subject: The Metal-on-metal Hip Replacement And Complications [print this page] The United States Food and Drug Administration is seeking a product recall against the controversial metal-on-metal hip implants after evidence shows its high-failure rates, medical experts say, pointing out that stopping their distribution in the market is in step with public safety regulations. Hip implantation is a procedure done among patients suffering from excruciating pain caused by a chronic disease such as osteoarthritis.The increasing number of hip recall lawsuits has alarmed the FDA. Legal experts believed that in the light of the statute of limitations, it may bar plaintiffs'cases.
Osteoarthritis also includes progressive loss of cartilage. The cartilage tries to cure by itself, the bone remodels, the underlying (subchondral) bone hardens, and bone cyst forms, the emedicinehealth.com website says.
Data show that are about 400,000 hip replacements found on metal-on-metal implants needed revising more often than other types and that the failure rates were higher in women.
It comes two weeks after the Medicines and Healthcare Products Regulatory Agency (MHRA) issued new direction on the implants, saying almost 50,000 patients in the UK will need yearly blood or MRI checks.
Tiny metal ions made up of cobalt and chromium are thought to break off from the implants and may seep into the blood, causing muscle and bone damage as well as neurological issues.
The MHRA says there is a little danger, though, with the implants which may cause complications in patients.
The research being published in the Lancet medical journal, quoting data from the National Joint Registry of England and Wales, discovered that the metal-on-metal implants failed much more quickly than other types of implant, with a five-year revision rate of 6.2%.
Hip replacements are common among patients with osteoarthritis, where there is large wear and tear on the hip joint. The examination encompasses more than 31,000 metal-on-metal implants. It looked at patients given implants between 2003 and 2011 and tracked them up to seven years after surgery.
About 65,000 people in the UK have received metal-on-metal hip implants since 2003, of which 49,000 are affected by the MHRA guidance because the joint head is 36mm or greater.
Usually one of the problem of metal-on-metal hip implants is metallosis, which is also known as metal poisoning. This usually happens when metallic debris accumulates in the bodys soft tissue.
The metal parts from orthopedic devices may shed small metal particles when they grind together. When the metallosis occurs, the immune system identifies the metal ions as foreign bodies and aggressively attacks the soft tissue that contains them. Damaged and inflammed tissue may contribute to premature loosening of the orthopedic device. Metallosis may also lead to necrosis, which is characterized by extreme skin rash and death of skin cells, the drugsideeffects-info.com website says.
Meanwhile, in women, failure rates for metal-on-metal artificial hips were up to four times higher than for other types, making them at risk of becoming one of the subject of the DePuy hip recall.
