• 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...
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    MHRA Calls for Continued Quarantine of Silimed Implants

    The UK’s Medicines & Healthcare products Regulatory Agency (MHRA) on Friday reiterated its call to quarantine implants manufactured by Brazil’s Silimed, saying it’s still trying to determine if there are potential health risks associated with particles found on the surface of the devices. The caution from MHRA comes a day after Jeffrey Nugent, Sientra chairman and CEO, a US-based supplier of Silimed products, sent a letter to plastic surgeons informing them that an indep...
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    FDA Calls for 'Cautionary Approach' on Brazilian Manufacturer's Suspended Implants

    The US Food and Drug Administration (FDA) told RAPS' Regulatory Focus that it concurs with breast implant provider Sientra's caution in voluntarily placing a temporary hold on the US sales of all devices from Brazilian implant manufacturer Silimed. "We concur with Sientra’s recommendations to take a cautionary approach until more is known, and we are actively working with the company and other international regulators to investigate the issue. The FDA is in close c...
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    Fallout Continues from MHRA Suspension of Brazilian Manufacturer's Implants

    Two days since the UK's Medicines and Healthcare products Regulatory Agency (MHRA) halted all sales of Silimed's silicone implants, and at least two other regulators have followed suit, while Silimed insists its devices are safe and has criticized MHRA's criteria for particle levels. Background MHRA on Wednesday suspended the CE certificates of the Brazilian device manufacturer Silimed, which claims to be the largest manufacturer of silicone implants and the largest b...
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    MHRA Suspends All Devices from Largest South American Silicone Implant Manufacturer

    The UK's Medicines and Healthcare products Regulatory Agency (MHRA), alongside EU member state regulators, announced Wednesday the suspension of all CE certificates for medical devices made by Brazilian manufacturer Silimed. The suspension comes as a German notified body recently inspected one of the Brazilian manufacturing sites of Silimed, which claims to be the largest manufacturer of silicone implants and the largest breast implant manufacturer in South America, and ...
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    Are Notified Bodies Responsible for the Failure of Companies They Oversee?

    A legal battle in Germany to determine responsibility in the aftermath of the Poly Implant Prothese (PIP) breast implant scandal will be put on hold while a German court asks for clarification from the European Court of Justice (ECJ), Deutsche Welle reports. Background For many years, PIP was one of the largest producers of silicone breast implants. However, after it came to light that the company used industrial-grade silicone in its implants, the company shut ...
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    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...
  • 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 ...
  • French Executive Released from Prison to Await Trial over Regulatory Fraud

    • 30 October 2012
    The former executive of a French medical device company accused of manufacturing and selling breast implant products manufactured with sub-standard industrial-grade silicone has been released from jail to await charges of causing involuntary bodily harm and aggravated fraud, reports Reuters . Jean-Claude Mas, the former head of the now-defunct implant manufacturer Poly Implant Prothese (PIP), was among several executives arrested earlier in the year after regulato...
  • European Commission Proposes Major Overhaul of EU Device Legislation

    • 27 September 2012
    The European Commission has just released two highly anticipated proposed regulations set to revamp the medical device regulatory framework in the EU-one for  general medical devices , including active implantables, and another for  in vitro devices -imposing tougher rules for assessing the safety and monitoring the use of medical devices and implants. The proposed regulations come after weak EU medical device regulations were partly blamed for a global scandal...
  • MHRA Officials Find Suspect Breast Implant Product Rupturing at Accelerated Rate

    Regulatory officials at the UK's Medicines and Healthcare products Regulatory Agency (MHRA) have released an interim report looking into an implantable medical device that was recently found to be manufactured using sub-standard and unapproved components . MHRA regulators have since 2010 been focused on breast implant products manufactured by now-defunct French manufacturer Poly Implant Prothese (PIP), whose products were manufactured with industrial-grade, rather tha...