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Editorial DECEMBER 2006
Transvaginal
Reconstructive Mesh: The Evidence
Is LackingÉ
Linda Brubaker, MD, MS
Recently, Grimes and Nanda1 argued that the use of magnesium as
a tocolytic agent must stop, citing the lack of scientific validation
for either initial or continuing utilization. Moreover, they noted
mounting evidence of a significant potential for harm.
The balance between risk and benefit is at the core of the practice
of medicine, and patients rely on us as clinicians to ethically
weigh this balance when we make recommendations for their care.
However, now I foresee another “magnesium”-type problem
looming in gynecology: routine use of permanent mesh for transvaginal
prolapse repair.
Over the past several years, a growing number of surgeons have
adopted the routine transvaginal placement of permanent vaginal
mesh for primary prolapse repair. However, there is even less evidence
to support this practice than the data justifying magnesium tocolysis.
Why is this happening, and can it be prevented?
Permanent mesh has a well-established use in reconstructive surgery
in terms of abdominal placement during sacrocolpopexy. This procedure—typically
reserved for women with recurrent prolapse—has excellent
anatomic outcomes when weighed against the morbidity of traditional
abdominal surgery. Even in the setting of this “clean” mesh
placement, though, foreign-body complications can occur.
There is a long tradition of reconstructing the prolapsed vagina
via the vaginal route, and it is logical to seek an improved vaginal
technique that can achieve the excellent anatomic outcomes of abdominal
mesh placement without the associated morbidity. While some surgeons
choose to perform laparoscopic and robotic sacrocolpopexy, others
are embracing untested and unproven techniques that may put patients
at significant risk. However, despite the proliferation of materials
and kits, there is no evidence that routine transvaginal placement
of permanent mesh for primary prolapse repair improves the outcome
compared with traditional vaginal repair. In fact, specialists
are seeing a growing number of serious complications arising from
this procedure, including difficult-to-repair fistulae; life-threatening
hemorrhage; and severe, refractory dyspareunia. These problems
cannot be resolved via simple excision of the exposed mesh; rather,
these patients typically require a series of operations to even
restore their baseline status, let alone resolve the original problem
for which they sought care.
How can a physician know whether a new procedure is better than
current practice? When most prolapse operations were initially
described, the use of clinical trials was virtually unknown. Today,
however, there is an abundance of clinical investigators—both
in our profession and in the for-profit industries that develop
these materials. Appropriate clinical trials can and should be
funded, and the outcomes should be widely publicized prior to any
marketing. No individual physician can conduct such an assessment
alone, but every surgeon can make a commitment on our patients’ behalf
to insist that new technology is well supported by data. Physicians
must ensure that they are making every reasonable effort to identify
the best procedure for each individual woman.
In addition to seeking preventive measures for recurrent prolapse,
there is no question that therapy must be improved. However, evaluations
of “better” surgical treatments merit the same scientific
rigor that is required for new medications—ie, large clinical
trials and large cohorts with independent assessments that can
contribute significant early information about safety and efficacy.
If the surgical community does not demand a high quality of information,
rather than adopting unproven techniques before adequate scientific
assessment, then we are letting our patients down.
Many new developments in reconstructive surgery represent significant advances in the care of women with pelvic organ prolapse. But unless surgeons insist on validation, Drs Grimes and Nanda will soon be writing another editorial urging us to stop routine placement of permanent mesh in transvaginal prolapse repair.
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Linda Brubaker, MD, MS, is Assistant Dean for Clinical and Translational Research;
and professor, Department of Obstetrics and Gynecology & Urology, Stritch School of
Medicine, Loyola University,
Chicago, Ill
References
- Grimes DA, Nanda K. Magnesium sulfate tocolysis: time to quit. Obstet
Gynecol. 2006;108(4): 986-989.
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