WHAT IS STRESS URINARY INCONTINENCE (SUI)?
Stress incontinence is the unintentional leaking of urine upon exertion. With stress incontinence, instability exists in the pelvic floor muscles, more specifically the external urethral sphincter. When there is an increase in abdominal pressure the sphincter contracts to remain closed. If the intra-abdominal pressure is greater than the pressure produced by the contraction, urine can leak. If you are leaking a few drops of urine when coughing or sneezing this is a sign of stress incontinence. Stress incontinence can also happen when participating in high impact sports or lifting heavy weights. For example; running, dancing, horse riding, trampolining, gymnastics, cross-fit and weight lifting are all activities that can highlight stress incontinence symptoms. If you are leaking with less forceful activities, like standing up, walking or bending over, this indicates your incontinence is more severe.
HOW CAN I KNOW THE SEVERITY OF MY SUI?
With stress incontinence, you can leak anything from a few drops to soaking through your clothing down to the floor. Studies have shown the Sandvik test to be a good measure of incontinence severity. You can use the Sandvik test to determine your level of incontinence. This index is sometimes used by urologists to evaluate incontinence. Minimum score 0, maximum score 12. The higher the score, the higher the degree of incontinence.
MY SUI IS SEVERE, DOES THIS MEAN THAT PELVIC FLOOR MUSCLE TRAINING (PFMT) WON’T WORK?
No, the severity of your stress incontinence is not directly connected to the effectiveness of pelvic floor muscle training (PFMT). You should have a pelvic floor muscle training program that is tailored to you based on the condition of your pelvic floor muscles. Studies show that women who have weaker pelvic floor muscles to begin with have the greatest percentage improvement in symptoms from PFMT. Consistency is key. Your pelvic floor physiotherapist can help you to set goals that are achievable.
WHAT IS PELVIC FLOOR MUSCLE TRAINING (PFMT)?
Traditional PFMT involves exercising pelvic floor muscles to restore muscle strength and function. These exercises are often called Kegels – named after Dr. Arnold Kegel who first identified the importance of exercising the pelvic floor to maintain continence. It is important to learn how to perform Kegels properly.
I HEARD KEGELS DON’T WORK, IS THAT TRUE?
No, SUI is typically due to weakness in the pelvic floor muscles. If your pelvic floor muscles are weak then Kegels should help to improve your strength and tone. If you are suffering from non-relaxing pelvic floor dysfunction (NR-PFD), you should avoid doing Kegels. Non-relaxing pelvic floor is a condition where the muscles are excessively tense (hypertonic). Those with NR-PFD are unlikely to suffer from SUI.
IS THERE ANYTHING ELSE I CAN DO COMBINED WITH MY PFMT?
Yes, PFMT is localised to your pelvic floor muscles and will help with creating localised strength, however, your pelvic floor muscles do not work in isolation. Taking a whole body, whole life, whole mind approach will improve your chance of success. You should note that age, race and general health all have an impact on stress incontinence. Age and race cannot be controlled. Some health conditions like asthma, diabetes, hypertension and fibroids can also increase your risk. Try to focus on the things you can change rather than the things you can’t.
Your pelvic floor has relationships with surrounding muscles. In recent years, Biomechanists, structural integrators, movement therapists and yoga teachers have been expanding pelvic floor rehabilitation programs to include other key muscle groups that have a direct relationship with the pelvic floor (such as the diaphragm, core and gluteus muscles). By working on a range of functional movements, in combination with Kegels, the pelvic floor can become more stable. This should allow you to carry out a broad range of dynamic movements without leakage (e.g.: running, jumping etc.)
Your posture and alignment can impact the stability of your pelvic floor and should be assessed as part of your rehabilitation. Your fascia (connective tissue) holds your posture. Advancements in fascial research, led in part by Tom Myers who developed Anatomy Trains, has brought about a much clearer understanding on how load is distributed through the body’s network of fascia. When looking at the connective tissue in the pelvic floor, you will see an elaborate network that supports the uterus. You will also see that the urethra is supported by endopelvic fascia which is connected laterally to the vaginal wall. Viewing muscles in isolation means you are only looking at part of the puzzle. Working with a structural integrator or myofascial release therapist is a good addition to your rehabilitation.
