• Breast Ultrasound Device Gets Nod from FDA

    The US Food and Drug Administration (FDA) has approved the first ultrasound device for use in women with dense breast tissue, marking a win for California-based U-Systems Inc. The device, the somo-v Automated Breast Ultrasound System (ABUS), solves a previously intractable problem: How do you accurately detect a dense, tumorous mass when it is suspended in dense tissue? FDA estimates approximately 40% of women have dense breasts, which makes mammograms difficult to inte...
  • Study: Diagnostic Errors Death Equal Breast Cancer Deaths

    • 31 August 2012
    A study by Johns Hopkins researchers claim medical mistakes in the intensive care unit (ICU) kill as many as 40,500 patents per year, as many deaths as breast cancer patients suffer. The researchers examined more than 5,800 autopsy reports from various ICUs. The study said not all missed errors contributed directly to patient death, but that patients in ICU were twice as likely to suffer a fatal misdiagnosis. "Our study shows that misdiagnosis is alarmingly common in th...
  • 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...
  • 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...
  • Capping Busy Week, FDA Approves Breast Cancer, Multiple Myeloma Drugs

    The US Food and Drug Administration (FDA) approved two new drug entities for treating, respectively, certain forms of breast cancer and multiple myeloma on Friday, 20 July. The approvals capped off a busy week for the agency, marking the fourth approval and second new molecular entity in the five-day period. Afinitor (everolimus) , manufactured by Novartis Pharmaceuticals, was approved for the treatment of postmenopausal women with advanced formone-receptor positive, HE...
  • 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...
  • UK: NICE Says No to Two Breast Cancer Drugs

    In final guidance published 27 June, the UK's National Institute for Health and Clinical Excellence (NICE) does not recommend lapatinib (Tyverb, GlaxoSmithKline) or trastuzumab (Herceptin, Roche) with aromatase inhibitors as first line treatment options for metastatic breast cancer. The guidance notes it is unclear how much either drug can improve overall survival compared to existing treatments and as a result they do not represent value for money for the NHS. Th...
  • 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...
  • Investigation Clears Faulty Implants of Most Serious Safety Concerns

    The UK's Department of Health (DoH) has released its second and final report on the role of regulatory authorities in the proliferation of defective breast implant products manufactured by the now-shuttered French medical device manufacturer Poly Implant Prothese (PIP). The review, announced in January 2012 by UK Health Secretary Andrew Lansley, was aimed at "ensuring the safety of people seeking cosmetic interventions" after French authorities discovered PIP had sold ...
  • European Legislators Propose Premarket Approval System for Some Medical Devices

    Legislators of the European Parliament (EP) have proposed more stringent safety measures for implantable medical devices, including implant registries, tougher safety inspections, better product traceability and-perhaps most importantly-a premarket authorization system. The proposed changes come after the discovery of widespread quality issues with now-defunct French implant manufacturer Poly Implant Prothese's breast implant products. The products are purported to have ...
  • FDA Approves New Breast Cancer Drug Despite Manufacturing Concerns

    Genentech's application for Perjeta (pertuzumab ) won marketing approval from the US Food and Drug Administration (FDA) on 8 June, bringing to market a new-and expensive-biologic product for the treatment of advanced breast cancer. Perjeta is a humanized monoclonal antibody, and works in conjunction with Herceptin (trastizumab) to further reduce the growth of HER2-positive cancerous cells in breast cancer patients. The HER2 gene is associated with approximately 20...
  • New FDA Guidance Could See Patients Obtaining Quicker Access to Experimental Therapies

    The US Food and Drug Administration's (FDA) newly released draft guidance on neoadjuvant breast cancer treatments has the potential to radically change the existing pathway through which patients with aggressive early-stage breast cancer can obtain treatment, say experts. The guidance, released on 28 May,  is "intended to assist applicants in designing trials to support marketing approval of drugs to treat breast cancer in the neoadjuvant setting using pathologic co...