As a defective hip implant law firm, we noted buried deep in the FDA’s website a recent order for post -market surveillance studies to manufacturers of metal-on-metal hip systems. This was issued over a year after the UK’s equivalent of the FDA, the Medicines and Healthcare Products Regulatory Agency (MHRA) issued a similar advisory. The FDA’s warning was sent to twenty-one different manufacturers after startling data revealed an alarming number of metal-on-metal hip implants simply fail over time.
What is troubling to me, as a Miami hip replacement injury lawyer, is how the information gets disseminated to consumers who mistakenly believe that the FDA has tested these products before they were approved for use. Current medical device regulatory policies allow implants like metal-on-metal hips to be approved for sale with virtually no clinical testing in patients. Currently in the US alone, over 250,000 hip replacement procedures are performed annually.
In typical FDA fashion, the Agency has left the decision as to clinical evaluation and reporting methodology completely to the manufacturers. This is in essence the same as asking football game to be officiated by the team owners rather than by impartial referees–but with life-altering consequences. For the first time, the FDA is simply “requesting”, not “requiring”, that manufacturers determine how often their devices fail.
Our Miami medical malpractice lawyers recommend that anyone considering undergoing a hip implant procedure using a metal-on-metal system to carefully consider the benefits and risks. Specifically, metal-on-metal hip implant systems are not for everyone, especially patients with kidney problems, metal allergies, suppressed immune systems, women of childbearing age or those receiving high doses of corticosteroids. There have been marked increases in failures for patients with smaller body frames.
For those who already have metal-on-metal implants or are not sure what kind of hip implant they have we recommend an immediate follow up with your surgeon, especially if you are experiencing any of the following symptoms: hip/groin pain, local swelling, numbness or changes in your ability to walk.
For more information about the FDA and its concerns about hip implants read this.