• Regulatory NewsRegulatory News

    MHRA Updates Alert on Metal-on-Metal Hip Implants

    The UK's Medicines and Healthcare products Regulatory Agency (MHRA) on Thursday issued an alert to healthcare professionals with updated recommendations for long-term follow-up for patients with metal-on-metal hip replacements. Safety and durability concerns about metal-on-metal hip replacements, along with a scandal involving faulty breast implants, were a driving factor in the EU's decision to overhaul its medical device and in vitro diagnostics regulations. Previou...
  • Regulatory NewsRegulatory News

    FDA to Require PMAs for Two Types of Hip Replacement Devices

    The US Food and Drug Administration (FDA) on Wednesday announced the issuance of a  final order  requiring manufacturers to submit a premarket approval (PMA) application for two types of metal on metal (MoM) total hip replacement devices. The new PMA requirement for the two types of devices -- the hip joint metal/metal semi-constrained with a cemented acetabular component and the hip joint metal/metal semi-constrained with an uncemented acetabular component -- comes as F...
  • Regulatory NewsRegulatory News

    European Commission Issues Final Opinion on Metal-on-Metal Hip Implants

    This content is provided by RegLink News , publishers of e-weekly global regulatory news. RegLink offers a 30-day free trial and 15% discount on Global Update subscriptions to RAPS members. The European Commission’s Scientific Committee on Emerging Newly Identified Health Risks (SCENIHR) issued on 9 October 2014 its final opinion regarding the safety of Metal-on-Metal (MoM) joint replacements, and hip implants in particular. SCENIHR's report concludes th...
  • European Commission Report Calls for Restricted Use of Metal-on-Metal Hip Implants

    The European Commission's Scientific Committee on Emerging Newly Identified Health Risks (SCENIHR) -a scientific committee which conducts risk assessments for EU officials-has announced the publication of its initial draft assessment of the safety of metal-on-metal hip implants. Background Metal-on-metal hip implants have been plagued with controversy around the globe. The devices, which claimed to be similar enough to predicate devices made with non-metal parts, have...
  • New FDA Study to Look at Causes of Failure in Hip Implants

    One of the largest medical device scandals in the last decade has involved metal-on-metal hip implants, so-named because of the metal (usually chromium) attachment that attaches a leg to a metal socket. In the wake of their failures, the US Food and Drug Administration (FDA) moved to examine its regulatory processes, eventually deciding to require premarket approval (PMA) applications for all such implants. But now evidence has emerged that the agency still has further q...
  • Bloomberg: After Failing Testing, J&J Altered Approval Criteria for Now-Recalled Hip Implants

    • 29 January 2013
    At the beginning of 2012, The New York Times made something of a sensational claim: Johnson & Johnson had worked to privately phase out its now-controversial metal-on-metal hip implants in 2009 after US regulators approached the company with concerns about their durability and patient safety. In response to that report, the company indicated that the two events were "unrelated," but now new and potentially troubling information is emerging from a Los Angeles cou...
  • PMA Application to be Required for Controversial Hip Devices, Says FDA

    The US Food and Drug Administration (FDA) has proposed a new rule that would classify all hip joint metal-on-metal semi-constrained prosthesis with either cemented or un-cemented acetabular components as class III medical devices requiring the submission of a premarket approval application (PMA) or a product development protocol (PDP) instead of a 510(k) premarket notification. The devices have been plagued with controversy around the globe. The devices, which claimed ...
  • Regulatory 'Loophole' Allowing Unsafe Devices to be Marketed, Say Researchers

    • 10 January 2013
    A "loophole" in the way in which some medical devices are regulated is allowing unsafe devices to reach-and harm-patients, argues a new editorial published in the New England Journal of Medicine . The loophole stems from the 1976 Medical Device Amendments , which established for the first time in the US a system for the regulation of medical devices.  The system classified medical devices into three general categories: Class I for low-risk devices, class II for ...
  • 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...
  • Industry Pans EU Plan to Implement Medical Device Registry

    One of the medical device industry's biggest organizations is sounding off against a plan by the European Parliament to implement postmarketing medical device implant registry system that aims to protect consumers against the types of problems currently plaguing the European market. As Regulatory Focus reported on 27 April, the European Parliament released the plans after two prominent medical device failures -metal-on-metal hip implants manufacturer by, among other...
  • 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...