DePuy Orthopedics has voluntarily issued a recall on their hip implant, the ASR XL Acetabular System and the ASR Hip Resurfacing System, in August 2010. It was ordered due to the health issues concerning the safety and effectiveness of the device. An FDA official urges smart regulation in the wake of the DePuy recall , as reported during the recently concluded Biotech conference.
 
DePuy Orthopaedics is a subsidiary of Johnson & Johnson, Inc. The company introduced its ASR hip system in 2003 and was given U.S. premarket approval in 2005. The 510 (k) approval process of the FDA gave the permission for the release of the device.Under the policy, devices need not undergo clinical trial before it is marketed.
 
The number of implants given to patients worldwide could reach 93,000. Both patients and doctors will be benefited for the product was thought to be effective and convenient for them. However, studies done recently showed a different result. Patients experienced complications that were thought to be caused by the device. The cause of the complication is attributed to the design of the new line of devices.  Some of the possible complications brought about by the device are premature loosening of the hip implant, dislocation of the device, and possible fracture of the bone surrounding the implant. If these conditions are not corrected immediately, revision surgery is most likely to happen.
 
Metallosis or metal toxicity is another complication may be experienced by patients. This condition occurs when parts of the metal flake off, causing inflammation in the tissues surrounding device. Results of blood tests show high level of metal ion in the circulatory system of the patient.
 
There is an estimation made by the National Joint Registry for England and Wales that roughly one-third of the ASR hip replacements fail after six years.  The registry is following 2,100 patients and of them, 29 percent need to undergo another surgery after six years.  For patients who received the device for five years, a failure rate of 17 percent was detected.
 
In March 2011, the British Hip Society had its annual meeting.  The British Hip Society held its annual meeting last March 2011.  On the 3rd month of 2011, the annual meeting of the British Hip Society was conducted. During their discussion, the group presented a faster-than-anticipated failure rate of the ASR hip.  According to reports, the results of the failure rate were 21% at four years and 49% at six years.
 
There is a heightened concern about all-metal hips in the United States and all over the globe. A DePuy hip replacement recall was issued by the company as an answer to the complaints they are facing and to uphold their “commitment to patient safety.” For both patients and doctors, it is highly recommended that symptoms of failing device be reported immediately. Affected patients may also claim for DePuy ASR hip settlement for the trouble the device has caused.
 
Reference:
depuy.com/asr-hip-replacement-recall
first4lawyers.com/faulty-depuy-hip-replacements-personal-injury-compensation-viable-as-national-joint-registry-publishes-new-revelations-in-report/
petermcdonnellsolicitors.wordpress.com/2011/08/15/depuy-hip-failure-rate-as-high-as-49-according-to-uk-doctors/

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