Minimal Medical Device Regulations Pose Serious Dangers to Metal Hip Implant Patients

Medical devices such as pacemakers, cardiac stents, surgical mesh, defibrillators, heart valves, artificial joints, and nerve stimulators are given to patients commonly in the United States. In fact, approximately 32 million Americans have one or more medical devices implanted in their bodies. Although, many of these devices provide health saving benefits, too many of them have also inflicted terrible injury or premature death.

In 2015 alone, the FDA received 16,000 reports of fatalities connected with the use of medical devices.

A JAMA Internal Medicine study revealed that each year the Federal Drug Administration (FDA) gives the go-ahead for 400 implanted medical devices associated with moderate to high risk with zero clinical testing performed in advance.

Case of hip implant failure

A recent case reported in The New York Times exposes the severe dangers posed by certain types of medical implants. The case involved a metal-on-metal hip implant that nearly took the life of Orthopedic Surgeon Dr. Stephen Tower. Due to the failure of his own hip in 2006, he obtained a metal on metal ASR XL implant made by Johnson & Johnson. Dr. Tower had implanted these types of Johnson and Johnson metal on metal hip replacements to some of his own patients over time – so he had familiarity with the device. However, what followed for Dr. Tower in the years after his hip replacement surgery was painful and destructive.

Detailing the devastation Dr. Tower experienced, The New York Times reported:

“Five years after his surgery, and in excruciating pain, Dr. Tower underwent more surgery, this time to have the device replaced. When the surgeon sliced into his hip, what he saw looked like a crankcase full of dirty oil. Tissue surrounding the hip was black. Cobalt leaking from the ASR hip had caused a condition called metallosis, destroying not only local muscle, tendons and ligaments, but harming Dr. Tower’s heart and brain as well.”

Dangerous side effects from faulty metal hip implant devices

Dr. Stephen Tower is not alone. Other patients who presently have metal on metal hip replacement devices are at risk of experiencing health debilitating side effects. Other than death, the dangerous quantities of cobalt and chromium that can enter the patient’s bloodstream from one of these defective devices can inflict a multitude of other consequences. These include: vision problems, hearing loss, continual pain, tinnitus, anxiety, mood swings, and disturbed sleep patterns. The problem involves metal debris from the prosthetic wearing off and making its way through the body as a poisoning agent.

According to medical investigative reporter Jeanne Lenzer, the writer of The New York Times article, of the many very high-risk medical devices with the potential to cause serious injury or death to patients, only 5 percent were subjected to even two clinical trials. The standard for testing in many cases seems nonexistent. Up until 1976, the FDA, through a provision known as 510 (k), grandfathered in medical devices that were presently on the market. This enabled manufacturers to sell the majority of new devices without subjecting them to clinical testing. The only requirement was that the manufacturer state its product was “substantially equivalent” to a device already on the market.

If you or a loved one has suffered an injury due to a defective medical device, our attorneys at McGowan, Hood, Felder & Phillips, LLC can help you obtain the justice and compensation you deserve. We handle the most complex cases and are committed to delivering results on your behalf. To set up a free consultation with a defective medical device attorney from our team, complete our contact form or simply call us today at 803-327-7800.