• European Commission Committee Clears PIP Breast Implants of Major Health Concerns

    The European Commission has released the text of a long-awaited follow-up opinion regarding the safety of breast implants manufactured by the now-defunct Poly Implant Prothese (PIP), a French manufacturer whose products ignited a firestorm of controversy over the safety of medical devices in the EU after they were found to have been manufactured to deficient standards. Background The PIP scandal erupted in late 2011, when regulators determined that the company had bee...
  • NICE Guidance Recommends New Test for Breast Cancer Metastasis

    The UK's National Institute for Health and Care Excellence (NICE) has issued guidance recommending a new test for surgeons to use to determine whether breast cancer has spread. The test, the RD-100i OSNA system produced by Sysmex UK, can detect if the cancer has spread to lymph nodes in the armpit during the surgery to remove the tumor. This is a significant advance over the current practice, in which the sentinel lymph nodes are removed during the initial tumor remov...
  • UK’s MHRA Proposes Tracking System for High Risk Devices

    The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has announced that four National Health Service hospitals have agreed to pilot a new tracking system for high risk medical devices.  The goal of the tracking system, one of 11 projects established by the agency in response to the Poly Implant Prothèse silicone breast implant issue, is to improve the monitoring of medical devices such as breast implants, heart valves and pacemakers. The new...
  • UK Disagrees with Sweden on PIP Breast Implant Removal

    A new report by Sweden's Medical Products Agency and the National Board of Health and Welfare recommends that breast implants manufactured by now-defunct French manufacturer Poly Implant Prothèse (PIP) should be removed from patients for preventative reasons, except in individual cases where there are medical reasons for not doing so.  However, the UK's Medicines and Healthcare products Regulatory Agency (MHRA) issued a public statement reiterating its p...
  • Pfizer Claims Fourth Breakthrough Product Designation, But Joins Others in Citing Unclear Benefit

    Pharmaceutical manufacturing giant Pfizer has announced that its breast cancer candidate palbociclib has received a new and coveted breakthrough product designation from the US Food and Drug Administration (FDA), the third company and fourth product to announce their receipt of the designation to date. Background Though many companies are seeking breakthrough product designation-40 requests in all through 31 March 2013, by FDA's count --It's not entirely clear what the...
  • NICE Green Lights IVD for Breast Cancer Diagnosis

    The UK's cost containment agency, the National Institute of Health and Clinical Excellence (NICE), has agreed to recommend the use of an innovative new diagnostic test designed to guide the use of chemotherapy in patients with early breast cancer. Specifically, the recommendation covers the use of Oncotype DX in patients in the early stages of oestrogen receptor positive (ER+), lymph node negative (LN-) and human epidermal growth factor receptor 2 negative (HER2-) breast...
  • US Regulators Approve Fourth Breast Implant Product, Call for Extensive Safety Testing

    If there's one device that global medical device regulators have spent much of the last year worrying about, it's breast implants. But now, and with a nod to safety critics, US regulators have approved a fourth breast implant product for marketing in the US. Background Late in 2011, French regulators began to receive reports that breast implants manufactured by Poly Implant Prothese (PIP) were failing at an alarmingly high rate. The ensuing fallout was in many ways th...
  • Report: FDA Oversight of State Mammography Accrediting Bodies Adequate

    • 18 January 2013
    A report completed by the US Food and Drug Administration (FDA) in 2012 and just released on 16 January 2013 provides an evaluation of one of the agency's lesser known responsibilities: overseeing quality standards for mammography facilities. That responsibility was given to it in 1992 under the Mammography Quality Standards Act (MQSA) . Amended in 1998 and 2004, the act is intended to make sure that facilities are accredited by approved certifying agencies and or...
  • NICE Draft Guidance Recommends Drugs Not Indicated for Familial Breast Cancer

    The National Institute of Health and Clinical Excellence (NICE), the UK's cost containment agency, has updated a draft guideline on familial breast cancer treatments in which it recommends the use of tamoxifen or raloxifene as preventive treatments despite the fact that neither is approved for that indication by safety regulators. The draft, released 15 January 2013, recommends that a patient's physician or oncologist should follow the General Medical Council's (G...
  • 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...