AUA 2019: Ten Years After the FDA Warning - Status of Vaginal Mesh
How did we get here?
Transabdominal mesh has been used for POP repair since the 1970s. In the 1990s mesh began to be used for transvaginal repair. The initial reasoning behind the use of mesh for transvaginal POP repair was due to the high recurrence risk of prolapse after native tissue repair of cystocele. It was also less invasive than transabdominal repair, and abdominal hernia mesh augmented repairs were known to be superior to native tissue repairs.
The FDA has three classes of medical devices. Class 1 is the least risk and class 3 is the highest risk. Class 3 devices require a scientific review showing efficacy and safety prior to approval for use. This scientific review is also known as a premarket approval (PMA), and PMA is the FDA’s most stringent device approval pathway. Transvaginal mesh was initially approved as class 2 device because it was thought to be the same risk as mesh used for hernia repair. Therefore, it was approved for use in 2002 without a PMA.
A 2007 Cochrane review looked at 22 RCTs using transvaginal mesh for POP repair. Standard repair was associated with more prolapse recurrences than mesh-based repair. The data on morbidity and complications related to transvaginal mesh for POP were too few for comparisons to native tissue repair and therefore no conclusions were drawn regarding safety in this review. However, an FDA notification in 2008 stated that complications due to transvaginal mesh were higher than expected based on previous data.
In 2011 the FDA released a white paper and safety communication regarding transvaginal mesh for POP. Based on the data available at that time it was determined that there was not enough evidence to strongly establish a risk/benefit profile. The products were subsequently reclassified to a higher risk category (class II to class III), and this category requires PMA. An OB GYN device panel was then convened to evaluate safety and efficacy of transvaginal mesh.
The 2011 FDA notification recommendations were: 1) most cases of POP could be treated successfully without mesh, 2) mesh-based repairs should be used only after weighing the risks and benefits, 3) mesh surgery is more complex, and may require multiple surgeries to address complications, and 4) patients should be notified that mesh would be used in their repair.
Surgeons, in turn, responded to the FDA notification. An AUGS member survey performed in 2012 showed that mesh was used in POP repair by 90% of members prior to 2011, and by 61% after 2011. The legal community also responded to the notification, and after 2011, legal filings against mesh manufacturers increased from 100 per year to 32,296 per year. By 2015, a total of 74,512 product liability lawsuits had been filed, 14% of which were for mesh used in POP repair alone, 63% for SUI, and 23% for combined use of mesh for SUI and POP. In 2012 a new FDA notification came to order manufacturers of TV mesh for POP to conduct post market surveillance. In response, 66% of manufacturers removed their products from the market.
In 2016 an updated Cochrane review included 37 RCTs evaluating the use of mesh for transvaginal POP repair. Awareness of prolapse and rate of repeat prolapse repair were better in the mesh group. However, significantly more patients in the mesh group required repeat surgery for the combined outcomes of prolapse recurrence, SUI, or mesh exposure. The conclusion of this review was that mesh was of limited utility in primary repair.
Where are we now?
In February of this year, an advisory committee was convened by the FDA to obtain input from patients and experts on how to best evaluate transvaginal mesh used for POP. It was concluded that in order to support a favorable risk/benefit profile for transvaginal mesh there had to be evidence that 1) transvaginal repair with mesh is superior to native tissue repair at 36 months and 2) safety outcomes were similar. Then, on April 16th, 2019 the FDA ordered that the remaining manufacturers of transvaginal mesh for apical/anterior compartment prolapse stop selling and distributing their products. This decision was made prior to the completion of 36-month follow up data. Many are concerned regarding what this will mean for slings and sacrocolpopexy mesh. It is noted that the FDA made a distinction between transvaginal mesh for POP repair and that used for slings and sacrocolpopexy. The FDA is now requiring completion of studies to obtain 36 -month follow up data, and the panel will reconsider this decision once the data becomes available.
Presented by: Alvaro Lucioni, MD, Virginia Mason Medical Center, Auburn, Washington
Written by: Dena Moskowitz, MD; Assistant Professor of Clinical Urology; University of California Irvine; @demoskowitz at American Urological Association's 2019 Annual Meeting (AUA 2019), May 3 – 6, 2019 in Chicago, Illinois