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.
Serious Complications
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.
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Elizabeth Carrollton writes about
defective medical devices and dangerous drugs for Drugwatch.com.
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