The recall made by one of the biggest device manufacturers in the United States has raised concerns over the safety of their products, news reports say. DePuy Orthopedics voluntarily recalled their DePuy ASR TM Total Hip System due to higher than expected failure rate that have resulted to a secondary surgery, according to the Food and Drug Administration. The recall was made on August 24, 2010 after the unpublished data from the United Kingdom joint registry indicated that there is 13 percent chance for revision among patients with this prosthesis within five years. For this reason, the number of cases participating in the DePuy ASR multidistrict litigation continues to grow.
The recall of the said product from DePuy was due to the problems that were experienced by a number of individuals who have had the implant. The design for the ASR system may prove to be the downfall, even though the use of an all-metal ball and cup was thought to be more durable than using metal and ceramic or polyethylene. Orthopedic experts believe that the risks faced by patients are more unique when they have this all-metal hip implant because of the metal particles released from the wear and tear of the prosthesis. The metal used for these implants were chromium and cobalt.
Patients may or may not react to the high concentrations of chromium and cobalt in the blood. However, there are several documented adverse effects that may occur because of the metal toxicity. There are even studies that link chromium and cobalt as possible carcinogenic metals. The possible occurrence of adverse local tissue reaction is possible and the release of metal ions may also lead to other systemic effects. The FDA has even listed the following possible systemic reactions that patients may experience:
- Skin rash or general hypersensitivity reaction
- Heart muscle problems
- Sensory and neurological changes
- Change in physiological status like depression
- Impairment of renal function
- Thyroid problem
Men and women who do not experience the abovementioned problems and there are no evidence that there is a problem with the hip, then the surgeon may not require blood testing for metal ions or soft tissue imaging, as recommended by the FDA. However, if these reactions are present, then patients may need to follow-up these symptoms with their orthopedic surgeon. The FDA continues to monitor these problems in order to update the existing information. The DePuy hip recall was initiated by the manufacturer to avoid the number of cases filed by patients to rise.
URL References:
medscape.com/viewarticle/777801
fda.gov/medicaldevices/productsandmedicalprocedures/implantsandprosthetics/metalonmetalhipimplants/ucm241770.htm
bmj.com/content/344/bmj.e1410
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