Did you know that for every additional unit increase in your BMI, your risk of developing incontinence increases by 1%? Obese people have double the risk of developing incontinence. It’s not just the risk of incontinence that increases with wight gain, the severity also increases. Obese people are three times more likely to suffer severe incontinence than normal weight people. Lowering weight typically also lowers the severity. If your BMI is over 25, lowering your weight will help to decrease your intra-abdominal pressure which will have a positive effect on your incontinence. Diet plays a big role in weight loss/gain. It can be helpful to work with a nutritionist to help bring your weight back into the healthy BMI range. Movement also helps with keeping weight in check. Go walking with a friend or join a fitness class to help keep things in balance. As well as having a positive effect on your pelvic health, this should also improve your overall health.
There is a psychological aspect to stress incontinence. As incontinence is a taboo subject, finding yourself suffering with this condition could leave you feeling isolated and depressed/anxious. There are many options available from speaking to a therapist to meditation. It is important for you to realise that you are not alone, which is why we have established the community on this website.
A randomised study that evaluated the effects of PFMT for SUI in two groups, one that performed PFMT at home, and the other that performed PFMT at home combined with a group training session once per week, showed that the group who participated in group training showed significant improvement over the home trained group. In the same way that digital health communities help to motivate and support individuals to achieve goals, meeting face to face with others can also help in achieving your goals. Physically meeting with others on a regular bases empowers you to stay accountable thus increasing your chances of success. There are many classes that are geared towards pelvic health. If your pelvic health physiotherapist does not offer a weekly group session, try to find a pilates, yoga or hypopressive class focusing specifically on pelvic floor training.
Did you know that smoking more than 20 cigarettes per day increases your risk of developing incontinence? The smokers cough is believed to be a contributing factor. A study into the functional anatomy of the female pelvic floor with stress incontinence found that the intra-abdominal pressure from a sudden hard cough results in pressure on the pelvic floor requiring it to stretch by 1cm. This may not sound like much, but try to lift your pelvic floor by 1cm – not so easy, right? Each cough is like a little punch. If you keep punching your pelvic floor, you will weaken it.
If you have a sedentary lifestyle, increasing your level of activity can help to reduce your level of incontinence. A Norwegian study found that “women who participated in low intensity activities for one hour or more per week had less incontinence than those who did not”.
MEASURING YOUR PROGRESS
You should always start by establishing your baseline before you begin training as this allows you to properly assess your progress. There are a number of different ways in which to measure progress. You can retake the Sandvik test every few months to reassess your incontinence and monitor your body’s response to the training. You can also purchase a biofeedback device, which can also be used as part of your training. If you go to see a pelvic floor PT or urologist, they can also perform biofeedback testing as well as ultrasound to directly see the activation of your pelvic floor. Urodynamic testing is often preformed by a urologist to make an assessment of your bladder function.
There are numerous products available to manage the symptoms of incontinence from pads to pessaries. There are also devices to aide pelvic floor muscle training ranging from weights to electronic stimulation devices. Reviews of these products will be covered on our YouTube channel. If there is a specific product that you would like to see reviewed, just contact us and we will review. The images below link to the products on in your local amazon store.*
* I am an affiliate of amazon, iTunes and other affiliate services and may receive a small commission should you purchase through links on TheFlowerEmpowered.com
CONSERVATIVE TREATMENTS HAVE NOT WORKED FOR ME, WHAT NEXT?
You should give conservative stress incontinence treatments time to take effect. The more severe your stress incontinence, the longer it may take. A “can do” attitude really helps. It took me one and a half years to go from severe SUI to very mild SUI following removal of my mesh sling and an additional 8 to 9 months to achieve full continence. It sounds like a really long time, but when I look back, it passed in the blink of an eye. Consistency was key to my rehabilitation. I recommend you give yourself at least one year of consistent steady training before considering the more invasive options of bulking agents or surgery. Your pelvic floor physical therapist can refer you to a urogynecologist to explore further treatments if the conservative treatments fail.
WHAT OTHER TREATMENT OPTIONS DO I HAVE?
