Our Greatest Wealth Is Health

Andrew Siegel MD  5/18/2018

60 Minutes Trashes Boston Scientific and Pelvic Meshes

Last Sunday, a piece aired on the CBS weekly 60 Minutes concerning Boston Scientific meshes that are used in the field of female urology. The segment was spun in such a way that many viewers were likely to get the wrong impression about Boston Scientific products that are used for two common pelvic floor issues–stress urinary incontinence and pelvic organ prolapse.  These meshes are composed of polypropylene, a synthetic material that is commonly used inside the human body for many purposes, including  hernia repairs as well as a suture material.   I cannot speak for the provenance of the raw materials used for Boston Scientific meshes, although the issue has apparently been addressed by Boston Scientific as well as the FDA, but I can certainly vouch for the safety and effectiveness of their slings and meshes.  After watching the 60 Minutes piece, one might wrongly conclude that Boston Scientific meshes specifically, and all polypropylene meshes generally, are downright dangerous and should never be used in humans.

Au contraire!  Boston Scientific is a reputable company dedicated to both female and male pelvic health and their mesh products (Obtryx mid-urethral sling for stress urinary incontinence and the Uphold Lite for anterior and apical pelvic organ prolapse) are well-designed and clinically effective. I have implanted these products successfully in hundreds of women with stress incontinence and pelvic organ prolapse over the course of many years and will continue to use them.  Furthermore, I have always found the Boston Scientific “reps” to be knowledgeable, available and helpful and the company always willing to provide ample educational opportunities for physicians.  With respect to meshes used for pelvic reconstructive surgery, polypropylene has been the “gold standard” for many years.  Many clinical publications support the safety and effectiveness of polypropylene pelvic floor meshes and numerous medical societies and regulatory bodies have endorsed the utility of polypropylene pelvic meshes for pelvic floor dysfunction.

Proper Repair of a Dropped Bladder (Cystocele)

Not every cystocele is the same, differing in type, extent, symptoms, and degree of bother. The central type (top image below) is a central weakness of the support tissues of the bladder that can cause a pronounced degree of prolapse. The lateral type (bottom image below) is a detachment of the bladder support from the pelvic sidewalls, usually causing only a modest degree of prolapse. Most women have a combination of these two, a combined central-lateral type.

In my opinion, the classic “plication” repair (sewing together of native tissues)— a.k.a. colporrhaphy—is best suited to a central cystocele in which satisfactory native tissues are present.  However, this will not adequately address a lateral defect cystocele or a combined cystocele. Thus, it is important to determine the type of cystocele in terms of repairing it with native tissues. One of the advantages of a mesh repair is that it addresses all three types of cystocele. Additionally, instead of using native tissue that has already failed in terms of providing adequate structural support, mesh repairs use a strong and durable material to provide support.

Factors influencing me to do a mesh repair over a classic colporrhaphy are the following: poor tissues; risk factors for recurrence including chronic constipation, cough, obesity, and occupations that require manual labor; a relatively young patient who will need a durable repair; and those patients who have already failed a native tissue repair.

In the appropriately selected patient operated on with the proper surgical technique, the results of polypropylene mesh repairs have been extraordinarily gratifying. These procedures pass muster and the “MDSW” test—meaning I would readily encourage my mother, daughter, sister or wife to undergo the procedure if needed. When performed by a skilled pelvic surgeon, the likelihood for cure or vast improvement is great and the likelihood for complications is minimal. Meshes are strong, supple and durable and the procedure itself is relatively simple, minimally-invasive and amenable to outpatient surgery. When patients are seen years after a mesh repair, they are usually extremely satisfied and their pelvic exams typically reveal restored anatomy with remarkable preservation of vaginal length, axis, caliber and depth.

Meshes act as a scaffold for tissue in-growth and ultimately should become fully incorporated by the body. I think of a surgical mesh in a similar way to a backyard chain-link fence that has in-growth of ivy. Meshes examined microscopically years after implantation demonstrate a dense growth of blood vessels and collagen in and around the mesh.

As compared to the classic plication, when a mesh is used for bladder repair, there is rarely any need for trimming the vaginal wall, which makes for a more anatomical repair in terms of vaginal preservation. Another advantage of mesh repairs is that if the patient has a mild-moderate degree of uterine prolapse accompanying the cystocele, the base of the mesh can be anchored to the cervix and thus provide support to the uterus as well as the bladder, potentially avoiding a hysterectomy.

