Vaginal mesh implants are medical devices that are used in surgical correction of pelvic floor disorders in women. Since being cleared by the Food and Drug Administration (FDA), these mesh implants have become very common in pelvic organ prolapse and stress urinary incontinence procedures. However, as the number of procedures done with mesh have increased over the past decade, so too have the rates of serious complications reported to the FDA. These reports have raised questions as to the safety and efficacy of these devices. The FDA has issued safety alerts on these products and has taken regulatory action to place them under increased scrutiny.
Vaginal mesh implants were cleared for use in stress urinary incontinence, or SUI, repair in the 1990s and for pelvic organ prolapse, or POP, repair in 2002. However, this clearance was given under a streamlined approval process, called the 510(k) program, a regulatory path by which many medical devices find their way into the marketplace.
Typically, to have a medical device approved under the program, the manufacturer has no obligation to submit clinical trials as proof of safety and efficacy so long as it can show that the new device has “substantial equivalence” to a device that has already been approved by the FDA.
Since vaginal mesh received that clearance, procedures that use mesh implants to repair POP and SUI have become widely used. According to the FDA, in 2010 alone, about 75,000 POP procedures and approximately 208,000 SUI procedures were done with the use of transvaginal mesh implants. As the number of women treated with vaginal mesh has risen over the past decade, adverse events reports collected by the FDA on these procedures have also increased dramatically.
From these reports, the FDA has determined that there are high rates of serious complications associated with procedures using these devices. This information prompted the agency to issue an official Public Health Notification in October 2008 warning medical professionals and patients of the potential for complications. This was followed by an update on that notification in July 2011, stating that reports of serious complications had risen five-fold since the 2008 alert was issued.
Erosion, Protrusion, Revision Surgery
Among the complications most commonly reported to the FDA were vaginal mesh erosion, protrusion of mesh through vaginal walls, organ perforation, pain, bleeding, infection, neuro-muscular problems, urinary issues, recurrent prolapse, and vaginal scarring and shortening. Mesh shrinkage is an issue that has become prominent as well, which can lead to severe pelvic pain and sexual dysfunction. Hundreds of women affected by these complications have opted to file transvaginal mesh lawsuits.
Many of these complications make revision surgery necessary, in which the doctor may attempt to remove the mesh implant. Many women have had multiple procedures done for that purpose, but still suffer symptoms, since mesh can be very difficult to remove once the body's tissues have grown into and around the implant. The FDA stated in its 2011 update that these procedures have not been shown to have any better clinical results than traditional POP and SUI procedures, and the agency has urged surgeons to consider methods of SUI and POP repair that do not use vaginal mesh. The FDA has yet to mandate a vaginal mesh recall.
Elizabeth Carrollton writes about defective medical devices and dangerous drugs for Drugwatch.com.