There are a number of additional treatments that can be offered. Some of those listed below (namely pessaries and urethral blocking) are for management of the condition rather than cure. All treatments that involve putting something into the body, including bulking agents, laser treatment and surgery, carry more risks than the conservative options. These adverse effects can include urinary tract infections, worsening incontinence symptoms, pain and discharge. We will review the issues associated with surgery in the next section.
Pessaries are often used to treat pelvic organ prolapse but can also be used if you are suffering from urinary incontinence. When it comes to stress incontinence, you can think of a pessary as being similar to a tampon, in fact, if you are suffering from mild stress incontinence when running, wearing a tampon could provide sufficient support to your urethra to reduce leakage. Of course, it would make more sense to use an actual pessary than a tampon! You can use a product like Contrelle Activgard which you insert into the vagina similar to inserting a tampon. In some countries, this is available on prescription from your doctor. Alternatively, you can use a ring pessary which is a plastic device somewhat like a contraceptive diaphragm. You insert the ring pessary with two fingers placing it snuggly around the neck of your womb. This type of pessary is more typical to treat pelvic organ prolapse but it does offer extra support to the neck of the bladder thus helping to prevent stress incontinence.
There are a number of products on the market to block the urethra thus preventing the leaking of urine. These devices use either suction or adhesive to cover the entrance to the urethra. Think of it like putting a plaster over the urethral opening thus blocking the urine. Single use studies for all devices have shown significant improvements in pad tests.
Medication is not traditionally given to treat SUI. However, in the past decade, European doctors have have prescribed Duloxetine which attempts to increase the activity of the nerve that stimulates your urethral sphincter. This improves the function of the urethral sphincter and will reduce the episodes of stress incontinence. As with all medicines, there are risks of side-effects. A 2017 study stated that “Although duloxetine is effective for stress urinary incontinence in women, the rates of associated harm were high when individual patient data were analyzed, and the harms outweighed the benefits”. Your doctor will need to decide if this medicine is right for you.
If your oestrogen levels are low, your doctor may also prescribe oestrogen creams or tablets that can be inserted into the vagina, although this is unlikely have any effect on your stress incontinence.
Everyone is familiar with the trout pout, and most likely, also familiar with the injections to bulk the lips in order to exaggerate the trout pout. A similar treatment is available to add bulk to the tissues surrounding the urethra. In the same way that the lip fillers break down over time returning the lips to their normal state, the bulking agents will also break down over time meaning that a repeat treatment will likely be required at some point.
Laser treatments have been used for many years to treat skin conditions. There are a number of laser treatments being offered to treat stress urinary incontinence. Originally, laser vaginal treatment was used in plastic surgery with terms like “rejuvenation” and “vaginal tightening” being used to market the treatments. This caused some medical professionals to raise concerns as to whether these procedures were ethical. A 2015 study showed some promising, with 77% of patients with SUI showing improvement at one year follow-up. Side effects have not been fully documented and it is not yet clear what long terms results are. More studies needed.
The most common treatment being administered is surgery. In fact, the rate of surgery for stress urinary incontinence has increased three fold since mesh devices were brought onto the market in 1996. It is typically “surgeons choice” as to what surgery is preformed and most opt for the “minimally invasive” mesh surgery. The surgery typically takes 15 to 20 minutes and is a day case (meaning you can go home on the same day as surgery). Mesh devices to treat stress urinary incontinence are permanent implants that are considered to be the “gold standard”. In many cases surgery is offered as the first line of treatment for stress urinary incontinence. One dutch study found that 36% of patients who had been given mesh surgery for SUI did not need it! The author of the study also commented that “Minimally invasive does not stand for quick, easy, and superb outcomes”.
I’VE BEEN TOLD I NEED SURGERY, WHAT SHOULD I KNOW BEFOREHAND?
If you have not seen a pelvic health physical therapist and tried conservative treatments for at least one year, you should get a second opinion. There are a number of surgical options available and the options presented to you will be dependent on your surgeon’s experience and preferences. All surgeries carry risks, even those considered to be “minimally invasive”. Carefully consider your options and make sure surgery only carried out a last resort.
