Are These Medical Devices Too Dangerous? (Transvaginal Mesh)

Posted in Regulatory and Compliance by Jamie Hartford on April 9, 2014

Transvaginal Mesh

From 2006 to 2009 FDA received more than 1000 adverse event reports about the mesh products used in transvaginal surgical repair of pelvic organ prolapse and stress urinary continence. Problems ranged from pain and infection to mesh erosion and recurrence of prolapse or incontinence.

Activists Say:

Even the FDA seriously questions the safety and effectiveness of these mesh products, so they should be removed from the market immediately.”

Michael Carome, deputy director of Public Citizen’s Health Research Group

Industry Says:

While we are always concerned when a patient experiences an adverse medical condition, TVT continues to be a safe and effective option for women suffering from the debilitating effects of stress urinary incontinence.”

Matthew Johnson, spokesman for Ethicon, maker of the Gynecare TVT pelvic mesh product

FDA Actions:

2008: Issued public health notification and additional patient information on complications associated with transvaginal placement of surgical mesh to treat POP and SUI.

2011: Updated safety communication warning providers and patients that surgical placement of mesh through the vagina to repair POP or SUI may expose patients to greater risk than other surgical options. Obstetrics & Gynecology Devices Advisory Committee recommended vaginal mesh for POP be reclassified as Class III from Class II but that vaginal mesh for SUI remain Class II.

2012: Ordered postmarket surveillance studies by manufacturers to address safety and effectiveness concerns.

2013: Updated Urogynecologic Surgical Mesh Implant site to include more information for patients about SUI.


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