Expert addresses the stigmas associated with vaginal mesh surgery

Vaginal mesh surgery has been in practice for a long time, but it is no stranger to debate in the urology community.

In speaking about this topic, Jerry G. Blaivas, MD, FACS, debunks some of the common stigmas associated with mesh slings. He stresses the importance of both the pros and cons of this procedure as well as communicating those factors to patients who are thinking about getting this surgery to treat their incontinence. Blaivas is a professor of urology in the Icahn School of Medicine at Mount Sinai in New York City, New York.

What are some stigmas associated with vaginal mesh surgery?

Well, I think there are 2 kinds of stigmas. There's the stigma that any patient feels about incontinence, and then there's also the stigma of the operation itself. Historically, patients have always felt stigmatized about incontinence. Women with fistulas, for example, have terrible incontinence and, until effective treatments were developed, they were social outcasts for their entire lives. So, the patients are embarrassed and [a]shamed. They think that people can smell the urine, they sometimes shun social contacts, they are sometimes are isolated and depressed, but to a large extent, that's changed over the last 4 decades. So now, I think most people with incontinence understand that there are lots of other people with incontinence [and] there are lots of treatments for it. There are pads and appliances, and doctors are much more open about it and willing to talk about it, and there are better treatments. So, I think the stigma is still there, but it's much improved over the last 40 years or so.

I'd like to pay tribute to the 2 women who made this happen. One of them is Katherine Jeter [EdD, ET], and the other is Cheryl Gartley. Katherine is a retired enterostomal therapist, and [for] Cheryl, I'm not exactly sure what her background was to get interested in [this topic], but they both, coincidentally, formed [not-for-profit] patient advocacy groups [in 1982]. Katherine founded the National Association for Continence, and Cheryl founded the Simon Foundation for Continence. They raised public awareness tremendously and I think [they emphasized] the whole concept of ‘you’re not alone.’ They educated patients, doctors, and industry. They really got the grassroots involved to destigmatize incontinence as much as possible.

Then, there is the stigma associated with the operation itself – the serious and sometimes lifestyle altering complications arising from mesh surgery, which, in my judgment, occurs in at least 5 - 10% of women and may be much higher than that. These complications have fueled over 100,00 lawsuits against mesh manufacturers in the USA.

How do the stigmas surrounding vaginal mesh surgery impact the management of women with stress urinary incontinence (SUI) or other related conditions?

From the patient’s perspective, the stigma still exists, although it’s much less than previously. I’m sure there are still women and men who are too embarrassed to speak about incontinence and don’t seek treatment. But the positive aspects of “coming out,” and seeking care far outweigh the stigma. I think the overwhelming majority of people who are bothered by incontinence seek treatment and I think there are now many more doctors who are experts at evaluating patients and providing the care. On the other hand, there are many women who seek care, but are scared off from surgery because of the stigmas associated with mesh complications

What would you say is the urologist’s role in destigmatizing vaginal mesh surgery?

The urologist's role is, first and foremost, to provide the patient with a realistic assessment of the risks, benefits and alternative treatments based on the particulars of the individual patient. In my experience, all too often, when it comes to sling surgery, surgeons quote or paraphrase the refrain that slings are safe and effective, a refrain that is embedded in the official guidelines and statements from most of the urologic and gynecologic societies. Well, I think that slings are effective, [but] not as safe as they say. It’s the urologist's obligation to make that clear and to offer the patient the tools (informed consent) that enables them to choose the treatment that is most appropriate for their particular condition.

If patients understand the risks and benefits and choose the most appropriate treatment and if the urologist provides them with realistic expectations, the stigmas of incontinence treatment should fall to an absolute minimum.

Those original stigmas about the surgery were well founded.Going back to the late 1950s and early 1960s, surgeons began to use mesh slings for patients with refractory incontinence, mostly those who had failed multiple operations. These slings were composed of non-absorbable, braided polyester or polypropylene Type III meshes which, even in the hands of highly skilled surgeons caused devastating, refractory complications resulting in “bladder cripples,” and not surprisingly, sling surgeries fell out of favor, hence the stigmata.

Then in the 1980s and 1990s autologous fascial pubovaginal slings were developed. In the mid-nineties, with the introduction of Type 1 polypropylene meshes, which proved to safer than the older versions, synthetics slings were revived and reinvented. Currently, the new generation of polypropylene slings with their disposable kits have become, by far, the most common operations performed in the USA for stress incontinence. Over time, autologous and mesh slings have proven to be of equal efficacy, but the autologous slings are much safer with respect to serious complications. There are still terrible, complications, from these mesh surgeries, but the likelihood of them occurring is much less now than they were back then.

