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    Use of biologic grafts in pelvic organ prolapse surgery

    Biological grafts may be useful in certain patients but long-term trials are needed to guide their proper use.

    Pelvic organ prolapse (POP) is a very prevalent condition, affecting up to half of all women over 50 years old.1 Results from the Women’s Health Initiative suggest that up to 33% of parous women have a clinically significant cystocele; 18% have rectoceles; and 14% have either uterine or post-hysterectomy vaginal vault prolapse.2 Although many patients with POP are asymptomatic and may not require treatment, a recent study by Wu et al. demonstrated that the lifetime risk of surgery for POP among women in the United States is 12.6%.3

    Mesh controversy regarding prolapse

    Pelvic reconstructive surgeons frustrated with high recurrence rates with traditional (or so-called “native tissue”) repairs took the lead from general surgeons who reported improved success rates in inguinal hernia repairs by using synthetic mesh to augment their repairs.4 Starting in the early 2000’s, many reports in the literature suggested that synthetic mesh used for POP decreased failure rates.5-7 On the other hand, reports began to surface that the use of synthetic mesh was associated with complications, such as mesh exposure, pelvic pain, and dyspareunia. In 2008, the US Food and Drug Administration (FDA) came out with a Public Health Notification (PHN) stating that the use of synthetic mesh for prolapse was associated with these and other potential complications.8 The FDA made several recommendations to pelvic surgeons, including specialized training, improving the informed consent process, and providing labeling information to patients. In 2011, the FDA published a Safety Update, which essentially stated the same information contained in the PHN, but went further by stating the incidence of such complications was “not rare.”9

    Related: The future of treating pelvic organ prolapse

    It is important to note that the FDA did not withdraw any of the commercially available mesh kits on the market. Rather, the FDA took action to demand that medical device companies that wanted to keep their prolapse products on the market perform post-market surveillance studies. Although the FDA also recognized that full-length midurethral slings (both retropubic and transobturator) were well-studied and did not require any additional studies, they did mandate that companies that were marketing single incision slings also needed to conduct post-market surveillance studies (“522 studies”) to evaluate the success and potential complications of such devices. The FDA also decided to include manufacturers of xenografts (animal-derived grafts) that were marketing their products for POP to conduct these studies. Interestingly, the FDA did not require manufactures of allografts (human cadaveric tissue) to run these studies.

    Advantages of biologics

    One can clearly see why interest in use of biologic grafts has been increasing since the FDA notifications regarding transvaginal mesh. Surgeons performing surgery for POP may be reluctant to use synthetic mesh, but are still looking for ways to decrease failure rates when they have patients who are at risk of failure with native tissue repairs. Patients who may have an increased risk of recurrence include those with advance stages of prolapse, those who have failed previous native tissue repairs, and women with chronically increased intra abdominal pressure, such as those with obesity, chronic constipation, and occupations or hobbies that require heavy lifting.

    All biologics are not equal

    It is easy to assume that if 1 biologic graft demonstrates success (or failure, for that matter) in treating prolapse, then this should apply to all biologic grafts. One cannot, however, make this assumption, since there are several important differences between these grafts. Grafts differ in their origin (autograft, allograft, xenograft), source (eg, dermis, fascia, pericardium, small intestinal submucosa), life stage (fetal, adult), proprietary processing (eg, washes, enzymes, chemicals, lyophilization), cross-linking (eg, gluteraldehyde) and sterilization (eg, ethylene oxide, gamma irradiation). Each of these variables may influence the behavior of the graft post-implantation, including degredation, long-term success rate, and complications.

    Cross-linked = permanent

    The process of cross-linking biologic grafts changes the absorption profile of the graft, so that biologic grafts act more like synthetic materials that do not resorb or even remodel with host tissue. One of the cross-linked grafts that was previously available was PelvicolTM (Bard, Covington, Georgia) which was marketed for pelvic floor repair. The body’s response to PelvicolTM was to encapsulate the material, and there are reports of seroma formation and wound separations after vaginal repairs with PelvicolTM that required removal of the graft.10-12

    NEXT: Remodelable grafts

    Peter Rosenblatt, MD
    Dr Rosenblatt is an obstetrician/gynecologist in Cambridge, Massachusetts and is affiliated with Mount Auburn Hospital.
    Emily Von Bargen, DO
    Dr Von Bargen is a Clinical Instructor and Associate Fellowship Director in the Division of Female Pelvic Medicine and Reconstructive ...


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