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BioWorld - Tuesday, July 5, 2022

Surgical mesh

Home » Topics » Medical devices » Surgical mesh
  • Aug. 16, 2021
    By Mark McCarty

    FDA says studies of BSX mesh OK at 36 months, but lack acceptable benefit-risk profile

    The U.S. FDA said the results of a Section 522 postmarket surveillance study of transvaginal mesh devices by Boston Scientific Corp. suggested similar effectiveness and safety outcomes at 36 months compared to native tissue repair. However, the agency said patients with mesh repair for pelvic organ prolapse (POP) are exposed to additional risks, such as mesh exposure and erosion, and thus the agency is disinclined to allow these devices back onto the market.
  • Us law flag gavel
    April 27, 2021
    By Mark McCarty

    New Jersey court reverses lower court’s decree that issuance of 510(k) is inadmissible in trial

    The FDA’s premarket review mechanisms for class II medical devices may strike some as little more than so much regulatory esoterica, and several courts have ruled that information about the 510(k) process is inadmissible during jury trials due to the possibility of sowing confusion among jurors. An appellate court in New Jersey has ruled that such an exclusion of evidence is prejudicial in a case involving surgical mesh manufactured by two device companies, however, opening a larger debate about the propriety of such exclusions in product liability litigation for medical devices.
  • Oct. 4, 2019
    By Meg Bryant

    Exogenesis gets FDA OK to market first hernia mesh with nano-modified surface

    The FDA has granted 510(k) clearance to the first hernia mesh featuring a nanometer-level surface texture, enabling better post-implant tissue ingrowth and reducing the incidence of adverse reactions. The Exogenesis Hernia Mesh, by Billerica, Mass.-based Exogenesis Corp., is indicated for the repair of abdominal wall hernias and deficiencies that require reinforcement to stabilize the condition and achieve a positive surgical outcome. The company expects to launch the product nationwide in 2020.

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  • Meg Bryant
  • Mark McCarty
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