SET APPROPRIATE EXPECTATIONS
It is important to have realistic expectations if you are going for surgery, and to ensure that your surgeon is aware of those expectations. Successful surgery according to you may not be the same as successful surgery according to your surgeon. Studies into the surgical treatment of SUI typically measure success either as object cure rate, subjective cure rate or a combination of the two. Within a single study, the objective and subjective cure rates can vary greatly. A good example of this is this study from 2012 comparing mid-urethral slings. For TVT mesh sling, the subjective cure rate was 79,8% whereas the objective cure rate was 95%. For TVT-O mesh sling, the objective cure rate was 95% but the subjective cure rate was 54,8%!! How is this possible?
Let’s use a simple example: A patient has surgery for SUI where a mesh device is implanted. Following surgery, the symptoms of stress incontinence have disappeared, therefore she is objectively cured. However, she now suffers pain during intercourse and is no longer able to have sex. Although her incontinence has been cured, she views this surgery as unsuccessful due to the impact on her quality of life.
WHAT ARE THE SURGICAL OPTIONS AVAILABLE FOR SUI?
There are three main surgeries offered to treat SUI, two of which offer to support the urethra and one which involves the use of an artificial urethral sphincter. Artificial sphincters are rarely used. The two remaining types of surgeries are retropubic suspension, which involves supporting the urethra with sutures, and sling surgery, which involves supporting the urethra with a graft. Grafts are either biological or synthetic. Biological grafts can be autologous (fascia/connective tissue taken from your own body), Allograft (fascia/connective tissue taken from a cadaver) or Xenograft (animal derived collagen tissues typically from a cow or pig).
Synthetic meshes are typically made with polypropylene (also called prolene) which is a type of plastic that is used for packaging and carpet backing. When doctors talk about mesh slings, they can call them by many names – tape, rippon, elastic band etc. They can also refer to them as mid-urethral slings (MUS). These MUS’s fall into three categories – TVT, TVT-O and mini-slings (also known as single incision slings – SIS). Regardless of what they are called, they are made from knitted plastic and often have sharp edges.
Retropubic Suspension (Urethropexy) is a procedure where sutures are used to improve the positioning of the urethra to prevent stress incontinence. The surgery treats stress incontinence by lifting the neck of the bladder using sutures. It was first performed in 1962 by Dr. John Burch. There have been several modifications to the technique over the years such as the Marshall-Marchetti-Krantz (MMK). These procedures are performed either as open or keyhole (laparoscopic) surgery. The main difference between the Burch and MMK is the placement of sutures on the pubic side, with Burch sutures are attached to Coopers Ligament. With MMK sutures are attached to the periosteum of the pubic symphysis. You can see an example of these procedures in the images below.
The surgery is performed by making a small incision in your lower abdomen, just above your pubic bone, and placing the sutures. There have been many long term studies into these procedures and success of the Burch procedure is reported to be 90% with 5 to 10 year follow-up and 69% with 10 to 20 year follow-up. The MMK on the other hand has shown lower-success long term and is subsequently not recommended by NICE (National Institute of Health and Care Excellence). Retropubic suspension is considered to be the gold standard for stress incontinence when there is urethral hyper-mobility.
Biological slings were the first ever slings used to treat SUI back in 1907 when Giordiano used the gracilis (a muscle from the inner thigh) to support the bladder neck. Over subsequent years, other muscles were used until eventually, it was realised that muscles were not ideal graft material due to difficulty with maintaining good blood and nerve supply. The focus turned to using fascia, harvested either from the rectus abdominis (lower abs) or the fascia lata (large band of fascia down the outside of leg). The first major study to confirm that autologous facial slings were safe and effective was in 1978 by McGuire et al.
The native sling, also known as Autologous Pubovaginal Sling (PVS) is attached to the rectus fascia above the pubic bone and runs under the urethra providing additional support. Surgery itself involves taking the graft of the connective tissue just below your abs or alternatively taking a graft from your Fascia Lata which runs down the outside of your thigh. The graft is soaked in an antibiotic solution before implantation. You will have an incision in your lower abdomen just above the pubic bone and one just inside the vagina. Surgery should last about an hour and has a recovery time around six weeks. With this type of surgery, you can expect to be in hospital overnight. According to the British Association of Urological Surgeons (BAUS), success rates for PVS are the same as with mid-urethral sling (mesh) procedures.
