FDA Considering High Risk Classification for Surgical Mesh

FDA

The makers of surgical mesh may soon have to submit additional safety data to regulators in order to keep their products on the market. New reports have shown that the use of transvaginal surgical mesh has failed to yield better results than non-mesh procedures. The surgical mesh can also pose a higher risk to patients. [...]

FDA Reports Safety Concerns over Transvaginal Surgical Mesh

FDA warning / The Maher Law Firm/ Frank Eidson

The U.S. Food and Drug Administration has issued new warnings regarding the use of transvaginal surgical mesh to treat pelvic organ prolapse. The agency’s warnings are targeted at the placement of the mesh, citing that its use may actually carry greater risk than other surgical options, without any evidence of greater benefit. The number of [...]