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FDA ISSUES NEW SAFETY COMMUNICATION ABOUT THE USE OF MESH TO TREAT PELVIC ORGAN PROLAPSE

On July 13, 2011, the U.S. Food and Drug Administration (FDA) issued a new safety communication about the use of mesh for pelvic organ prolapse (POP) surgery. This warning is an update of a previous FDA warning that was issued in October 2008. Based on continuing adverse event reports that have been received by the FDA since the initial warning in 2008, the FDA now states that serious complications associated with surgical mesh for transvaginal repair of POP are not rare. In addition, the FDA conducted a systematic review of the published literature from 1996-2011, and concluded that transvaginal POP repair with mesh does not improve symptomatic results or quality of life when compared with non-mesh repairs, and that mesh used for POP repair introduces risks that are not present in traditional non-mesh surgery. Mesh erosion and contraction (shrinkage) were identified as specific complications which can result in pelvic pain, dyspareunia, bleeding and infection.

The FDA then issued new recommendations, which state that healthcare providers should:

  • Recognize that most cases of POP can be treated successfully without mesh
  • Choose mesh surgery only after weighing the risks and benefits of surgery with mesh vs. all other alternatives
  • Consider that surgical mesh is a permanent implant which can make future POP repairs more challenging, can cause complications which require additional surgery, and can be difficult or impossible to remove
  • Inform patients about treatment alternatives that do not require mesh placement
  • Notify patients that mesh will be used, and provide the patient with information about the specific product used
  • Ensure that the patient understands the risks of mesh surgery and the limited long-term outcomes data

Importantly, the FDA explicitly states that the announcement only pertains to the use of transvaginal mesh for POP, and does not concern the use of mesh for the surgical treatment of stress urinary incontinence.

This announcement reinforces the importance of discussing the potential for these complications with prospective patients prior to performing POP surgeries that utilize mesh, and of documenting that discussion in the patient's medical record.

For more information, the FDA report can be viewed here:
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm

Contact:
Wendy Waldsachs Isett, AUA
410-977-4770
wisett@AUAnet.org


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