Jeanne Lenzer writes for the New York Times about the danger of getting a hip replacement. In some cases, your hip replacement could cause serious harm. In general, as we have reported, FDA-approved medical devices may not be safe.
Stephen Tower, an orthopedic surgeon, had a metal-on-metal hip implanted, the ASR XL, made by Johnson & Johnson. Dr. Tower specializes in complex hip replacements, but he was not aware that the hip he chose for himself had a serious defect. He ended up needing another surgery because of the pain his artificial hip was causing him.
Dr. Tower’s artificial hip had turned the tissue around it black. The artificial hip leaked cobalt causing Dr. Tower to suffer from metallosis. Muscles, tendons and ligaments near the hip were destroyed. Worse still, Dr. Tower suffered damage to his heart and brain.
Afterwards, Dr. Tower warned Johnson & Johnson of the serious defect in the hip but the medical device company did nothing about it. Rather, it continued to market metal-on-metal hips. It finally withdrew the ASR XL model from the market in 2010, but it sold another metal-on-metal hip, the Pinnacle, until 2013.
Thousands of people received a Johnson & Johnson metal-on-metal hip replacement during this time. Six of them won a $247 million verdict because of the Pinnacle’s harmful side effects and because Johnson & Johnson did not warn doctors or patients about these side effects.
Unfortunately, these metal-on-metal hips are one of many FDA-approved medical devices on the market that put patients at risk for dangerous side effects. A provision of the Federal Food, Drug and Cosmetic Act, known as 510(k), allows medical device companies to market many new products without having to do any clinical trials. All that the medical device company need do is claim that the device is “substantially equivalent” to a medical device already on the market.
While the FDA can recall the product if it is deemed to cause harm, it can take a long time for that recall to happen. Hundreds of thousands of people can end with the device implanted before it is recalled. And removal of the device once recalled can also jeopardize patients’ health.
In 2016 alone, the FDA recalled 117 medical devices because of a “reasonable probability” that they would “cause serious adverse health consequences or death.”
Medical devices that undergo clinical trials are also not guaranteed to be risk free. Indeed, the FDA may conditionally approve them even when the clinical trials show potentially harmful side effects, including a high death rate. That’s what happened with a Cyberonics device designed to treat epilepsy. The FDA did not require that patients who received this device be told about the risk of dangerous side effects.
The FDA’s approval process appears to put profits before patients. Yes, more devices get to market more quickly. But, at what cost to human life and health?
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