Allograft slings (from cadaver) and xenograft slings (from an animal) were introduced around the same time as synthetic mesh, however, they didn’t receive the same level of uptake. A study in 2014 found that the costs of repair with synthetic mesh were roughly a quarter of that of biologic mesh. Mesh manufacturers make payments to doctors, hospitals and medical societies that make it even more profitable to use synthetic mesh. Some of the information on payments is now available on dollars for docs and on the open payments data websites.
Mid-urethral synthetic slings have been in use since the mid 90’s. The TVT (Trans-Vaginal Tape) is a retropubic mesh sling. It can be implanted “bottom up” or “top down”. For top down, it is implanted by first making three small incisions, two just above the pubic bone on the left and right side, and one inside the vagina in front of the urethra. The sling is attached to two large needles (known as trochars). The needles are blindly inserted into the vagina and guided past the bladder, blood vessels and nerves, eventually emerging through the small holes above the pubic bone.The blind insertion increases the risk of bladder perforation.The tape lies flat against the urethra and is checked to ensure there is no tension. For this reason, it is also known as “tension free vaginal tape”. The incisions are then closed.
Bottom-up implantation involves the same incisions but the needles are blindly fed through the hole in the vagina finally exiting in the incisions above the pubic bone. In some cases, a small camera may be used to help guide the needles. Bottom-up implantation is the preferred route with some studies suggesting a lower number of bladder perforations with this approach than with a top-down approach.
There are several manufactures of these mesh slings, the main ones being; J&J Ethicon, Boston Scientific, American Medical Systems, Bard and Coloplast.
The TVT-O (Trans-Vaginal Tape – obturator) and TOT (Trans obturator tape) involve placing a mesh sling in the space between the left and right obturator foramen. TVT-O is implanted inside-out with TOT is implanted outside-in.
For TVT-O, an incision is made inside the vagina in front of the urethra. The sling is attached to two large needles (known as trochars). With the inside-out approach, the first needle is inserted into the vagina and guided past muscles, blood vessels and nerves until the fascia at the obturator membrane is perforated. The curved needle is then rotated towards a small mark the surgeon has made on the inside of the patients leg close to the groin. The needle is pushed through the obturator externus muscle, two of the adductor muscles (Magnus & Brevis) and the gracilis muscle before coming through the skin. This is repeated on the other side.
For TOT with the outside-in approach, two incisions are made on the inside of the legs close to the groin and one in the front wall of the vagina. The needle is fed in through the groin on one side, going through the same muscles and past the nerves, blood vessels and connective tissue as with the inside out approach. once the needle makes it to the hole in the vaginal wall, the needle is then guided up through the tissues to come out at the groin incision on the opposite side.
With both approaches, the tape lies flat against the urethra and is checked to ensure there is no tension. The incisions are closed following implantation. Most studies show little difference between efficacy with the two different approaches. As well as mesh erosion, infection and vaginal pain, patients with this type of mesh sling often suffer from leg pain and can have difficulty walking.
There are several manufactures of these mesh slings, the main ones being; J&J Ethicon, Boston Scientific, American Medical Systems, Bard and Coloplast.
The Single Incision Sling (SIS) also know as the mini-sling is a TVT-O/TOT type mesh sling, however, unlike the TVT-O/TOT, the mini-sling attaches to the obturator membrane. This type of sling requires only a single incision in the vagina beneath the urethra. The first of these devices to be introduced to the market was the TVT-Secur (also known as the TVT-S). That device is no-longer on the market due to the sheer volume of issues it created with some studies concluding it was inferior to TVT and TVT-O. Other mini-slings and single incision slings (SIS) are still on the market but cannot be viewed as safe as none have been through proper testing, instead being given approvals based on predecessors, the most studied of which is the TVT-Secur.
Like the TOT, the SIS mini-sling application needle is inserted through an incision in the vagina just behind the urethra. The needle is guided past muscles, blood vessels and nerves. Depending on the specific sling (there are multiple brands), it will either be guided to the obturator muscle or into the obturator membrane. The mesh is placed flat against the urethra with no tension. There are no additional incisions required with this surgery. Mini-slings and SIS devices need some form of adhesion to ensure they attach and stay in place. Some have an adhesive surface, while others have anchors or barbs that have some abrasion allowing them to grip the muscle or connective tissue to which they will attach.
