Surgical Mesh Kits May Be Regulated More Closely

The FDA recently issued proposals to confront the health risks patients face with transvaginal mesh surgery.

The proposals target the transvaginal repair of pelvic organ prolaps (POP). If the proposals are finalized, transvaginal POP would change from a moderate-risk device (class II) to a high- risk device (class III).  High-risk devices require the manufacturers to submit premarket approval applications to the FDA so their safety and effectiveness are evaluated.

Transvaginal repair of pelvic organ prolapse occurs when organs such as the bladder, uterus and bowel drop from their normal position and prolapse into the vagina.  The quality of life for women experiencing losses and injuries from POP change dramatically.

The FDA has been evaluating cases and reports in regards to complications of this device.  There has been reports of errosion, mesh shrinkage and migration from implantation site causing significant and chronic pain.

Zoll, Kranz & Borgess represents victims with transvaginal mesh injuries.   For more information about your legal rights, contact our experienced MDL and defective medical device lawyers by calling toll-free (888)841-9623 today

Source: http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm395192.htm