So, autologous slings and synthetic slings are about equally effective. they both have the same success rate, [but] there are 2 huge differences between them. The synthetics slings are much easier to do. They're faster, the recovery is quicker, there are less wound complications [and] there's not a steep learning curve. That accounts for the huge popularity amongst patients and physicians alike. On the other hand, synthetic mesh slings still have a unique, troublesome complication profile that has proven impossible to shake. The most common of these adverse events are chronic pain, mesh erosion, refractory voiding dysfunction and overactive bladder. These complications are exceedingly difficult to treat, are often refractory in nature and may irrevocably alter the patient’s life, a consequence depicted in sobering detail in a study by Hansen et al entitled “Changed Women.”

Of course, autologous slings are subject to other complications, common to all operations for stress incontinence including urethral obstruction and overactive bladder and, in fact, the overall complication rate amongst the 2 cancer slings are comparable except for the fact that erosions, chronic pain and dyspareunia are practically nonexistent after autologous slings.

I mentioned, above, that at least 5 to 10% of patients undergoing mesh slings develop life style altering complications. In my judgment, the vast majority of both doctors and patients don’t fully understand the impact of these numbers. Five percent is one in 20 patients whose lives may be irrevocably worsened by a 20-minute outpatient procedure. That’s not rare, that’s not safe and, to me, that’s sobering.

There is also a tremendous positive side to the vaginal mesh story. I started with the complications, simply because, in my judgment, they are so terribly under appreciated by doctors and patients alike. The positive side is not only that the vaginal mesh is a fast, quick procedure that works well in a lot of patients, but more to the point, it's opened up incontinence care to many more patients. Back in the 1980s when this stuff was all starting, a tiny fraction of people who suffered from incontinence went on to surgery, compared to now, where there are so many more capable surgeons. So, we offer this to many more patients whose lives are improved. But, of course, that opens up the possibility of some awful complications to many others. That’s a dilemma.

My own personal opinion is that the autologous slings, are just as effective as synthetic mesh slings and much safer. But there's an 'if,' and that 'if' is if the surgeon is adequately trained and comfortable doing an autologous sling. I'm sorry to say that the current generation is not comfortable with autologous slings; few training programs even teach them. That’s another dilemma.

As the field continues to advance, what innovations in treatment for SUI or other related conditions do you foresee in the near future?

I don't really foresee anything in the near future. Prevention would be nice, but I don't think there are very many things an individual person can do to prevent incontinence. Pelvic floor muscle training, exercising and, weight reduction are good things to do and they promote overall health but it is unclear to me whether they can prevent incontinence. Good prenatal and obstetric care certainly is important and can offer some protection. And then, I think there's the possibility of genetic engineering in the future to help prevent this stuff, but that’s a theoretic prospect that will have to wait in a long line behind more compelling problems like curing cancer, diabetes, and hypertension.

Better synthetic slings? I'm not terribly hopeful, but it’s worth a try. The main problem with synthetic slings, in my estimation, is that they incite chronic inflammation in just about everybody. So, it’s an immunological problem. If the body can keep it at bay, then maybe sling complications will be less, but maybe not. Another possibility is better urethral bulking procedures, and that's something that may be in the future. Whether or not stem cell therapy, which some people have tried, emerges is something that's also a possibility. But, don’t forget that stress incontinence is just one of a host of problems that ensue because of the frailty of pelvic floor support, vaginal atrophy and the ravages of gravity and aging.

So, I'll leave it to people smarter than me to predict and forage the future. The one thing that I think is too bad, at least for the immediate future, is that there aren't enough surgeons skilled in natural tissue repairs, because I think the autologous sling, in the hands of a skilled surgeon. is a very effective operation with few significant long-term complications>

Is there anything else you feel our audience should know about this topic?

Firstly, sling surgery, whether it’s using natural tissue or synthetics, is effective in the majority of patients. However, effective is not synonymous with cure; most patients are significantly improved and pleased with the results, but rigorous studies have shown that about one third to one half of patients still have some degree of incontinence.

Secondly, there is a paucity of long-term studies; the majority of patients are going to be so improved that they're pleased that they had the surgery. How long it lasts [is something] we don't know. I'm comfortable that for most people it lasts 5 to 10 years, but after that the follow up really falls off. In my own anecdotal experience, after successful surgery most people are either content with, or resigned to, whatever incontinence recurs and most don’t see retreatment. But remember, anecdotes are not science.