The FDA plans to hold an advisory committee meeting in February 2019 to discuss the safety and efficacy of surgical transvaginal mesh as a treatment for pelvic organ prolapse.
According to a document from the U.S. regulatory watchdog, the committee will be tasked with assessing the benefits and risks of placing mesh transvaginally in the anterior vaginal compartment, as well as clarifying the appropriate patient group and physician training needed for those products.
The meeting will be open to the public, the FDA said, and the agency is requesting comments.
Earlier this year, reports surfaced that Johnson & Johnson (NYSE:JNJ) tried to stop health authorities in France from publishing a report that warned against the use of untested pelvic mesh devices.
Also this year, Ireland temporarily suspended all transvaginal mesh procedures for the treatment of stress urinary incontinence or pelvic organ prolapse at Health Service Executive funded hospitals.
The country said that the suspension will stay in place “until a set of conditions to mitigate the risks of injury are met.”
Ireland’s Minister for Health, Simon Harris, said that the Department Chief Medical Officer requested the suspension following a review by the Dept. of Health, HSE and the Health Products Regulatory Agency.
