The Food and Drug Administration might soon be imposing stiffer rules on a certain medical device.
It was announced today that the FDA would meet on June 27 and 28 to consider whether or not they should require metal on metal hip implants to face additional testing if such devices aim to gain approval by the organization. This comes on the heels of numerous complaints regarding the devices.
Many people have endured the failure of such devices over the past few years, leaving the implants with a reputation of having a higher than acceptable rate of failure. Devices made from other materials have not broken at the same rate.In fact, the National Joint Registry of England and Wales initiated a study which showed that 6% of recipients of a metal on metal implant device needed corrective surgery, compared with the more commonly accepted 2% that is normal with ceramics or plastics.
Last May, the FDA ruled that manufacturers needed to provide more data on these devices to demonstrate their safety. Studies have also shown that metal devices can increase the level of metal ions in the blood, which could pose a danger. The FDA wants more information about this scenario as well.
As a San Francisco personal injury lawyer, it grieves me to see an entire product line possibly do harm to the very people it was meant to help. I hope the FDA makes the right decision in their June meeting, but whatever their choice, the impact will most certainly affect many people, including a Long Beach personal injury lawyer like me.