FDA implant testing process fails women
TX – According to the newscentermaine.com, the Food and Drug Administration (FDA) does not put medical devices through the same level of scrutiny and rigorous testing as it applies to drugs. This can be problematic for the 7 million people who undergo surgical procedures in order to implant some form of a medical device into their bodies.
The complications the lack of adequate testing create for patients is highlighted in the case of Francis Scott, a woman who was formerly a news anchor and active mother of three. Scott suffered from severe hip pain in her early 30s. Her doctors told her she appeared to have been born without sockets, and that when she started walking, her sockets formed in the wrong location. Her doctors told her that the best option was to undergo double hip replacement surgery.
Scott was just 39 when she underwent the procedure. She was told that while it was a major operation, she would be on her feet again in a matter of months.
According to Skip Phillips, Scott’s husband, the process was not normal. Following the implantation of two metal-on-metal replacement hips, Scott suffered oozing boils on her face, memory loss and tinnitus. She never stopped feeling the pain. Her hands began shaking as well. While she tried to discover what was wrong, her doctors told her no one was having trouble with the implants and that her x-rays indicated that hers were working fine. She finally came across research conducted in England that indicated that other patients who had the same implants were suffering similar symptoms as a result of metal poisoning.
To many people’s surprise, the FDA never tested the metal-on-metal designs in people, only in simulators. The simulators were not adequate to show the impact of metal debris entering a person’s body. There are now more than 10,000 lawsuits against Johnson & Johnson for their DePuy metal-on-metal hip replacements.
