The Committee will be examining immunological responses to metal-containing products regulated as medical devices. As we know, the vast majority of patients experience no reaction to the metals in devices. However, for those affected by “unexpected or heightened biological responses to the implant” the symptoms may be local or systemic and may be life-changing. Too often metal hypersensitivity is just seen as a rash. Patients reacting to a device may report over 30 symptoms, however, when the case report is finally published only “pain” and “dermatitis” or “skin rash” are recorded as symptoms.
MELISA will be sharing case histories and background data. We will also stress how important it is that full disclosure of the constituent metals in implant alloys is made easily available to practitioners and patients alike. The importance of detailed disclosure is illustrated in the case below.
If you have experienced side-effects after receiving a metal-containing medical device, or have treated a patient who was affected please let the FDA know. You can submit your comments until December 16 HERE
Statement from FDA Commissioner Scott Gottlieb, M.D. and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on efforts to evaluate materials in medical devices to address potential safety questions. FULL ARTICLE