• UK Convenes Expert Panel to Assess New Regulatory Framework for Implants

    • 15 August 2012
    The UK's Department of Health (DOH) is preparing to launch an expert inquiry into ways to protect consumers from potentially dangerous cosmetic implants, just months after UK regulators concluded there was significant room for improvement. In a 15 August press release , DOH said a panel of experts led by Sir Bruce Keogh, the National Health Service's medical director, would examine the regulatory framework for cosmetic products in the UK, the information available to pa...
  • FDA Meeting on Hip Implants Recommends Against Use

    A panel of experts convened on Thursday, 28 June by US regulators has recommended against the use of metal-on-metal hip implants in patients, reports the Associated Press. The hips, cleared for use by the US Food and Drug Administration (FDA) through its 510(k) pathway which assesses products for "substantial equivalence" to existing products, have been increasingly under fire in recent months as safety concerns mount. UK regulators recently advised surgeons to stop im...
  • MHRA, Researchers Warn of Metal-on-metal Hip Implant Risks

    In separate announcements, the Medicines and Healthcare products Regulatory Agency (MHRA) and a group of researchers have both raised troubling new questions about the failure rates of metal-on-metal (MoM) hip implants and how regulatory authorities can best respond. In a statement released 25 June, MHRA said it was advising surgeons to refrain from using a metal-on-metal hip implant product manufactured by Smith & Nephew after being made aware of postmarketing surve...
  • China Signs MOU with the Netherlands

    • 07 May 2012
    China's State Food and Drug Administration has further expanded its international collaborative efforts in regulatory matters by concluding a Memorandum of Understanding (MOU) with the Ministry of Health of the Netherlands. The new MOU calls for expanded cooperation between the two countries on matters relating to the regulation of drugs and medical devices. A Dutch company had exported to China breast implants containing industrial grade silicone that were supplied by...
  • MHRA issues new metal-on-metal hip replacement advisory

    The UK Medicines and Healthcare products Regulatory Agency (MHRA) has advised surgeons to stop using a particular combination of metal-on-metal total hip replacements because of a high revision rate compared with other implants. The advice is included in a new MHRA Medical Device Alert targeting the Mitch TRH cup/heads, made by Finsbury Orthopaedics, used in combination with Accolade femoral stems made by Stryker Orthopaedics. Information from the England and Wales Nati...
  • MHRA Advises Surgeons Against Using Some Metal-on-Metal Hip Implants

    The Medicines and Healthcare Products Regulatory Agency (MHRA) today (2 April) announced it is recommending surgeons "stop using a particular combination of metal-on-metal total hip replacements because it has a high revision rate compared with other implants." The implant combination-Mitch TRH cup/heads, made by Finsbury Orthopaedics, used in combination with Accolade femoral stems made by Stryker Orthopaedics-is associated with an "unacceptably high revision rate of 10...
  • FDA Plans Meeting on Metal-on-Metal Hip Implants

    The US Food and Drug Administration (FDA) announced it is looking to hold a two-day meeting on implantable metal-on-metal (MoM) hip implants, saying it wants public input on whether to make the devices subject to more rigorous testing. "Numerous recent publications, studies and registry reports have raised safety concerns for MoM total hip replacements," said FDA in the Federal Register posting, including reports from the UK's Medicines and Healthcare products Regulato...
  • Poll: Public In Favor of Increased Medical Device Regulation

    A poll commissioned by industry watchdog group Consumer Reports indicates the vast majority of consumers are in favor of a risk-averse regulatory framework for medical devices , giving ammunition to the group at a time when it is seeking to influence the debate over the reauthorization of the Medical Device User Fee Act . Consumers Union has taken the position that medical devices-particularly those cleared through the US Food and Drug Administration's (FDA) 510(k) pat...
  • Researchers: Metal-on-Metal Hips Implants Should be Banned

    Researchers working with the world's largest database on hip replacements have found so-called metal-on-metal hip implants are associated with high rates of failure, and recommended that they not be implanted in patients going forward. Writing for the journal The Lancet , the researchers found that more than half a million US patients and 40,000 UK patients are implanted with the devices and subject to a higher risk of device failure than those patients with non-metal h...
  • BMJ: Patients in US, UK Unknowingly Exposed to Toxic Substances

    The fallout over metal-on-metal hips distributed in the US and UK continues as a new article in the British Medical Journal alleges that hundreds of thousands of patients have been exposed to toxic substances as a result of being implanted with the devices. "Despite the fact that these risks have been known and well documented for decades, patients have been kept in the dark about their participation in what has effectively been a large uncontrolled experiment," write...
  • MHRA: Patients With Metal-on-Metal Hips Need Extensive Monitoring

    The Medicines and Healthcare products Regulatory Agency (MHRA) issued advice to patients and surgeons urging them to monitor so-called metal-on-metal hip replacements on an annual basis for the lifetime of the device. Previous advice by MHRA has only advised patients and surgeons to monitor the device for 5 years after the device was implanted. "This updated advice is based on updated evidence that patients with hip replacements with head diameter of 36 millimetres or...
  • New Safety Concerns About Metal-on-Metal Hip Implants Prompt MHRA Investigation

    The UK Medicines and Healthcare products Regulatory Agency (MHRA) is announcing that it is launching a safety investigation in light of concerns that patients fitted with metal-on-metal hip implants are at risk for a variety of adverse reactions. An investigation by The Telegraph found that MHRA is "drawing up new advice for more than 30,000 Britons who have received 'metal-on-metal' devices because of fears that they are even more dangerous than previous...