If you are one of the many Montana residents who underwent a hip replacement because one of your real hips “gave out,” you may be at risk for complications that could cause you extreme pain or even death. A recent New York Times article reported on an orthopedic surgeon who asked for an artificial hip in 2006. By 2011, after suffering excruciating pain, he requested additional surgery to replace it.
His surgeon was horrified to discover that the patient’s hip “looked like a crankcase full of dirty oil.” Metallosis, a medical condition in which metal debris builds up in a patient’s soft tissues, had set in. Cobalt leakage from the ASR XL, a metal-on-metal hip made by Johnson & Johnson, destroyed the patient’s hip muscles, ligaments and tendons, harming his brain and heart as well.
The company withdrew its ASR XL model in 2010, but continued to sell the Pinnacle, a similar artificial hip, until 2013. Over 9,000 consumers sued Johnson & Johnson over these hips, and six of them in New York recently won a $247 million verdict.
Dangerous medical devices
You should be aware that metal hips are not the only medical devices that can and do fail, causing patients catastrophic consequences, up to and including death. Others include the following:
- Sprint Fidelis defibrillator
- Vagus nerve stimulator
- Cardiac stents
- Heart valves
- Surgical mesh
In 2016 alone, 117 Class 1 medical devices were recalled. Many doctors call the medical device industry the “Wild West of medicine,” leaving the 32 million Americans – about 10 percent of the population – with implants to worry that theirs will be the next one to fail.
Lax FDA oversight
Despite the fact that the Federal Drug Administration regulates medical devices, it does not do so to the extent that it regulates new drugs. In fact, when the FDA started regulating medical devices in 1976, it grandfathered in devices already on the market. Worse yet, provision 510(k) of the FDA regulations allows manufactures to sell any new product “substantially equivalent” to one already in existence without clinically testing it.
The “supplemental pathway” is another loophole whereby manufacturers can bring a new product to market without clinical testing. All they must do is tell the FDA that the new product is merely a “minor change” to an already approved device. All of this leaves you and your doctor at the mercy of manufacturers who naturally claim that their medical devices are safe, but have no test data to back up their claims. This is general information only and is not intended to provide legal advice.