Category: Transvaginal Mesh

F.D.A. Orders More Studies On The Risks Associated With Transvaginal Mesh

As anticipated, last week the Food and Drug Administration (FDA) issued an order requiring more studies on the risks of transvaginal mesh by manufacturers. Transvaginal mesh – also referred to as vaginal mesh and pelvic mesh – has come under fire after years of reports linking serious injuries to the devices. In September, an F.D.A…. read more

Joint Commission Makes Recommendations On Use Of Transvaginal Mesh

A recent report issued jointly by the American College of Obstetricians and the American Urogynecologic Society details vaginal mesh recommendations, including that the mesh should only be used for certain high-risk women. The safety and efficacy of the synthetic mesh, also known as transvaginal mesh or bladder mesh, has been called in question, making its… read more

Transvaginal Mesh Device Based On Recalled Product

As women across the country continue to suffer complications from the use of Johnson & Johnson’s transvaginal mesh devices, a new report reveals that the design of the bladder mesh was based on recalled transvaginal mesh devices that had been taken off the market more than ten years ago due to safety problems. The devices… read more

Transvaginal Mesh Linked To Serious Side Effects And Complications

The FDA has recently issued an updated transvaginal mesh warning on the use of the mesh to help repair pelvic organ prolapse (POP). POP occurs when the pelvic organs fall out of place as the result of the stretching or weakening of the tissues holding the organs in place. Transvaginal mesh – also known as… read more

FDA Holds Hearings On Transvaginal Mesh

The FDA met last week to determine whether surgical mesh inserted surgically inserted into the vagina, also known as transvaginal mesh or pelvic mesh, needs tighter regulation by the FDA. The mesh is used to treat a painful condition called pelvic-organ prolapse. As the result of close to 3000 reports of adverse events, including seven… read more

FDA Warns Of Risks Associated With Transvaginal Mesh

Recently the FDA issued a transvaginal mesh warning concerning the use of the medical device (also known as pelvic mesh, pelvic sling, or bladder mesh) as a method to repair pelvic organ prolapse. The FDA warning stated that using transvaginal mesh to repair pelvic organ prolapse exposes patients to an “unnecessary risk” without providing any… read more