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Device Fast-Tracking is Legal, But Leaves Many Recipients Injured

Jan 14, 2013

Complication reports, mounting litigation, and concerns over a lack of clinical testing have raised questions about the safety of some medical devices that have been approved through a regulatory fast-track process known as the 510(k). In 510(k) fast-tracking, a formal review for safety and efficacy is neither required nor performed. The 510(k) route has been used to gain clearance for an array of controversial products, such as metal-on-metal hip implants and, now, the process is drawing increasing criticism.

In a recent article, The New England Journal of Medicine points out that many medical devices pose significant safety risks, including metal-on-metal hip implants. The New England Journal of Medicine notes that these devices enter the U.S. market via the U.S. Food and Drug Administration (FDA) in a way that is not meant for evaluating safety and efficacy. Rather, the 510(k) process, evaluates the emerging device’s “substantial equivalence” to previously cleared devices. Many of these previously cleared devices, The New England Journal of Medicine notes, have never undergone safety and efficacy testing. In fact, some are no longer in use due to poor clinical outcomes.

When metal-on-metal hip implants were first brought to market some 10 years ago, it was with the belief that the newer devices would be superior to older devices that were manufactured using plastic or ceramic.

Concerns about metal-on-metal—sometimes referred to as all-metal—hip implant devices peaked in 2010 when DePuy Orthopaedics issued a worldwide recall of its ASR hip implant devices. The ASR devices were failing in about 12 percent of patients within just five years of implantation, an unanticipated and significant increase over established failure rates associated with hip replacement systems. DePuy Orthopaedics is a unit of Johnson & Johnson.

Since, a number of studies have pointed to significant problems with metal-on-metal hip implants. If fact, last year, the FDA revealed it had received 16,800 negative event reports involving metal hips between 2000 and 2011. Of those reports, more than 14,000 involved revision surgeries, in which a defective implant was removed; a surgical process that involves more surgical and recover time and greater risks than the original surgery.

Studies have revealed that the issue with metal-on-metal hip implant devices is that they shed tiny chromium and cobalt particles into patients’ bodies when the devices’ metal surfaces rub against one another, typically with the full weight of the body involved. The unexpected process has been associated with a broad and growing series of adverse physical effects such as tissue necrosis, pain at the implant site that can spread to the groin and back, inflammation, swelling, metal poisoning, high failure rates, osteolysis (bone loss), and fluid collection/solid masses around the hip joint.

A recent study has linked the devices to the formation of cysts and severe limb swelling, new adverse reactions to the already controversial devices. As with established adverse reactions, the formation of cysts and severe limb swelling are typically resolved with revision surgery to remove the defective device and re-implant the patient with another, different medical device.

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