In August 2010, a hip recall was issued upon the all-metal hip implant of DePuy Orthopedics, the ASR XL Acetabular System and the ASR Hip Resurfacing System. 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 Orthopedics is part of the Johnson & Johnson family of companies. The ASR hip system was approved for US market use two years after it was first released in 2003.The implant went through the 510 (k) approval process of the FDA. Devices that went through the process do not have to undergo premarket trial.
There are about 93,000 devices implanted on patients all over the globe. The implants were said to be efficient and suitable for patients and doctors alike. However, studies done recently showed a different result. Device-related complications were experienced by recipients after the implantation. The design of the new line of devices was thought to be the reason of the complication. 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. This may result to revision of surgery especially if the condition is not catered to immediately.
Another complication seen on recipients of the device is metallosis or metal toxicity. This condition occurs when parts of the metal flake off, causing inflammation in the tissues surrounding device. Patient’s blood test result reveal excessive amount of metal ion.
Nearly one in every three ASR hip replacements fail in six years, says the National Joint Registry for England and Wales.Of the 2,100 patients the registry has been monitoring, 29 percent of the patients who received the device six years ago need to have it replaced. The device that was planted half a decade ago showed symptoms of failure in 17 percent of the patients.
The British Hip Society held its annual meeting last March 2011. During their discussion, the group presented a faster-than-anticipated failure rate of the ASR hip. The decline rate ranges from 21 percent in four years to 49 percent in six years, media reports say.
There is a heightened concern about all-metal hips in the United States and all over the globe. With the company’s “commitment to patient safety” and the non-stop complaints thrown unto the device, DePuy orthopedics ordered a voluntary hip replacement recall. Additionally, patients and doctors are advised to immediately report any symptom of a failing device. Patients who were affected of the failing device are aiming for a DePuy hip settlement for the complications they suffered.
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/