Defective Metal on Metal Hip Implant of Biomet
Over the past 10 years, an increasing number of complaints were reported pertaining to failed hip replacement surgeries due to a defectively designed implant, an online source says. A recent data from a review conducted by the United States Food and Drug Administration suggests that metal-on-metal hip replacement devices were associated with some 16,800 adverse event reports from years 2000 t0 2011 and 14,000 involved revision surgeries, says an online report from the newson6.com website.
Metal on metal hip replacement devices are used to be a popular choice of some hip surgeons and doctors but the growing number of complaints received from patients prompt some manufacturers to recall some of their hip implants, specifically metal designed devices. Biomet is one of the many medical device manufacturers which have contributed a number of new technologies into the orthopedic device industry. Among Biomet’s line of products, hip replacement devices are still the foundation of the company.Metal on metal designs such as M2a Magnum hip implant products including Stanmore and Exceed ABT devices has been causing problems despite of Biomet’s booming business.
Just like hip replacement systems made from other medical device manufacturers, Biomet’s metal-on-metal products can cause variety of complications, including metallosis. Metallosis is a result of metal poisoning caused by metal particles that were mixed in the body’s bloodstream due to two metal components that are constantly rubbing each other.
It has been said that Biomet’s hip replacement devices have been the subject of growing safety concerns since the August 2010 recall of DePuy Orthopaedics’ ASR hip resurfacing system and ASR Acetabular system. Apparently, these problems has been the agenda of the two days meeting between the agency (FDA) and the Orthopaedic and Rehabilitation devices panel, specifically to examine the safety of the metal-on-metal hip implants concerning the potentiality of these devices to expose patients to dangerous levels of metallic debris.
To date, there are reported hundreds of lawsuits that were filed against Biomet, alleging that the company has early knowledge of the defects of its design which is a claim very common to all device manufacturers which had a recall of their products for the past five years. It was reported that a medical expert once said that the answer to the problem is not recall but just a temporary obstruction to further damages; thus clinical studies should have been a mandatory requirement that needs to be performed before a device was released and not a solution of a problem that might have been prevented to exist.