Dr. Iglesia noted that a tracking mechanism for the individual products is important because there have “clearly” been some devices with higher complication rates than others. Formal physician training specific to each individual mesh product, and determining how many cases need to be performed to gain and maintain competence is also important to ensure that these devices are used safely, she said.
Dr. Iglesia, associate professor of obstetrics, gynecology, and urology at Georgetown University, Washington, said that while physicians do not need to treat patients who have had vaginal mesh implanted for POP and are asymptomatic, these patients should be monitored for potential complications. Many patients have contacted their physicians in a panic, after hearing about the reports of complications, she said, “but the vast majority of patients are fine, although they do need to be seen by their physician if they develop symptoms,” such as bleeding, pain or discharge, or if their partner feels something during intercourse.
The use of vaginal mesh for POP has increased since 2004; only about 20% of the estimated 100 synthetic mesh devices or mesh kits that have been cleared for use for POP surgery are being actively marketed, according to the statement.
The statement does not address the use of synthetic mesh used for abdominal or minimally invasive sacrocolpopexy or for midurethral slings to treat stress urinary incontinence.
All ACOG committee members are required to follow the college's guidelines for relationships with the health care industry, according to the ACOG website. Dr. Iglesia said she had no disclosures.
The 2011 FDA advisory is available at http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htmwww.fda.gov/MedicalDevices/Safety/ReportaProblem/FormsandInstructions/default.htm
'Women and their doctors really need to weigh the risks and benefits before deciding on a course of action.'
Source DR. IGLESIA