In my opinion, the keys to success are the following: estrogen cream preoperatively in the post-menopausal patient; intravenous and topical antibiotics; a small vaginal incision; good surgical exposure; careful technique making sure the mesh is anchored at the appropriate anatomical sites; trimming the mesh to use the least mesh load possible; avoiding mesh folding, redundancy and tension; and vaginal packing and oral antibiotics post-operatively.

The bottom line is that mesh repairs for pelvic organ prolapse have been revolutionary in terms of the quality and longevity of results—a true game changer. They represent a dramatic evolution in the field of female urology and urological gynecology, offering a vast improvement in comparison to the pre-mesh era. That said, they are not without complications, but the complication rates should be reasonably low under the circumstance of proper patient selection, a skilled and experienced surgeon performing the procedure, excellent surgical technique, utilization of the optimal mesh and patient preparation.

Mesh Integration

Three factors are integral to mesh integration, the process by which the mesh incorporates seamlessly into the body: mesh, patient, and surgeon factors. The goal is for the mesh to fully incorporate into the body so that it can serve its role in providing support to the urethra and/or bladder to cure/improve the stress incontinence and/or cystocele, respectively.

The “gold standard” mesh is large-pored, elastic, monofilament polypropylene. This has been the standard for sling surgery for stress urinary incontinence for over 20 years and for pelvic reconstructions for many years as well. This material is also the standard for mesh hernia repairs and also serves as a hardy suture used for closure of the abdominal wall.

Patient considerations are equally vital.  Risk factors for integration problems include: compromised or poor-quality vaginal tissues; radiated tissues; diabetes; patients on steroids; immune-compromised patients; and patients who use tobacco.

Foremost, a well-trained, experienced pelvic surgeon should be the person doing the mesh implantation. The surgeons most skilled and adept fake newsat this type of surgery are those who have undertaken fellowship training in female pelvic medicine and reconstructive surgery after completion of their urology or gynecology training. It is sensible to check if your surgeon is specialized, and if not, at least has significant clinical experience doing mesh implantation procedures. It is particularly important that the surgeon performing the mesh implant is capable of taking care of any complications that may arise.

The “Mesh-up”

Historically, many of the problems that occurred resulting from mesh implantations were not intrinsic to the mesh itself but were potentially avoidable issues that had to do with surgical technique and/or patient selection. Complications with integration such as mesh exposure—a situation where the mesh is “exposed” in the vagina and is not positioned in the correct surgical plane—can and do occur in a small percentage of patients (even when properly selected and when done by a well-trained pelvic surgeon).  When this situation occurs, it is generally quite manageable, although it will often involve revision surgery if it does not respond to conservative measures.

The crux of the “mesh-up” problem was that a few years ago several of the companies that sold mesh products–in an effort to amplify sales and profits–inappropriately and aggressively promoted their products to physicians who were not trained pelvic surgeons.  They offered “weekend training courses” to general gynecologists, many of whom started implanting pelvic meshes into patients after only a brief training period, often with disastrous results, with many patients sustaining incorporation issues.  This ultimately led to lawsuits and litigation and thereafter several of the mesh companies including Johnson and Johnson Gynecare and American Medical Systems pulled their mesh products off the market.  Fortunately for pelvic surgeons and patients alike, Boston Scientific remained in business, and it is their sling and mesh products that I most commonly implant for female pelvic surgical procedures.

This is not to say that there have not been bad mesh products on the market.  Historically, both the Mentor ObTape and the Tyco IVS sling were poorly designed mesh slings that did not have favorable incorporation features, had horrific results and were ultimately withdrawn from the market.

All of the slings and meshes that remain on the market that are used for pelvic floor surgery in the USA—including the Boston Scientific products–have favorable incorporation features and have been time-tested and have demonstrated their utility. Boston Scientific did not deserve a reaming on 60 Minutes, but I suppose it is irresponsible “spin” that makes for a story and commands advertising dollars.

Tags: Andrew Siegel MD, Boston Scientific, cystocele, dropped bladder, pelvic meshes, pelvic organ prolapse, polypropylene, stress incontinence

This entry was posted on May 18, 2018 at 8:03 AM and is filed under health and wellness. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.