Transvaginal mesh for prolapse: Where are we in 2016?

OBG Management: How do the new types of mesh differ from those that have been removed from the market?
Dr. Iglesia: In January 2012, there were about 40 types of surgical mesh available from more than 30 manufacturers of transvaginal mesh. At that time, the FDA imposed 522 orders on these companies, requiring them to provide up to 3 years of postmarket data on the safety and effectiveness of their devices.⁹ Some companies ceased production, including Johnson and Johnson and CR Bard. Today, there are about a half-dozen mesh types on the market, and these are undergoing evaluation.

First-generation meshes were the size of a sheet of paper; now, meshes can fit on the palm of your hand. They also do not have the legs or the arms that are placed using trocars through the transobturator or ischioanal fossae, which can approach nearby nerves, arteries, or other vital structures. They are significantly lighter weight, and some have color to make the native tissue and mesh interface more apparent.

Mesh contraction,¹⁰ inflammation of the mesh involving surrounding soft tissue,¹¹ and stress shearing at the mesh/soft tissue interface¹² have been implicated as potential causes of pain with synthetic mesh. The most commonly available synthetic mesh today is type 1 polypropylene (macroporous monofilament), with a large pore size (usually greater than 75 microns).

Non−cross linked biologic grafts also are available currently, with several cross-linked grafts removed from the market by 2013 because their design was associated with graft stiffness and shrinkage, which had the potential to distort the pelvic anatomy.

Non−cross linked biologic grafts may be associated with fewer mesh-related complications compared with synthetic mesh, but there are limited data on their use in POP repair and there are many unanswered questions. The current concerns with biologics are their tensile properties, foreign body reactions, and documented autolysis. Modifications to them may affect their soft tissue reactivity, but outcomes depend on the technique used for implantation.

OBG Management: When do you consider vaginal mesh use for prolapse?
Dr. Iglesia: A recent Cochrane review shows that some data favor mesh for decreased recurrence, but there are trade-offs.¹³ I consider mesh use in the setting of recurrent prolapse, especially anterior, for advanced-stageprolapse, and under certain situations, including when there is a known collagen deficiency and there are contraindications to abdominal surgery. However, pelvic pain always is a concern, and surgeons should be extremely careful when choosing to use mesh in patients with known chronic pelvic pain.

The FDA recommends that clinicians treating patients with POP recognize that POP can be treated successfully without mesh and that this native tissue repair will avoid completely the risk of mesh-related complications (TABLE 1).¹⁴ Patients should be made aware of alternatives to vaginal mesh when deciding on surgical repair, including nonsurgical options, native tissue repair, and abdominally (laparoscopic, robotic, or open) placed sacrocolpopexy mesh.

OBG Management: How does the Pelvic Floor Disorders Registry solve issues that existed prior to the mesh controversy?
Dr. Iglesia: The Pelvic Floor Disorders Registry (PFDR), which can be accessed online (http://www.pfdr.org), is a private and public collaboration including many medical societies: the American Urogynecologic Society (AUGS), the American College of Obstetricians and Gynecologists, the American Urologic Association, the National Institutes of Health, the FDA, and industry. Its objectives are 3-fold¹⁵:

All involved PFDR partners, which also includes patient advocates, reached consensus on the outcomes that matter scientifically in terms of objective cure rates and complications as well as on subjective outcomes that matter most to patien

Quite frankly, subjective patient-reported outcomes probably trump any other outcome because, in general, patients are risk averse—which is to say that they are much more easily accepting of recurrence or failure than of a serious adverse event from a mesh-related complication. With the PFDR, we are able to capture not only that objective data but also the critically important patient-centered outcomes.¹⁶

With the PFDR, a patient who goes to surgeon B following a complication with surgeon A can still be followed. I look forward to the tracking capability within the registry and the many prospective comparative trials that can be conducted.

Unfortunately, differences between older and newer transvaginal mesh delivery systems will not be evaluated as part of the required 522 studies within the PFDR; however, I really look forward to seeing the data roll out on the second generation vaginal mesh kits compared to native tissue repai