The advice from the UK’s National Institute for Health and Care Excellence (NICE) is that this procedure should only be used for research where the patient has given full consent. If you opt for this type of surgery, you must be aware that you are effectively a guinea-pig!
There are several manufactures of these slings, the main ones being; J&J Ethicon, Boston Scientific, American Medical Systems, Bard and Coloplast.
MY SURGEON WANTS TO USE MESH, WHAT DO I NEED TO KNOW?
A report into corruption in healthcare by BMJ in 2016 showed that corruption is rife in the global healthcare industry, finding that “people, companies, and groups involved in healthcare were placing their private self interests over wider public health goals”. Unfortunately, synthetic mesh to treat SUI, pelvic organ prolapse and hernia is manufactured and sold for profit. Enormous controversy exists surrounding mesh, the latest of which is a 60 minutes documentary which uncovered serious corruption at one of the largest mesh manufacturers, Boston Scientific. It’s not just a US problem, similar documentaries have aired from Sky News in UK, W5 in Canada and ABC News in Australia. Similar mesh is used for hernia operations which is also causing serious health issues according to this BBC documentary released in 2017.
Most studies into mesh are sponsored by the manufacturers which is an obvious conflict of interest. Manufacturers of the mesh devices contribute to teaching schools and in many cases make contributions to individual doctors. Many surgeons, particularly those who graduated since the late 90’s have little to no experience in the traditional SUI surgeries having been trained only with mesh products. Taking mesh away from these young doctors threatens their livelihood which explains why many are so outspoken in favor of mesh. If you are based in USA, you can check the payments your surgeon has received from mesh manufacturers on Dollars for Docs or Open Payments Data.
A typical mesh operation takes 20 minutes. Traditional surgeries to treat SUI takes about one hour. This means a surgeon will see less patients if using traditional treatments, which equals less money – again threatening the livelihood of the surgeon.
Many “not-for-profit” societies and groups receive large payouts and sponsorships from mesh manufacturers. In many cases these societies are responsible for guiding governments on the safety of the products and procedures. Patient support groups also receive donations to push the mesh agenda. The level of corruption is just mind-blowing! A new documentary, The Bleeding Edge, airing on Netflix in July (2018) will attempt to uncover some of this corruption. You can find out more about The Bleeding Edge on Facebook.
This study from 2015 explores the lifecycle of TVT-Secur (J&J Ethicon). TVT-Secur was one of the first mid-urethral single incision slings (SIS) to come on the market. The lifecycle of this device is a great example of a product being pushed out and adopted by the medical profession without testing, and subsequently causing a great deal of harm to many women unnecessarily.
All of the above makes it hard to trust those who should have the patients best interest at heart. We will attempt to weed through the available information presenting the case for mesh as it stands today.
To mesh or not to mesh, that is the question...
UNDERSTANDING THE RISKS
There are standard terms for defining the frequency of adverse events for medical devices. They help to equate the risk of adverse side effect to actual people. For example, if side effects are “very common”, that means that for every ten women implanted with that device, one women is likely to suffer adverse effects. The standard is detailed in the table below:
|Term||Numerical rate||Percentage rate|
|Very common||More than 1 in 10||10% or higher|
|Common||1 in 10 – 1 in 100||10% – 1%|
|Uncommon||1 in 100 to 1 in 1000||0.1% to 1%|
|Rare||1 in 1000 to 1 in 10,000||0.01% to 0.1%|
|Very rare||Less than 1 in 10,000||Less than 0,01%|
If we look at the FDA’s statement on vaginal mesh, which was released in 2011 and so is out of date, we can see that 2% of women will suffer mesh erosion. That indicates that one in 50 women will have the issue. When the FDA issued this information in 2011, along with their warnings regarding mesh for Pelvic Organ Prolapse, they stated that “The FDA continues to evaluate the effects of using surgical mesh to repair SUI and will communicate these findings at a later date”. The result of this evaluation has yet to be released.
