In Defense of Mesh for Prolapse and Incontinence (*with lots of caveats)
By Aldene Zeno, MD
Chances are you may have seen the attorney commercials: “Are you suffering from vaginal mesh?” This implant has come under fire over the last decade due to complications such as mesh migrating into other pelvic organs, chronic pelvic pain, infection…the list goes on. And yet, some vaginal mesh remains on the market, while others are no longer commercially available. With multiple messaging around vaginal mesh, it can be confusing. Is there any safe application for vaginal mesh these days?
Not All Mesh are Created Equal
Before I go into the safety profile for different types of mesh used in pelvic surgery, it’s important to know that there are 3 main different types.
1) Slings placed vaginal for urinary incontinence: These were originally described in this 1995 article and have been FDA-approved since 1998. Over the last 20+ years, clinical studies have proven that risks of complication are low. Reoperation for sling complications is low across multiple, large studies at 3–5%. Life-threatening or major injuries are very unlikely (less than 1%). It is the most common surgery used to treat stress urinary incontinence in the United States, and for good reason. I describe this more below.
2) Abdominally-placed mesh for pelvic organ prolapse: Today, these are mostly used in minimally invasive surgeries such as laparoscopy or with robot assistance. Traditionally, surgeons would use a mesh-like material and cut it into a shape, often a “Y,” to help pull up a prolapsed vagina. Today, the best-studied and safest material we know of is polypropylene mesh, and most surgeons use a device that is pre-fashioned from one of the major medical companies. It is the most effective procedure to treat advanced prolapse, with a lower risk of prolapse coming back compared to surgeries without mesh. Gynecologic surgeons have used abdominal mesh to treat prolapse since the 1970s.
3) Vaginally-placed mesh for pelvic organ prolapse: In 2019, the FDA ordered companies to stop making these products, as detailed here. These products became FDA approved in 2002, and in the relatively short time that they were on the market, complications were reported in up to 25%. The benefit of these devices are only demonstrated in a small portion of patients, mostly people who have failed other surgeries and who have certain types of prolapse. The surgeries are sometimes still performed in these special situations, though only by skilled surgeons and with lots of counseling about the risks/benefits given that the devices are no longer on the market.
Why did the medical industry fail so miserably with mesh for prolapse and incontinence?
The first vaginal mesh became FDA-approved through what’s known as a 510k process, detailed here. Basically, it underwent less rigorous study than other medical devices, predicated on an understanding that it was similar to existing medical devices (i.e. hernia mesh). After only a few years on the market, the first FDA-approved vaginal mesh was pulled from the market due to complications, which is the Protegen sling for incontinence.
It’s honestly hard to find an unbiased description of why the Protogen sling was such a failure given all the hype around mesh litigation. When I tried to Google info about the Protogen materials and history, most of the websites that came up were for lawyers. They clearly have a stake in depicting the sling as irresponsibly made, performed by money-grubbing doctors, etc.
What I know from talking to colleagues who lived through this is that many surgeons took up the Protogen sling and started performing them without having sufficient training. As with any new medical procedure, there is a learning curve. Urogynecology now is a 3 year fellowship training after 4 years of gynecology residency. In the late 1990s when Protegen came to market, urogynecology did not exist as a field. Unfortunately, because of the truncated approval process, we did not have the information ahead of time to anticipate the complications before this first sling came to market.
Another player that is blamed are the medical device companies. Hundreds of millions of dollars have been paid by Johnson and Johnson, Boston Scientific, and other major companies, mostly for deceptive marketing practices that under-reported mesh complications. I think this is an important point for patients considering mesh litigation, because these were large, class-action lawsuits against the companies, and not against doctors. I say this not in defense of my profession (ok, maybe a little bit), but patients expecting a big payout from their doctor because of a mesh complication may be mislead by lawyers trying to make money off of someone’s misfortune. Regardless, many of my colleagues who lived through the major mesh upheavals of the late 90s and early 2000s confirm that medical device companies were minimizing the time and expertise needed to place vaginal mesh in order to have surgeons take up these new procedures.
When vaginal mesh prolapse kits came to the market, they were somewhat deceptive in their simplicity. As I mentioned, abdominally-placed mesh for prolapse has been around since at least the 1970s. However, it is a very complex procedure requiring great skill and repetition. Many surgeons were sold on the idea of vaginally-placed mesh being a short procedure with quick recovery and good outcomes. However, none of that had been proven, and now we know that for the most part it’s not true.
Vaginal Mesh, Bad. Abdominal and Sling Mesh, Good. Or is it?
First, as I mentioned above, slings for incontinence and abdominally-placed mesh for prolapse are the most effective procedures for their respective conditions that we have to date. Their safety profiles are fairly consistent across multiple studies, and with the advent of urogynecology as a board-certified subspecialty in 2011, the people doing these procedures are better trained than ever. The complications are low, and most do not require repeat surgery. Urinary incontinence and pelvic organ prolapse are common, debilitating conditions, and women need effective treatment options. So why may these surgeries not be for everyone?
Any surgery with mesh incurs risks, even if the risks are low. As a fellowship-trained urogynecology surgeon, I have performed hundreds of surgeries with mesh. However, I believe every woman should know that there are mesh-free alternatives, as well as non-surgical options, and these may also be effective. Having taken out mesh from several women, I’ve seen how mesh complications can be devastating. The decision to proceed with surgery with mesh requires much thought, informed counseling, and shared decision making between a skilled surgeon and the patient.
With regards to vaginally-placed mesh for prolapse, there are only limited uses. As I mentioned above, these commercially-available kits have been pulled from the market due to reports of high complications and insufficient evidence to demonstrate their benefit. There is limited evidence for use in women with recurrent prolapse, especially in what we call the anterior compartment or the area between the bladder and vagina. Because there are no commercially available products, surgeons have to have the experience and expertise to modify existing materials that are indicated for other procedures (example, mesh used for abdominal hernias, other grafts both synthetic and biologic).
Summary: mesh may be for you, but maybe not
As I stated above, board-specialization came about in 2011 for surgeons treating prolapse and incontinence. This specialty is known as female pelvic medicine and reconstructive surgery (FPMRS) or urogynecology. Anyone performing surgery with mesh should have specialized training in these procedures as described by the FDA. This doesn’t necessarily mean that your surgeon has to be fellowship-trained if they’re doing these procedures. However, an FPMRS surgeon is guaranteed to have undergone extra training for this. We typically have done many more, studied them more, and can offer a more balanced approach to these and other treatments compared to non-fellowship trained counterparts.
Choosing the right surgeon can be a daunting task. Websites like voicesforpfd.org can help find a surgeon near you that is qualified to care for your pelvic disorder.
