• Regulatory NewsRegulatory News

    FDA Halts All US Sales of Surgical Mesh

    Following thousands of patient lawsuits and a spike in adverse event reports, the US Food and Drug Administration (FDA) on Tuesday ordered the manufacturers of all remaining surgical mesh products indicated for the transvaginal repair of pelvic organ prolapse (POP) to stop selling and distributing their products in the US immediately. Since FDA reclassified surgical mesh products to class III (high risk) in 2016, the agency said the two manufacturers, Boston Scientific ...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: Australia Bans Transvaginal Mesh Products (5 December 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. Australia Bans Transvaginal Mesh Products Following Risk-Benefit Review Australia has banned transvaginal mesh products used in the treatment of pelvic organ prolapse. The Therapeutic Goods Administration (TGA) took the action after concluding the risks of the controversial treatment outweigh the benefits. Patients and healthcare experts around the world have questi...
  • Regulatory NewsRegulatory News

    Use of Transvaginal Mesh Fell After Strongly-Worded FDA Safety Alert, Study Finds

    Two safety communications issued by the US Food and Drug Administration (FDA) had different impacts on the use of surgical mesh to treat pelvic organ prolapse (POP), according to a recent study appearing in JAMA Internal Medicine . The first look at the use of surgical mesh in New York between 2008 and 2011 found that use actually increased after FDA's first safety communication, from 21% of all procedures in 2008 to 30% in 2011. However, the use of surgical mesh later ...
  • Regulatory NewsRegulatory News

    FDA Increases Regulatory Requirements for Transvaginal Mesh

    The US Food and Drug Administration (FDA) announced Monday that it is increasing regulatory oversight of transvaginal mesh after receiving thousands of reports of injuries, including pelvic pain and bleeding, caused by the devices. Various types of surgical meshes have been in use since the 1950s, and in 1992, FDA cleared the first transvaginal mesh to repair pelvic organ prolapse (POP) as an alternative to native-tissue repair. Under two final orders that take effect T...
  • 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...
  • 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,...