A Safety Alert Has Been Issued By FDA for Transvaginal Placement of Surgical Mesh: Surgical placement of mesh through the vagina to repair pelvic organ prolapse may expose patients to greater risk than other surgical options.
The FDA has issued an alert informing hospital surgical staff, OB/GYN physicians, other healthcare professionals that complications associated with surgical mesh for transvaginal repair of POP (Pelvic organ prolapse) are not rare. According to the FDA:
The number of adverse events reported to the FDA for surgical mesh devices used to repair POP and stress urinary incontinence (SUI) for the previous 3-year period (2005 – 2007) was “over 1,000.” Since then, from Jan. 01, 2008 through Dec. 31, 2010, the FDA received 2,874 additional reports of complications associated with surgical mesh devices used to repair POP and SUI, with 1,503 reports associated with POP repairs and 1,371 associated with SUI repairs…It is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk.
For more information on the Transvaginal Placement of Surgical Mesh safety alert, read the Food & Drug Administration’s FDA’s drug or medical device recall or safety alert: Transvaginal Placement of Surgical Mesh.
To report an adverse reaction, problem or other issue with surgical mesh, submit a drug or medical device complaint to the government at fda.gov or MedWatch.
If you have thoughts on the Transvaginal Placement of Surgical Mesh recall or safety alert, share your drug or medical device recall or safety alert comments below.