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Pelvic Mesh Complications in Women Before and After the 2011 FDA Public Health Notification

Rice, Nicklaus Trent MD; Hu, Yan MS; Slaughter, James Chris DrPH; Ward, Renee Melva MD

Female Pelvic Medicine & Reconstructive Surgery: November/December 2013 - Volume 19 - Issue 6 - p 333–338
doi: 10.1097/SPV.0b013e3182a330c1
Original Articles

Objectives: On July 13, 2011, the US Food and Drug Administration (FDA) released a public health notification with concerns regarding vaginal mesh for the treatment of pelvic organ prolapse. Our study compares the frequency and type of mesh complications related to female pelvic floor disorders presenting to our center before and after this notification.

Methods: We performed a retrospective cohort study comparing the percentage of women found to have mesh complications related to pelvic floor disorders for the year preceding and the 6 months following the FDA notification. The 2011 International Urogynecological Association/International Continence Society (IUGA/ICS) guidelines were used to classify mesh complications.

Results: We identified 109 women in the 12 months before and 98 women in the 6 months after the FDA notification who presented for new consultation with a history of pelvic mesh placement. Of the women with prior mesh, a higher percentage had a mesh complaint after the FDA notification (31.2% before vs 45.9% after notification; P = 0.029). There was no difference in the frequency of diagnosed mesh complications (38.5% before vs 43.9% after notification; P = 0.435) or the types of complications seen as classified by the IUGA/ICS guidelines. The rate of complications among women with a prior sacral colpopexy (35%) or midurethral sling (30%) was higher than expected for both time periods.

Conclusions: Whereas the number of patient-perceived mesh complications increased after the FDA notification, neither the frequency, type, or location of complications changed. The complications were not limited to transvaginal mesh, and an unexpectedly high proportion of the complications were related to sacral colpopexy and midurethral sling procedures.

More women reported mesh complications in the post-FDA notification period, but the frequency and type of provider-diagnosed complications were unchanged.

From the *Division of Female Pelvic Medicine and Reconstructive Surgery, and †Department of Biostatistics, Vanderbilt University, Nashville, TN.

Reprints: Nicklaus Trent Rice, MD, Division of Female Pelvic Medicine and Reconstructive Surgery, Vanderbilt University, B -1100 Medical Center North, 1161 21st Ave S; Nashville, TN 37232. E-mail: nricemd@gmail.com.

The authors have declared they have no conflicts of interest.

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