Pharmaceutical

FDA: Metal-on-Metal Hip Implant Patients Risk Soft Tissue Damage

17HIP2 articleInline FDA: Metal on Metal Hip Implant Patients Risk Soft Tissue DamageMetal-on-metal hip implants have been in the spotlight lately for the lawsuits associated with patients claiming to be injured by their faulty design. The litigation prompted the U.S. Food and Drug Administration (FDA)  to call for manufacturers of these devices to conduct studies examining safety and efficacy, and has added warnings of its own the the medical devices.

Companies such as Johnson & Johnson and its subsidiary DePuy Orthopeadics; Smith & Nephew; and Wright Medical manufacture metal-on-metal hip implant designs that have been shown to fail at an alarmingly high rate.

In an article published by Medical News Today, the FDA states that there aren’t very many reasons left for which a patient should ever choose to use a metal-on-metal hip implant.

Traditional hip implants are made of plastic or ceramic parts that can last up to 20 years. Initially, the metal-on-metal designs were recommended for patients that were younger or had higher levels of activity in their daily lives, and the surgeons claimed that they would last longer and perform better for more active lifestyles.

But it wasn’t long before patients implanted with the all-metal devices began complaining of pain, numbness, swelling, clicking or popping, and difficulty walking. When any of these symptoms persist, it often results in revision surgeries, which are usually more painful than the original joint replacement surgery.

Reports indicate metal-on-metal designs are failing in as little as five years, and many patients are experiencing adverse affects such as loosening, which is an especially dangerous issue for this design. As the parts of the device rub together during normal activities such as walking or running, the metal parts grind together, which may result in metal debris shedding into the body.

When the design has a tendency to loosen, the parts rub together even more, exacerbating the problem. This release of metal can harm the soft tissue around the implant, potentially causing bone damage and possibly a type of blood poisoning called metallosis.

Source: Medical News Today