Fda panel‘s possible solutions to hip implant problems
-
Upload
william-davis -
Category
News & Politics
-
view
1.288 -
download
0
description
Transcript of Fda panel‘s possible solutions to hip implant problems
Metal hip implants become popular in the medical industry as thousands of patients reported improvements in mobility and flexibility of their hips and lower extremities, medical industry publications report. However, they are also associated with debilitating adverse events which later caused the recalls of some of the top metal hip replacements such as the Depuy ASR Hip Replacement System and the recent device recalls by Stryker. The FDA panel held a two-day public hearing to address some of these controversial issues and important questions were discussed.
The good news is that the elevation of metal ions in the body, which is deemed as one of the most serious complications of metallic hip implants, may be monitored through blood testing. Also, they may safely be performed to metal hip recipients regardless of their symptoms. However, the downside is that medical experts still do not know how to interpret their findings and how to incorporate it into the treatment of affected patients. Moreover, there is also the risk of contaminating the blood samples causing faulty readings.
Magnetic Resonance Imaging (MRI) has also been promoted to detect the severity of the fracture or dislocation of the implanted hips, but this type of technology is not always available and there may only be few medical professionals who are adept at interpreting them.
Metal sensitivity testing is also discussed as an important step to be carried out before the implantation as this checks if the patient is intolerant to metals. However, negative skin tests for metal sensitivity do not always mean there is no risk for the underlying tissues to develop an allergic reaction.
In time, especially when the patient does not limit his or her physical activities to protect the stability of the implant, some metallic debris coming from the surface of the prosthesis are introduced into the margins of the implant or into the bloodstream. Not all patients develop a reaction to this, but majority experiences pain, inflammation, and infections.
Because of the severity of the complications, experts could not point out a particular group of patients in which they would recommend metallic hip implantations as the treatment of choice. Patients should be properly and adequately notified of the possible health risks and failure of the metallic implants. Also, patients need to be informed of the lifestyle changes he or she has to adapt into after the surgery.
After the procedure, all patients need to be subjected to annual physical assessments. But when problems are detected, patients should be seen at least twice in a year until the need for reconstructive surgery is determined and performed. Furthermore, recipients need to look up the updates of hip recall law for possible compensations they might be entitled to.
Source:http://www.hiprecalllaw.zoomshare.com/2.shtml
References:fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/OrthopaedicandRehabilitationDevicesPanel/UCM309302.pdfonline.wsj.com/article/BT-CO-20120627-713779.html