The following article will
give the reader a comprehensive overview of the FDA’s communications to date concerning
surgical mesh when used transvaginally in pelvic organ prolapse surgeries. The
article An Appraisal of the Food and Drug
Administration Warning and Urogynecologic Surgical Mesh, published in the
Current Urology Reports (2012, 13:231-239) gives an overview of the FDA’s
conclusions regarding the use of surgical mesh in POP surgeries. The first Public
Health Notification issued by the FDA came out in 2008 after over a thousand
women submitted adverse health reports following transvaginal surgery using
gynecologic mesh. Three years later the FDA issued an update to that report
regarding the safety and effectiveness of mesh in POP surgery. At this time the
agency reviewed the currently available safety data and scientific research on
gynecologic mesh.
This article states that it is
estimated that over a third of pelvic organ prolapse surgeries implement
surgical mesh and that 75% of all these surgeries were done transvaginally.
These numbers come from the over 300,000 women who undergo pelvic organ
prolapse surgery annually in the U.S. and over 260,000 who undergo a surgical
procedure for stress urinary incontinence. The FDA states that as far as SUI
surgeries go, “more than 80% were done
transvaginally with mesh.” The FDA’s conclusion is that although POP
surgery done transvaginally may restore the woman’s body anatomically, there
are few if any benefits over surgeries which do not implement urogynecologic
mesh.
The Current Urology Reports
article lists a number of bullet points set forth by the FDA concerning the
safety and efficacy of surgical mesh. Regarding the efficacy of the use of
urogynecologic mesh in pelvic organ prolapse surgeries, the FDA believes there
are no added benefits when using mesh for apical posterior or transvaginal
repairs over older techniques which don’t use mesh. Reviews of mesh kits used
during an apical repair might appear to be effective a short time following the
surgery but long-term results are unknown.
While anatomic benefits are
noted when mesh is used in anterior repair, the negative health symptoms which
follow the surgery as well as the likelihood of a repeat surgery are routinely
seen. Those who push the use of transvaginal mesh do so under the guise of an
improved quality of life for women, however statistics simply don’t bear this
out. Women who have pelvic organ prolapse surgery using a mesh device show no
improvements in quality of life following the surgery as compared to those
whose surgery did not include surgical mesh. When abdominal apical prolapse is
surgically repaired with mesh, and compared with older surgical procedures
which do not use mesh, recurrence appears somewhat less likely.
Transvaginal Mesh Safety Issues
The principal point made by
the FDA regarding surgical mesh safety is that a large number of complications
are experienced by those women who undergo pelvic organ prolapse surgery which
implements surgical mesh as compared to those women whose surgery does not
include the use of surgical mesh. Complications associated with the use of
surgical mesh in transvaginal pelvic organ repairs are not especially rare, and
it is believed that over 10% of all women who undergo this particular surgical
procedure will experience erosion by the end of the first year. At least half
of those will undergo surgery to remove the mesh; many women whose surgery
included the use of mesh have noted shortening of the vagina, tightening and
vaginal pain—all which hinder or preclude normal sexual intercourse.
Complications are very common among women who undergo surgery to correct
vaginal apical prolapse when mesh is used. These increased numbers of
complications dictate that subsequent operations are necessary in order to
correct the problems. Overall, the FDA states abdominally placed mesh to
correct pelvic organ prolapse suffers fewer problems than transvaginally placed
mesh.
The FDA’s List of Shortcomings of Existing Literature
In the article by Current
Urology Reports there are five shortcomings listed by the FDA regarding the
existing literature on the use of urogynecologic mesh used in the transvaginal POP
repair. One of the shortcomings of this literature revolves around the fact
that many reports on the subject only offer details on the success of the
transvaginal POP surgery—whether “ideal pelvic support” is achieved. Whether or
not the women who underwent the surgical procedure were actually relieved of
their adverse symptoms is rarely reported. Primary surgical procedures are not
separated from repeat surgeries in the overwhelming majority of the literature
therefore it is difficult to get an accurate portrayal of whether the initial
surgery led to a greater number of problems or whether the subsequent surgery
caused additional adverse symptoms.
The current literature also
fails to separate surgeries for stress urinary incontinence from pelvic organ
prolapse, categorizing, defining and reporting adverse events in a very
inconsistent way. The FDA finds the current research and studies done on pelvic
organ prolapse repair using transvaginal mesh are designed poorly or carried
out poorly, using “use incompletely
documented inclusion/exclusion criteria, have inadequate evaluator masking and
fail to account for variable lengths of patient follow up.” Few of the
studies have followed women who have undergone POP surgery which employed
transvaginal mesh for more than two years—a completely inadequate length of
time for a realistic follow-up.
In the end, the FDA believes
that complications are “not rare”
when urogynecologic mesh is used in a transvaginal pelvic organ prolapse
surgery however noted they intend to continue monitoring the overall situation,
reporting their findings at a later date. Erosion is among the most frequent
negative health outcome reported by women; the mesh can erode through the
vagina, bladder or bowel. Infection, pain, excessive bleeding pain during
sexual intercourse, perforation of surrounding organs, urinary problems,
subsequent prolapse, vaginal scarring or shrinkage, emotional trauma and
neuromuscular issues have all been reported by women whose pelvic organ
prolapse surgery implemented the use of surgical mesh and was performed
transvaginally.
Other Stances Regarding FDA Statements
Several comments came from the
American Urogynecological Society regarding the communications from the FDA.
This group felt there should be upgrades made to the 510(k) approval process.
This process currently allows medical devices and drugs submitted for approval
to skip clinical trials if they can show their device or drug is substantially
similar to a device or drug which has already gained FDA approval. Most of the
current surgical meshes and mesh kits approved for use in pelvic organ prolapse
surgeries gained FDA approval under devices which were approved for hernia
repair. The AUGS agrees with the FDA that the majority of pelvic organ prolapse
can be successfully treated without using mesh, greatly decreasing the risks
associated with mesh devices. According to the Current Urology Reports
articles, the AUGS recommends that when surgical mesh use is warranted the
procedure should only be done by highly trained surgeons and patients should be
thoroughly informed regarding the possible risks of surgical mesh. AUGS also
states that a national database which includes all those who undergo surgery
with urogynecologic mesh should be implemented which would allow the FDA to
successfully track both positive and negative outcomes.
As noted in the Current
Urology Reports article another group, The Society for Urodynamics and Female
Urology, stated they would make no sweeping recommendations for or against the
use of transvaginal mesh however they also advise that the FDA review their
current 510(k) process of approval. The American Urological Association
concurs, adding that surgeons who perform this particular surgery must “undergo rigorous training in the principles
of pelvic anatomy and pelvic surgery, be properly trained in specific mesh
implantation techniques and be able to recognize and manage the complications
associated with vaginal mesh.” This article discussed the communications
sent out by the FDA regarding the use of urogynecologic mesh during
transvaginal pelvic organ prolapse surgeries.
Indianapolis Indiana Transvaginal Mesh Lawsuits | Transvaginal Mesh Lawyers
