Adverse events associated with the use of synthetic mesh in pelvic organ prolapse (POP) reparative surgery – and the Food and Drug Administration’s safety communication in 2011 warning physicians and patients about transvaginal placement of mesh for the repair of POP and stress urinary incontinence – have had a significant impact on gynecologic surgery.
Many physicians have become reluctant to use synthetic mesh products because of the risks of mesh erosion, exposure, pain and dyspareunia, and litigation. Patients also are concerned or even alarmed by reported risks. Moreover, some manufacturers have become increasingly concerned with the production of mesh products for POP repair, lessening the availability of synthetic mesh, and possibly some biologic mesh as well, for POP reparative surgery. Overall, the future of mesh augmentation in POP repair is uncertain.
Vaginal mesh procedures had surged in the decade prior to 2011 despite the lack of good randomized studies to determine whether mesh augmentation was truly efficacious. And unfortunately, the FDA has grouped synthetic and biologic material together in its reviews and notices of mesh products for POP repair. Not classifying and investigating them separately can mislead patients and hinder the development of randomized controlled trials needed to determine if augmentation with biologic material is truly superior to traditional POP repair using native tissue.
Comparing biologic mesh products to synthetic materials for pelvic organ prolapse repairs is like comparing apples to oranges: Synthetic mesh is permanent, while most biologics break down and remain in the body no longer than 6 months. From the standpoint of complications, this gives biologic materials an advantage. In my practice, biologic grafts have not eroded or caused pain, dyspareunia, or postoperative infections in any of my patients who have had surgical repair for POP.
There remains a real need for augmentation of weakened collagen tissue in the repair of POP. The native tissue in these patients is faulty tissue. Without reinforcement of defective tissue, we cannot expect excellent repairs. Data from nonrandomized studies have borne this out. When I talk with my patients about the options for surgical correction of POP, I tell them that success rates without the use of any augmentation are low, and that only about 60% of patients achieve a satisfactory result with traditional repairs.
Increasingly, I and other gynecologic surgeons are having success with biologic materials in our POP repairs. Efficacy needs to be measured in well-controlled randomized clinical trials, but at this point it appears anecdotally and from nonrandomized case reports that we can achieve good anatomic outcomes – upwards of 80% success rates – with biologic grafts, without the complications of synthetic mesh.
A recent survey of members of the American Urogynecologic Society shows that the use of synthetic mesh in transvaginal POP surgery decreased significantly after the 2011 FDA safety update, while there was no significant change in the use of biologic graft for POP (Female Pelvic Med. Reconstr. Surg 2013;19:191-8). It may be that the tide will shift toward greater use of biologic grafts. At the least, gynecologic surgeons should appreciate the differences between the two types of materials.
In the meantime, transvaginal placement of synthetic mesh should be used carefully and sparingly, with proper attention paid to patient selection and technique to reduce as much as possible the risk of erosion and pain.
In either case, more attention should be paid to the prevention of postoperative infections. Postoperative infection is an underappreciated risk with pelvic reconstructive surgery overall, and the use of synthetic mesh significantly increases this risk. Biologics are safer from an infection standpoint, but proper prevention – including evaluating each patient’s vaginal microflora immediately preoperatively and treating patients accordingly – is important for any surgery.
My advice on synthetics
Selecting patients for POP repair with no mesh, biologic mesh, or synthetic mesh requires thorough patient counseling. This is best done over multiple visits, with the patient reviewing information and coming back for a subsequent visit 1-2 weeks later with questions. She must be prepared psychologically and have realistic expectations.
In its 2011 safety communication, the FDA stated that the main role for mesh with POP repair is in the anterior compartment, and that traditional apical or posterior repair with mesh does not appear to provide any added benefit, compared with traditional surgery without mesh. Rectocele repair should not preclude the use of mesh, however, especially when a prior nonmesh repair has failed. For a patient with a small rectocele, I would advise repair with native tissue, and a second surgery with augmentation if the initial repair fails.