pelvic vaginal mesh stress urinary incontinence Polypropylene vaginal mesh

FDA Halts All Sales of Pelvic Mesh Products Tied to Injuries in Women

The U.S. Food and Drug Administration on Tuesday announced a ban on the sale of all pelvic mesh products. The surgical mesh is typically used to repair pelvic organ prolapse (POP) and incontinence, but reported side effects have included permanent incontinence, severe discomfort and an inability to have sex. “In order for these mesh devices to stay on the market, we determined that we needed evidence that they worked better than surgery without the use of mesh to repair POP,” said Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health. “That evidence was lacking in these premarket applications, and we couldn’t assure women that these devices were safe and effective long term.” Read more.

Source: HealthDay News, April 16, 2019

New Vaginal Mesh Material Could Help Thousands of Women Affected By Life Changing Complications

Scientists from the University of Sheffield have developed a material that could be used as an alternative to the current vaginal mesh material, polypropylene, used to treat pelvic organ prolapse and stress urinary incontinence. The use of these current meshes, in particular surgical procedures, has led to severe complications for millions of women across the world and is now banned in Australia. The research conducted by the University of Sheffield, published today in the journal Neurourology and Urodynamics, provides evidence which supports the use of a softer and more elastic material better suited for use in the pelvic floor and one that releases oestrogen into the surrounding pelvic tissue to form new blood vessels and ultimately speed up the healing process. Read more.

Source: EurekAlert, February 13, 2018

surgeons perform pelvic organ prolapse surgery

New Zealand’s Medsafe regulatory body removes pelvic mesh products from market

New Zealand’s regulatory body Medsafe has taken steps to remove a number of surgical mesh products from the country, according to a release posted today. The agency said the product’s removal was the outcome of a recent regulatory action on surgical mesh products, specifically those designed for treating pelvic organ prolapse via transvaginal implantation and one mini-sling product designed to treat stress urinary incontinence. Medsafe said that last December it requested safety information from four surgical mesh suppliers in New Zealand, following action taken by Australia’s TGA as it looked to review meshes used for urogynaecological use. The earlier TGA’s investigation ended in regulatory actions to remove the devices from the market, MedSafe said, and similarly resulted in their removal from New Zealand’s market. Read more.

Source: +Mass Device, January 31, 2018