Recommendations for MoM Patients Issued by the FDA

The rising number of cases filed by patients against hip implants manufacturer have piqued the interest of many orthopedic experts, medical industry observers say. Metal-on-Metal hip devices have unique risks which may expose patients to a variety of health problems, according to the Food and Drug Administration (FDA). There are several recommendations given by the FDA to help patients and health care providers manage MoM hip implant problems.  Patients need to coordinate with their surgeons to ensure that they report the symptoms that they encounter. There are many cases filed by patients who have experienced some of these complications but the Biomet manufacturer motions to dismiss these cases.


Patients who experience the following symptoms may need to report it to their health care providers immediately:

-      Hip or groin pain

-      Difficulty in walking or limping

-      Numbness

-      Redness and swelling

-      Signs of worsening symptoms


These symptoms may indicate that the patient is already experiencing severe complications of the metal ions released by the metal hip implant. However, some have experienced other health problems that may be away from the hip implant. The worsening symptoms that may be related to the kidney, heart, skin, thyroid gland or nervous system may need to have a re-diagnosis. Although these problems are far from the hip, they may still be related to the metal particles from the implant. These are hypersensitivity reactions from the metal ions.


These hypersensitivity reactions are still highly unpredictable as there are limited data on their pattern and effect. Men and women may react differently to various amounts of metal ions in their blood. Some may develop symptoms after being exposed to small amounts of metal particles while some may build-up tolerance and will only develop symptoms after reaching critical levels. This varying degree of sensitivity also contributes to the difficulty in predicting the patients that may be develop hypersensitivity reactions. However, there are some risk factors that may lead to the development of these health problems.


The following patients who have these risk factors are advised to have frequent follow-up with their health care providers, as recommended by the FDA:

-      Female

-      Have bilateral implants

-      Kidney problems

-      Have high levels of physical activity

-      Severely overweight or obese

-      Problems with the immune system

-      Metal hip implants not placed correctly

-      Taking high doses of corticosteroids

-      Has resurfaced hip implants with small femoral heads


Individuals with MoM hip devices who have developed severe complications believe that their implant may have been the cause of their problems. Some of them asked a Biomet hip lawyer to help them file their case.

 


URL References:

fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/MetalonMetalHipImplants/ucm241766.htm#4

fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm335775.htm

 

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