Meanwhile, in September 2017, a new study was released and reported to be the largest ever into complications following vaginal mesh to treat SUI. This was an 8 year study of 92,246 women. The conclusion was that 9,8% of all women undergoing mesh surgery to treat SUI are likely to suffer complications between 30 days to 5 years after initial insertion. That is almost one in ten women suffering adverse effects from mesh. This is unacceptably high.
HAVE THERE BEEN LONG TERM STUDIES INTO MESH SLINGS FOR SUI?
The longest follow-up for mesh implantation is a multi-centre Scandinavian study with follow-up over 17 years. The study began with a small sample of just 90 women, which for Scandinavia should demonstrate statistical significance (assuming 10% margin of error with 95% confidence level). The conclusion of the study was that “The TVT operation is durable for 17 years, with a high satisfaction rate and no serious long-term tape-induced adverse effects”. Sounds great right?
What happens if look beyond the conclusion to the actual data? We find that only 55 of the 90 in the study group were available for the 17 year analysis (61%). Of these 55 women, 12% reported worsening symptoms or no change compared to pre-surgery conditions. Of the 55, only 46 could present for physical examination. One of these ladies was found to have mesh erosion on physical exam, thats 2% of the group that made it for physical exam. On reading further, we find that two of the authors admit conflicts of interest.
CONTROVERSY AROUND POLYPROPYLENE
All mesh products are made with a type of plastic called Polypropylene, sometimes referred to as Prolene. This is the same material used to make plastic packaging, carpet backing, woven bags and synthetic ropes. In the recent 60 minutes documentary, plastics expert Duane Priddy explained that polypropylene is not suitable for permanent implantation in the human body. Polypropylene mesh devices typically have antioxidant additives to prevent them from breaking down. These antioxidants break down over time, and once dissipated, oxygen will begin to break up the polypropylene. Chevron Phillips, the supplier of the polypropylene used by many of the mesh manufacturers, issued a warning in 2004 explaining that it should not be used for permanent implantation in the human body, and yet it continued to be used. Boston Scientific refused to be interviewed on the documentary but did issue a statement in response denying all allegations.
HOW DO MESH SLINGS COMPARE WITH AUTOLOGOUS FASCIA SLINGS?
There have been many studies comparing the use of synthetic slings to fascia slings. We have extrapolated the results of three of the studies that do not show conflicts of interest:
A 2004 study found that Synthetic slings are 15 times more likely to extrude into the urethra and 14 times more likely to erode into the vagina compared to non-synthetic slings.
A 10 year multi-centre randomised controlled trial comparing slings (TVT mesh, Xenograft and Autologious fascial) concluded that “there is not enough evidence to suggest a difference in long-term success rates between AFS and TVT. However, there is some evidence that ‘dry’ rates for AFS may be more durable than TVT.”
A 2016 study exploring existing studies into Autologous Pubovaginal slings (AFS) concluded that “autologous PVS is an effective and safe option for surgical treatment of primary and secondary SUI. It can be safely performed with a low morbidity rate and a negligible erosion risk in comparison to synthetic slings.” and suggested that clinicians receive training in both procedures.
HOW CAN I DECIDE IF MESH IS RIGHT FOR ME?
All mesh implants are permanent and adverse events are common. Adverse events include:
- difficulty urinating
- de novo urgency (new incontinence)
- frequent urinary tract infections
- mesh erosion into the urethra or vagina
- mesh erosion into the bladder
- irritation, inflammation and infection
- painful intercourse
- pain in the hips and legs
- mobility issues (some women require wheelchair)
Mesh is implanted to replace damaged fascia (your body’s connective tissue). It is expected that scar tissue will form around the mesh thus bringing bulk and support. Mesh is not supposed to shrink or change shape, and yet many removals show that the devices have shrunk by up to half their size. If you experience issues with your mesh, your surgeon will be very reluctant to remove it. Many surgeons will offer partial removal, citing full removal as too dangerous, however, those who have partial removals typically end up back on the operating table again for further surgeries. Each surgery creates more damage to surrounding tissues creating more scar tissue and increasing the risk of damaging organs within the pelvis (bladder, bowel etc.).
With all these facts to hand, the decision to have mesh implanted is not one to be taken lightly. If you do decide to take the risk, make sure your surgeon has a plan for what to do should you be that 1 person in 10 for whom things go disastrously wrong following your surgery.