Some surgical implants, like cardiac stents and pacemakers, are clearly lifesaving. And artificial joints can vastly improve mobility and enhance the quality of life of patients with severely damaged joints. However, serious concerns about the safety and efficacy of artificial hip and knee devices and other widely used surgical implants have surfaced in recent years. Some of these popular devices have even proven to be life-threatening, yet they continue to be aggressively marketed by their manufacturers, with little oversight by federal regulators. Unlike pharmaceutical drugs, these medical devices do not have to be tested in clinical trials prior to widespread distribution. And while they are meant to undergo a premarket approval process in which the device manufacturer is required to provide “reasonable assurance” of their safety and efficacy, many manufacturers are able to skip this step by claiming that their implant is “substantially equivalent” to one that already exists on the market.
For instance, hip and knee implants are commonplace in the United States today. In 2014, 522,800 hips and 723,100 knees were replaced, along with 90,000 shoulders, 16,000 finger joints, 15,000 elbows, 2,000 ankles and 2,000 wrists, for a total of nearly 1.4 million joint replacement procedures. And by 2030, an estimated four million joint replacement procedures will be performed each year. But just because these procedures are common, doesn’t necessarily mean they are safe. In fact, medical interventions have emerged as one of the leading causes of death in the United States, and still, the majority of high-risk implanted medical devices are never tested in clinical trials before going to market.
These devices include not only hip replacements, but surgical mesh implants, cardiac stents and IVC filters, among others. The unfortunate truth is that even surgical implants that have been shown to be safe and effective may pose serious risks for patients. For instance, based on the FDA’s own analysis of scientific literature and adverse event reports submitted by patients, implantable mesh devices approved by the FDA and widely used for the surgical repair of hernias have been linked to an increased risk of debilitating complications like mesh erosion, infection, pain, hernia recurrence and perforation of neighboring tissues or organs.
The recalled DePuy ASR hip replacement system is a prime example of the serious health risks that have been linked to medical devices approved for the U.S. market and implanted in patients by the thousands. Between 2003 and 2010, more than 90,000 patients worldwide were implanted with DePuy’s Articular Surface Replacement (ASR) hip device, which was designed to improve stability and increase range of motion in the hip joint. In 2010, the hip implant was recalled after it was discovered that the metal-on-metal device could shed microscopic metal particles into the body, triggering severe inflammation around the implant and exposing implant recipients to an increased risk of complications ranging from pain and swelling to nerve and bone damage, fractures, implant loosening, infection and metal blood poisoning. DePuy ultimately reported that one in eight ASR hips failed within eight years and the company ended up facing thousands of product liability lawsuits filed by patients who required revision surgery to remove or replace their failed ASR hip implants.
DePuy’s failed ASR hip is hardly an isolated example of the dangers of popular surgical implants. At the end of 2018, Bayer withdrew its Essure permanent birth control implant from the market after thousands of women reported suffering problems like excruciating pain, device migration, allergic reaction and perforation of the fallopian tubes or uterus. In 2010, the FDA issued a safety communication reporting that the agency had received 921 reports of adverse events involving inferior vena cava (IVC) filters between 2005 and 2010. IVC filters are small filters implanted in the inferior vena cava to prevent blood clots from traveling to the heart and lungs and causing pulmonary embolism. For more than a decade, the filters have been linked to serious, potentially life-threatening complications like filter migration, filter fracture, embolization, injury to nearby organs and perforation of the inferior vena cava. In one study published in the American Journal of Medicine in 2012, researchers found that only a small percentage of patients at risk for pulmonary embolism actually benefitted from IVC filter implants, while the rest were exposed to these potential side effects without any health benefit.
When patients consent to being implanted with a medical device, they have the right to believe with a certain degree of confidence that the device has been shown to be safe and beneficial, meaning it has the potential to help, rather than harm. Unfortunately, writes orthopedic surgeon and author of The Invention of Surgery David Schneider, “even under the best of circumstances, patients are, in effect, part of a large, uncontrolled experiment, and when the regulatory framework in a society is flimsy, sluggish, or nonexistent, is it any wonder that patients can be harmed by the thousands?” If you or someone you loved has suffered serious side effects allegedly caused by a defective medical device, don’t hesitate to pursue the financial compensation you deserve. Contact an experienced product liability lawyer to discuss the possibility of filing a personal injury or wrongful death lawsuit against the medical device manufacturing company.