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    Australia’s TGA Opens Review of All Surgical Mesh Devices

    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. Australia’s Therapeutic Goods Administration (TGA) has announced that it will initiate the reassessment of the clinical evidence for all urogynecological surgical mesh implants to determine if they comply with the requirements for safety and performance necessary for ma...
  • Snowstorm Costs Device Company a Million Dollars

    For most people, a snowstorm costs them time digging out their car or a sore back from shoveling. But for medical device manufacturer STAAR Surgical, a February 2014 snowstorm wound up costing it about one million dollars. How, you ask? The company was scheduled to meet with a US Food and Drug Administration (FDA) Advisory Committee on 14 February regarding a premarket approval (PMA) application for its Toric ICL intraocular implant. FDA's advisory committees provide th...
  • FDA Cracks Down on Transvaginal Mesh, Will Require Companies to Submit Data or Pull Products

    The US Food and Drug Administration (FDA) has announced that it will seek to regulate transvaginal mesh products more stringently, calling them high-risk devices that will be required to undergo FDA's thorough premarket approval (PMA) process. Background Transvaginal mesh has been used to treat female urological conditions, and in particular those caused by weakened pelvic muscles, which can lead to a pelvic organ prolapse (POP). In the EU, they have been used since the...
  • EU Launches Probe into Safety of Transvaginal Mesh

    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 it is launching an investigation into the safety of transvaginal mesh products used in urogynecologic surgery. Background Transvaginal mesh has been used to treat female urological conditions, and in particular those caused by weakened pelvic muscles, which can lead to a pel...
  • J&J Announces Planned Cessation of Vaginal Mesh Sales

    Johnson & Johnson subsidiary Ethicon announced on 5 June 2012 it will cease sales of a controversial line of vaginal mesh implant products after being hit with a series of lawsuits alleging the products cause internal bleeding. Bloomberg Businessweek reports the company has requested approval from the US Food and Drug Administration (FDA) to end sales of the product within the next 120 days so consumers and doctors can find alternate suppliers or other treatment op...
  • CGMP Violations Could Lead to Three Years in Jail for Former Medical Device Executive

    The US Food and Drug Administration's (FDA) Office of Criminal Investigations and the US Department of Justice (DOJ) have announced the indictment of William Zinnanti, the former President and Owner of Zinnanti Surgical Design, for selling devices to hospitals in violations of current Good Manufacturing Practices (cGMPs). According to a 15 May statement released by DOJ, Zinnanti Surgical Design manufactured a non-sterile surgical device used primarily in hospital setting...
  • Bloomberg: J&J Sold Unapproved Medical Device for Years Prior to Approval

    Life sciences manufacturer Johnson & Johnson sold its now-controversial vaginal mesh implant for three years prior to being approved by the US Food and Drug Administration (FDA) in 2008, reports Bloomberg . The unauthorized sale of the Prolift vaginal mesh implant product, manufactured by Johnson & Johnson's Ethicon unit, could place the 510(k) approval pathway under additional scrutiny. The company marketed Prolift as early as 2005, reports Bloomberg , reason...
  • Poll: Public In Favor of Increased Medical Device Regulation

    A poll commissioned by industry watchdog group Consumer Reports indicates the vast majority of consumers are in favor of a risk-averse regulatory framework for medical devices , giving ammunition to the group at a time when it is seeking to influence the debate over the reauthorization of the Medical Device User Fee Act . Consumers Union has taken the position that medical devices-particularly those cleared through the US Food and Drug Administration's (FDA) 510(k) pat...
  • FDA Orders Surgical Mesh Manufacturers to Study Risks

    The US Food and Drug Administration (FDA) issued a safety communication yesterday warning consumers about problems associated with surgical mesh implants and ordering manufacturers of the devices to conduct new studies in light of those safety concerns. The mesh, used to treat pelvic organ prolapse and stress urinary incontinence , has been associated with pain, infections, urinary problems, bleeding and discomfort .  FDA said that it has received more than 1,...