Surgical Mesh Kits – Tighter Regulations

The University of Utah in 2009 published a study conducted by the National Institute of Health and the Pelvic Floor Disorders Network that indicated as many as 1 in 9 women go through pelvic prolapse surgery each year. This surgery, already risky to a woman’s future pelvic health, can be further complicated if the surgical mesh kit being utilized fails to meet common safety standards established by the FDA. While most surgical mesh kits, commonly those used in operations for urinary incontinence, meet the established guidelines, others used in the more delicate procedure for pelvic prolapse fail to perform as expected. Women who are outfitted with these poorly designed kits are at risk of developing further complications, such as displaced mesh and significant levels of pain that can only be relieved by more surgery.

In fact, with the 510 (k) clearance process, the kits used for both types of pelvic operations are typically expedited through the review and inspection procedure. This procedure is designed to get the products to the market immediately so that patients can get the medical help they need right away. However, while this expedited review does not seem to affect the kits used for incontinence, it does adversely affect those that are needed for prolapse surgery. The FDA now stipulates that the prolapse mesh kits must be inspected more thoroughly to help patients avoid complications from their procedures.

The primary inspection of the prolapse mesh kits should help regulators ensure that the mesh is shaped properly for pelvic prolapse repair. Both kits until now feature mesh that was shaped the same. While the shape appeared to work well for urinary incontinence, it failed to work as expected in prolapse repair operations. Women outfitted with this poorly shaped mesh were found to suffer from complications like the mesh slipping out of place to perforations that caused excruciating pain. In fact, so many women suffered complications that the Huffington Post now reports that “thousands” of lawsuits against surgical mesh kit manufacturers have been filed, with one woman in California recently being awarded more than $5 million in damages by a state court.

With the FDA mandates, however, these lawsuits could come with less frequency as patients receive better care and suffer fewer post-surgical side effects. Major manufacturers, including Johnson & Johnson, report that their kits already meet the new safety guidelines and are ready for use today. These new mandates and continuing FDA monitoring could be vital to women who want to avoid the life-changing consequences experienced by other patients in the past.