and doctors of all the problems they had been made aware of. Patients who have received these implants have reported many side effects, including:
- Metal sensitivity
- Loosening of the prosthesis
- Bone fracture
- High metal ion levels in blood
Many patients must undergo painful revision surgery to have the implant removed and replaced. Approximately 13% of patients with the ASR XL Acetabular System must undergo surgery again within five years, according to DePuy. That rate is approximately 12% for ASR Hip Resurfacing System patients, DePuy said. These revision rates are much higher than other hip implant systems on the market. Generally, hip implant prosthetics are designed to last approximately 15-20 years.
The recalled DePuy hip implant systems feature a metal acetabulum, or hip socket, and a metal cup or ball. Currently, it is unclear what serious, long-term health effects could result from the use of these types of metal on metal hip implants. Patients who have received metal on metal hip implant systems have reported numerous medical complications, including popping, grinding, pain, infection and lack of mobility. Many patients have reported the growth of cyst-like formations, or tissue masses, under the surface of the skin. When biopsied by medical professionals, these cysts and the surrounding soft tissue have been found to contain high levels of metal ions.
Britain's Medicines and Healthcare Products Regulatory Agency has warned that metal on metal hip implants can produce metal shavings. This metal debris forms when the metal socket and the metal ball of the hip implant come into contact. The agency says this metal debris can kill soft tissue in the body and adversely impact the effects of a hip revision surgery.
Moreover, Britain's Medicines and Healthcare Products Regulatory Agency has set forth specific recommendations for those patients who have had metal on metal hip implants. First, these patients should be monitored at least every five years or more frequently if they have pain or other symptoms. Second, patients who have received metal on metal hip implants should be monitored for high cobalt and chromium ion levels in their bloodstreams. Finally, if these patients develop soft tissue reactions, fluid collections or tissue masses, physicians should consider revision surgery. The agency reached developed these recommendations after consulting with orthopaedic surgeons and considering information provided by the National Joint Registry for England and Wales.
While complaints about these products began as early as 2008, it was not until March 2010 that DePuy first addressed these complaints and then August 24, 2010, when DePuy issued a recall of the hip implants.
Litigation against DePuy Orthopaedics, Inc. and Johnson & Johnson is currently beginning in state and federal courts across the nation. If you or someone you know has been has a DePuy hip implant it is essential that steps be taken to protect the rights of those effected. Before taking action, consider these steps:
Determine Whether You Have a DePuy Implant
You may not receive a notice that you have a defective implant. DePuy did not keep records of the individuals who have received their ASR XL Acetabular Hip Systems or ASR Hip Resurfacing Systems. However, your orthopaedic surgeon may inform you that you have received one of the recalled devices.
If you are uncertain about whether or not you have received one of the recalled implants, The Law Offices of O'Mara and Padilla may be able to help.
Do Not File a Claim or Provide Any Information to DePuy
If DePuy is notified that you have one of the recalled devices, you may be asked to contact DePuy to establish a claim. You are not required to file a claim with DePuy to pursue your legal rights. In addition, you should not sign any documents purporting to release DePuy from its legal responsibilities.
DePuy may offer to pay some portion of a revision surgery expense. However, DePuy is likely limiting their contribution to what they independently determine is reasonable. DePuy will not compensate you for your lost wages, your pain and suffering or your future medical needs.
It is important for you to know your legal rights. In this case, the law allows you to seek the total billed amount of your medical treatment, all of your lost wages, the full value of your future medical needs, in addition to your pain and suffering damages.
Protect Your Legal Rights During Revision Surgery
If you have been told that you require revision surgery it is essential that your protect your legal rights by retaining legal counsel. The Law Offices of O'Mara & Padilla have vast experience handling product defect litigation and understand the complexities of these types of cases. We can protect your legal rights during the revision procedure and recovery process. You can focus on getting well while we maintain the fight to protect your interests against DePuy.