• 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...
  • Australia Releases New Joint Replacement Reclassification Guidance

    Australia's Therapeutic Goods Administration (TGA) has posted new guidance reclassifying joint replacements such as hip, knee and shoulder replacement devices. Under the new guidance, applications to reclassify a joint replacement implant from Class IIb (medium-high risk medical devices) to Class III (high-risk medical devices) could require more than one application. A single Class IIb joint implant may have to be 'cloned' into multiple reclassification applications i...
  • 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...
  • 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...