Metal-on-Metal hip devices started to raise safety concerns after issues related to their use surfaced, news reports say. There were even several DePuy ASR XL Acetabular Systems that were recalled because of the high failure rate and complication reported by patients, according to the Food and Drug Administration (FDA), the implant was voluntarily recalled by DePuy Orthopedics after the complications started to surface. Patients who have been implanted with this recalled hip device may have fear for their safety and health. Orthopedic doctors continue to monitor the number of complications related to the use of these prostheses.
The FDA has included the complications related to the use of these devices in the product safety information that they have released. Monitoring of symptoms is the best that the patients may do when they already have the recalled hip device. Early detection may give way to early treatment to prevent the damage from spreading. The wear and tear of the of the prosthesis may lead to the high concentrations of metal ions in the blood. Reducing the adverse events related to these implants may be done by surgeons through looking at the patients that would best benefit from this of type prosthesis.
Patients may or may not be affected by the chromium and cobalt ions released by the worn out device. Depending on the sensitivity of the patient to the cobalt and chromium ions, adverse reactions may vary. Soft tissue damage may result from these adverse reactions. Eventually, the device might loosen and fail because of these localized lesions. The risk of adverse events may be affected by the following factors:
- Age – this problem is more prominent among younger men and women.
- Gender – this complication is more common among women.
- Weight – overweight individuals may experience wear and tear faster because the added weight adds more pressure to the joints.
- Diagnosis – more damage may ensue depending on the diagnosis of the patient.
- Activity level – activities that may add pressure to the joints such as running and jumping may increase the risk.
Patients may follow-up on their symptoms with their orthopedic surgeons if there is evidence of device failure. MedWatch or the FDA Safety Information and Adverse Event Reporting Program helps in monitoring the reports of health care providers, patients and medical device manufacturers. Although patients are not obligated to report these adverse events, they are encouraged to do so in order to build a database on these devices. The risk of metal toxicity problems may put the health of patients in serious condition.
URL References:
fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/MetalonMetalHipImplants/ucm241744.htm
medscape.com/viewarticle/777801
bmj.com/content/344/bmj.e1410
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